Speakers

Speakers 2025

The GCC Regulatory Affairs Pharma Summit 2025 gathers experts to explore regulatory updates, compliance, and pharma innovations in the Gulf.

Dr. Katya Nabeel Ailabouni

Position: Clinical Pharmacist & Pharmacovigilance Officer, - Emirates Drug Establishment (EDE), UAE
Categories: speakers 2025

Dr. Katya Nabeel Ailabouni is a Clinical Pharmacist with extensive experience in the UAE Ministry of Health. She holds an M. Pharm. in Clinical Pharmacy (2024, Al Ain University, UAE) and a B.Sc. in Pharmacy (1999, Philadelphia University, Amman, Jordan).

Since 2004, Dr. Katya has worked with the Ministry of Health’s Registration and Drug Control Department. From 2005-2008, she served as a Registration Officer, handling New Drug Applications, renewals, and manufacturing facility registrations. Since 2008, she has been a Pharmacovigilance Officer and a reporter for the UAE National Pharmacovigilance Committee.

Earlier in her career, Dr. Katya was the Pharmacist-in-Charge at Al Nahdha Pharmacy, Abu Dhabi (2002-2003), and a Pharmacist at Mermaid Pharmacy, Abu Dhabi (1999-2001).

Dr. Katya Nabeel Ailabouni

Clinical Pharmacist & Pharmacovigilance Officer, - Emirates Drug Establishment (EDE), UAE

Dr. Katya Nabeel Ailabouni is a Clinical Pharmacist with extensive...

Dr. Noura Abdelaal

Position: Head of Regulating Controlled Substances & Products, & Precursor Chemicals Section, & Head of Pharmacovigilance Section - Emirates Drug Establishment (EDE), UAE
Categories: speakers 2025

She is a qualified professional with 7 years of experience in the Drug Department, having worked across multiple functions, including the regulation of Narcotics, Psychotropics, and Precursor Chemicals. Her expertise extends to conducting GMP audits both locally and internationally, monitoring drug quality and safety, and investigating malpractice within the industry, all with a focus on ensuring the safe use of medicines across the country.

She has played a pivotal role in strengthening MOHAP’s partnerships with other federal entities, including the Ministry of Interior, the Federal Customs Authority, and the Weapons and Hazardous Substances Office, as well as collaborating with international organizations such as the World Health Organization (WHO) and the International Narcotics Control Board (INCB).

Dr. Noura Abdelaal

Head of Regulating Controlled Substances & Products, & Precursor Chemicals Section, & Head of Pharmacovigilance Section - Emirates Drug Establishment (EDE), UAE

She is a qualified professional with 7 years of experience...

Meet Our Speakers 2024

DR. HUSSAIN TALIB THANI AL RAMIMMY

Position: Director of Pharmacovigilance & Drug Information at The Drug Safety Center - Ministry of Health, Oman
Categories: Speakers 2024

Hussain Al Ramimmy is a Senior Specialized Pharmacist with over 25 years of experience. He is currently the director of Pharmacovigilance and Drug Information at the Drug Safety Center, Ministry of Health, Oman. Al Ramimmy obtained his bachelor’s degree in pharmacy from Strathclyde University, Glasgow in 1998 and the master’s degree in pharmacology from Glasgow Caledonian University in 2011.

DR. HUSSAIN TALIB THANI AL RAMIMMY

Director of Pharmacovigilance & Drug Information at The Drug Safety Center - Ministry of Health, Oman

DR. REEM EL ESSA

Position: Director of Drug Inspection Administration & Commissioned Superintendent for Pharmacovigilance Surveillance - MoH, Kuwait
Categories: Speakers 2024
  • PhD Pharmaceutical Regulations
  • MBA General and Strategic Management
  • MSc PV and Pharmacoepidemiology
  • Has a long experience in the regulatory and inspection practice
  • As well as the community pharmacy and pharmaceutical services in Kuwait.
  • Currently, has research interest in the field of health economics and Pharmacoeconomics and the economic value of PV.

DR. REEM EL ESSA

Director of Drug Inspection Administration & Commissioned Superintendent for Pharmacovigilance Surveillance - MoH, Kuwait

DR. ABEER ZEITOUN

Position: Clinical & Technical Manager, Lebanese National Pharmacovigilance Program - Ministry of Public Health, Lebanon
Categories: Speakers 2024

Dr. Abeer Zeitoun is a skilled specialist in Medication and Patient Safety with extensive experience in the field of public safety. Currently, Dr. Zeitoun holds the position of Clinical and Technical Manager at the Lebanese National Pharmacovigilance Program. She has more than 15 years of educational expertise, having held the role of Clinical Pharmacy Assistant Professor at the Lebanese American University (LAU). Her academic background includes a Pharm D degree from the Lebanese American University, complemented by a Master’s degree in Patient Safety from Massachusetts College of Pharmacy and Health Sciences. Additionally, Dr. Zeitoun is credited as an author in numerous publications.

DR. ABEER ZEITOUN

Clinical & Technical Manager, Lebanese National Pharmacovigilance Program - Ministry of Public Health, Lebanon

DR. RITA KARAM

Position: Director of Quality Assurance of Pharmaceutical Products Program (QAPPP) & National Pharmacovigilance Program Coordinator - Ministry of Public Health, Lebanon
Categories: Speakers 2024

Dr. Rita Karam, a Pharmacist with a Ph.D. in Pharmaceutical Sciences, is a Professor at the Lebanese University and holds key roles in healthcare governance as the Director of Quality Assurance of Pharmaceutical Products Program (QAPPP) and National Pharmacovigilance Program Coordinator. She is an active member of ISoP (International Society of Pharmacovigilance), and chairs the ISPOR-Arabic Network (The Professional Society for Health Economics and Outcome Research). With more than one hundred scientific articles and reports, her contribution span various fields in healthcare, including Health Technology Assessment, Health Economics, and Pharmacovigilance. This extensive body of work establishes her as a significant figure in academia and public health.

DR. RITA KARAM

Director of Quality Assurance of Pharmaceutical Products Program (QAPPP) & National Pharmacovigilance Program Coordinator - Ministry of Public Health, Lebanon

DR. WALAA EBRAHIM SABER

Position: Manager of Pharmaceutical Vigilance General Administration - Egyptian Drug Authority (EDA)
Categories: Speakers 2024

Bachelor’s degree in Pharmaceutical Sciences, and Master of Business Administration (MBA) Candidate-Arab Academy for science, technology and Maritime transport (AASTMT).

Previously:

  • Deputy Manager of Pharmaceutical Vigilance General administration
  • Manager of Pre- Marketing Vigilance Regulatory Affairs Administration
  • Pharmacovigilance committee rapporteur
  • PV specialist. – Egyptian Drug Authority (EDA)

Walaa Ebrahim, is an Administrative Manager with thirteen years of experience working within regulatory authorities. Walaa specializes in pharmacovigilance and is responsible of Supervising and management of pre marketing & post marketing administrations regarding  Human, Biological, Herbal, Medical devices,  Veterinary & Biocides safety units, Supervising the development of policy proposals, Regulatory and executive regulations for pharmaceutical vigilance, Supervising the evaluation of risk-benefit balance and risk management plans for pharmaceutical products and for medical devices,

Achievements

  • A representative of EDA in WHO regulatory training in swissmedic & many other training and scientific events.
  • Actively participated in EDA global benchmarking program conducted by the World Health Organization (WHO)
  • Principle contribution in the issuance and reviewing of the updated guideline on pharmacovigilance practice in Egypt (GVP)
  • Develop an appropriate Administrative & technical Manual on Pharmacovigilance practice regarding Human & Biological products illustrating the responsibilities of Marketing Authorization Holders.
  • Participated in the Pharmacovigilance inspections on marketing authorization holders.
  • Conducted advanced-level pharmacovigilance training sessions for pharmaceutical companies and their respective teams.
  • Participate in many EDA twining projects with other regulatory authorities.
  • Principle contribution in developing many EDA guidelines and polices.
  • Prepare and review the Standards Operating Procedures (SOPs) of whole Pharmacovigilance processes and continuously update them as appropriate.
  • Manage the Pharmacovigilance Committee and prepare safety issues to be discussed by the Committee as appropriate.
  • Takes/ recommends the appropriate regulatory actions where necessary based on the continuous monitoring of the safety profile for pharmaceutical products available in Egypt.
  • Develop work strategies &plans, delegate tasks & monitor the performance.

DR. WALAA EBRAHIM SABER

Manager of Pharmaceutical Vigilance General Administration - Egyptian Drug Authority (EDA)

DR. HAYAA BANAT

Position: Senior Pharmacovigilance Specialist & The Head of Pharmacovigilance Section - Jordan Food & Drug Administration (JFDA)
Categories: Speakers 2024

Dr. Hayaa Banat is a senior pharmacovigilance specialist and the Head of pharmacovigilance section at Jordan Food and Drug Administration (JFDA). Dr. Hayaa has more than 11 years’ experience in the field of Pharmacovigilance including ADR processing and assessment, Risk management, inspection and quality management.

She has participated in publishing many scientific articles in the areas of pharmacovigilance and antimicrobial resistance.

DR. HAYAA BANAT

Senior Pharmacovigilance Specialist & The Head of Pharmacovigilance Section - Jordan Food & Drug Administration (JFDA)

DR. EMAN GOMAA

Position: Middle East & Africa (MEA) PV Hub Lead - AbbVie
Categories: Speakers 2024

Eman has a wealth of experience in PV since 2012, with a strong network with decision makers in different health authorities. She held several senior roles in multiple multinational Pharma companies.

She started her PV career in Cairo, in 2012, at the very early beginnings of the Egyptian PV guidelines followed by the Arab GVP implementation in 2015.

She has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. After one year, she was selected to the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.

After Abbvie’s acquisition of Allergan in May 2020, Eman supported the global and affiliate PV integration workstreams and subsequently was appointed on May 2021 as the Lead of the Middle East & Africa PV hub, the largest PV hub in Abbvie.

She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.

Lastly, Eman has participated in GCC PV trainings that took place in Dubai, UAE, in years 2019 and 2020, 2021 and her sessions were widely recognized and got excellent feedback from the audience and regulators as well.

She also has multiple lectures in the annual PV course arranged by PRA and the Dubai Pharmacy College since 2020.

Eman is now the Middle East & Africa MEA Hub Lead in Abbvie and is a member of International Society of Pharmacovigilance ISoP, ISoP Middle East Chapter and the Country Representative in United Arab Emirates.

DR. EMAN GOMAA

Middle East & Africa (MEA) PV Hub Lead - AbbVie

DR. NAHED YAISH

Position: Owner & Founder - State Of Practices Consultancy Center (SOP)
Categories: Speakers 2024

20 experience in Pharma Industry.

15 years experience as Qualified Person Responsible for Pharmacovigilance/Local Safety Responsible, Quality Assurance Responsible Person.

Qualified International Trainer by International College in London.

Owner & Founder of State Of Practices Consultancy Center.

DR. NAHED YAISH

Owner & Founder - State Of Practices Consultancy Center (SOP)

DR. MICHELLE GEBARA

Position: Patient Safety Lead for UAE & Gulf Countries - Roche Pharmaceuticals
Categories: Speakers 2024

Dr. Michelle Gebara holds a Doctorate of Pharmacy degree from the Saint Joseph University of Beirut, Lebanon.

Throughout her journey in diverse regional and global pharmacovigilance roles within multinational pharmaceutical companies, she developed and enriched her passion for patient safety through multidisciplinary, innovative, and patient-centric approaches.

DR. MICHELLE GEBARA

Patient Safety Lead for UAE & Gulf Countries - Roche Pharmaceuticals

DR. RAGHDA MOHAMED HASSAN

Position: Patient Safety Cluster Lead , Gulf, Lebanon & KSA - Takeda
Categories: Speakers 2024

Dr. Raghda has rich experience in Pharmacovigilance and Patient Safety since 2011 when she starts establishment new pharmacovigilance system in Middle East and North Africa at Eli-Lilly from scratch.

she was working hand by hand with regulatory authority bodies within Middle East and North Africa region to implement and execute Arab Guidelines for Pharmacovigilance GVP first version.

She has several senior regional roles in multinational companies like Eli Lilly, Shire and now Takeda where she got diversified experience in Patient Safety in different geographical regions including not only Middle East and Africa but also some European countries like Greece, Portugal, Israel, Spain and Italy by which has been exposed to different experience that she builds on her area of expertise in Middle East and Africa region.

Dr. Raghda has passionate to Promote for Patient Safety in general and to optimize patient Safety awareness in specific within all health community sectors.

She is active member in different regional PV associations, and she is active moderators for DIA forums and different Global Pharmacovigilance events.

DR. RAGHDA MOHAMED HASSAN

Patient Safety Cluster Lead , Gulf, Lebanon & KSA - Takeda

DR. REEM ABDELJAWWAD MAHMOUD YASIN

Position: Quality Assurance & Pharmacovigilance Manager - Hawkary Pharmaceuticals Co.
Categories: Speakers 2024

Dr. Reem AbdelJawwad Mahmoud Yasin, the head of Quality Assurance and Pharmacovigilance in Hawkary Pharmaceuticals co., one of the top and leadings pharmaceutical’s companies in Iraq.

Dr. Reem AbdelJawwad Mahmoud Yasin, the head of Quality Assurance and Pharmacovigilance in Hawkary Pharmaceuticals co., one of the top and leadings pharmaceutical’s companies in Iraq.
She is a pharmacist graduated from University of Jordan and worked as lecturer there in the College of Pharmacy.

Dr. Reem has over 10 years of experience in the field of Integrated Quality Management, legal agreements and Pharmacovigilance in Jordan, Iraq, GCC and Europe.

Currently, she is a member of ISOP and member in Arab Quality consultants’ union (AQCU).

Certifications:

  • Certified ISO QMS consultant
  • German board in good manufacturing practices in pharmaceuticals industry
  • Certified in Pharmacovigilance professional
  • Certified with mini-MBA
  • Certified in Risk management professional
  • Certified Trainer

DR. REEM ABDELJAWWAD MAHMOUD YASIN

Quality Assurance & Pharmacovigilance Manager - Hawkary Pharmaceuticals Co.

MS. ALINA PANOURGIA

Position: Pharmacovigilance Consultant in UAE
Categories: Speakers 2024

Ms. Alina holds a bachelor’s degree in pharmacy from the University in Moscow, MBA and Msc in Pharmacovigilance from the UK Universities.

Ms. Alina is an experienced Quality Assurance Auditor and Regulatory Affairs professional who worked across the EU, US and APAC regions.

Since moving to the Middle East from Asia, Alina has worked as a freelancer in Pharmacovigilance, Regulatory Affairs and Quality improvements initiatives. Ms.  Alina covers GCC, LATAM and CIS regions for regulatory submissions while working with UK, US and EU companies on PV projects.

MS. ALINA PANOURGIA

Pharmacovigilance Consultant in UAE

DR. RANIA HAGGAG

Position: Pharmacovigilance Lead - Organon & Co.
Categories: Speakers 2024

She is a highly skilled Pharmacovigilance Lead for Gulf and Levant at Organon. Rania started her career as a Global Drug Safety Specialist Intern at MSD Americas. Her passion for drug safety and her exceptional skills helped her to climb the ladder of success.

Today, she leads the Gulf and Levant region in Pharmacovigilance, ensuring the safety and regulatory compliance of all drug-related activities at Organon. With a background in clinical pharmacy and a master’s degree in business management and marketing, Rania brings a unique and valuable perspective to her role as a Pharmacovigilance Lead.

DR. RANIA HAGGAG

Pharmacovigilance Lead - Organon & Co.

DR. DARSHI SHAH

Position: Senior Patient Safety & Education Manager for Business Area Middle East, Africa and Central Emerging Markets - Novo Nordisk
Categories: Speakers 2024

Dr. Darshi Shah is a pharmacist by profession. She has multi-functional working experience in Pharmacovigilance, Regulatory Affairs and Quality since 2013.

With over 10 years’ experience in various local and multinational Pharma companies, Darshi has been involved in shaping various Health Authority Legislations across different countries, shaping Quality Management Systems for Regulatory Affairs, Quality and Pharmacovigilance. She has proven capabilities in affiliate and regional PV governance as well as being savvy in audits and CAPA implementation.
Dr. Darshi believes that Patient Safety is a vital function and is everyone’s responsibility.

DR. DARSHI SHAH

Senior Patient Safety & Education Manager for Business Area Middle East, Africa and Central Emerging Markets - Novo Nordisk

DR. MOHAMED ABDEL HADY

Position: Patient Safety Associate Director - Gilead Sciences
Categories: Speakers 2024

Mohamed Abdel Hady is an accomplished pharmacovigilance professional with extensive experience in drug safety and regulatory compliance. With a background in pharmaceutical sciences, Mohamed has contributed significantly to the field through his work in adverse event reporting, risk assessment, and Industry groups across the GCC in well reputed Biotechnology companies.

Mohamed Abdel Hady holds a Master’s degree in Pharmacology from Alexandria University. He has worked with leading pharmaceutical companies across the GCC region. His expertise lies in ensuring patient safety by monitoring and evaluating drug safety data, implementing risk minimization strategies, and collaborating with cross-functional teams.

As a dynamic speaker, Mohamed has presented at various industry conferences and workshops including the World Drug Safety congress of Europe, Healthcare Automation and Digitalization Congress, DIA MENA and the Annual Risk Management and Pharmacovigilance Summit. His engaging sessions cover topics such as pharmacovigilance best practices, regulatory updates, and the role of the affiliates to apply the policies of the Pharmacovigilance HQs.

DR. MOHAMED ABDEL HADY

Patient Safety Associate Director - Gilead Sciences

DR. MARIE IBRAHIM

Position: Associate Director - Regulatory Affairs and Pharmacovigilance - IROS CRO
Categories: Speakers 2024

As the Senior Manager of Regulatory Affairs and Pharmacovigilance at Insights Research Organization and Solutions (IROS), Dr Marie leads operations associated with the conduct of clinical trials in accordance with all applicable regulations & study-specific requirements and ensures that research sites are prepared and have the necessary tools needed to start the trial. In addition, her department manages the safety profile of new drugs in clinical trials, oversees case-processing activities through all phases of development, and perform regulatory reporting and medical monitoring tasks.

Dr Marie has over 15 years of experience, the last 8 of which have been in Regulatory Affairs including the regulation of clinical research, continuous education, professional licensing, and auditing of health advertisements.

Prior to joining IROS, she headed the Research and Education Regulation Department at Dubai Healthcare City Authority where she oversaw the regulation of human subject research including non-interventional studies and complex clinical trials. She also sat on the IRB of Mohammed Bin Rashid University of Medicine and Health Sciences as the Regulatory Representative.

Dr Marie graduated with a degree of Doctor of Dental Surgery in 2008 and also holds a Master’s Degree in Healthcare Management and a Postgraduate Diploma in Clinical Leadership and Innovation from the Royal College of Surgeons in Ireland.

DR. MARIE IBRAHIM

Associate Director - Regulatory Affairs and Pharmacovigilance - IROS CRO

DR. JOËLLE ISSA – BLOK

Position: Regulatory Affairs & PV Director Middle East, Turkey & Africa, QPPV UAE & Oman - Acino
Categories: Speakers 2024

Dr. Joëlle Issa-Blok currently works at Acino MEA, UAE as Regulatory Affairs and Pharmacovigilance Director for the Middle East, Turkey and Africa region. She is as well the QPPV for the UAE and Oman.

She has 18 years’ experience in the pharmaceutical industry in different positions, starting in Regulatory Affairs Europe R&D in the Netherlands, then in various regional roles as Head of Regulatory Affairs and Pharmacovigilance MEA at Astellas where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations.

She lived and worked 10 years in the Netherlands where she gained her experience in EU RA & PV regulations. Joëlle is a Pharmacist graduated from the Saint Joseph University in Beirut, in addition she holds a Masters in Science degree in Drug Innovation Research & Development from the University of Utrecht in the Netherlands.

DR. JOËLLE ISSA – BLOK

Regulatory Affairs & PV Director Middle East, Turkey & Africa, QPPV UAE & Oman - Acino

DR. MAREEZ WILLIAM

Position: Regional Pharmacovigilance Manager META – Acino
Categories: Speakers 2024

Dr. Mareez William is Egyptian and has graduated from Faculty of Pharmacy Ain Shams University in 2012.

She is currently working as Regional Pharmacovigilance Manager (META) in Acino Pharmaceuticals from 2019.

She has set up Pharmacovigilance system for Acino in Egypt, KSA & UAE and responsible for PV activities in Middle East and Turkey.

She seeks professionalism in her career life & personal life as well, so Time Management is her KEY in achieving this!  Also, she is glad to join GCC Summit every year as she is passionate about Networking Growth and meeting other PV experts in the region.

DR. MAREEZ WILLIAM

Regional Pharmacovigilance Manager META – Acino

DR. AHMED ABDELRAHMAN

Position: Patient Safety and Pharmacovigilance (PSPV) lead for India, Middle East, Turkey, and Africa (IMETA) - Boehringer Ingelheim
Categories: Speakers 2024

Ahmed has more than 12 years of experience in Pharmacovigilance (PV) and Quality Compliance. He started his career in Egyptian Health Authority in Drug Factories inspections, then moved to Pharmacovigilance center before joining the Pharma companies as Qualified Person for Pharmacovigilance since 2015. Ahmed managed to establish and maintain efficient and complaint PV system in more than 21 countries throughout his years of experience in close partnership with Health Authorities and Local License Partners including Angola, Bahrain, Egypt, Ghana, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Mauritius, Nigeria, Oman, Pakistan, Qatar, Rwanda, Seychelles, Sudan, UAE, Uganda, and Yemen.

In his role as regional Patient Safety and Pharmacovigilance (PSPV) lead for India, Middle East, Turkey, and Africa (IMETA) at Boehringer Ingelheim; Ahmed is leading IMETA OPUs to act as patient ambassadors within the organization so that we can influence the internal and external environment to achieve the safest use of pharmaceutical products.

DR. AHMED ABDELRAHMAN

Patient Safety and Pharmacovigilance (PSPV) lead for India, Middle East, Turkey, and Africa (IMETA) - Boehringer Ingelheim

DR. YASMINE FEKRY

Position: Middle East Multi Country Safety Head , Global Pharmacovigilance - Sanofi
Categories: Speakers 2024

DR. YASMINE FEKRY

Middle East Multi Country Safety Head , Global Pharmacovigilance - Sanofi

DR. EMAD NAGUIB

Position: Global Safety Head, Middle East Region - MSD
Categories: Speakers 2024

DR. EMAD NAGUIB

Global Safety Head, Middle East Region - MSD

MS. DOLCINEA CHIRAZI

Position: Business Development Director - The Applied AI Company (AAICO)
Categories: Speakers 2024

With a keen eye for detail and a strong history in defense industry bid management, Dolcinea took up the role of Business Development Director with AAICO at the end of 2022, as they relocated their global HQ to Abu Dhabi. At AAICO she leverages her passion for innovation and emerging technologies to successfully drive growth across various verticals.

Dolcinea holds a Masters Degree in Law and a Bachelor of Arts in Communication, which brings a unique perspective to her role. Known for her approachable nature and collaborative spirit, Dolcinea is dedicated to taking others on the journey of discovering the power of artificial intelligence in healthcare.

MS. DOLCINEA CHIRAZI

Business Development Director - The Applied AI Company (AAICO)

Meet Our Speakers 2023

Dr. Katya Nabeel Ailabouni

Position: Pharmacovigilance officer Working at Ministry of Health - Prevention / Drug Department (MOH) in UAE
Categories: Speakers 2023

Dr. Katya is the Pharmacovigilance officer Working at Ministry of Health – Prevention / Drug Department (MOH) in UAE
She’s also the Pharmacovigilance office reporter of the UAE National Pharmacovigilance Committee from 2008 till this day.

Dr. Katya was also the registration Officer for new drug application, renewal of registration, minor variation, manufacturing facilities registration and local manufacturer registration as well at the Ministry of Health and Prevention (MOH) in UAE.

As for Dr. Katya’s educational background, she has a B.SC Pharmacy from Philadelphia University in Amman Jordan

Dr. Katya Nabeel Ailabouni

Pharmacovigilance officer Working at Ministry of Health - Prevention / Drug Department (MOH) in UAE

Dr. Jaber M. Jaber

Position: Head of the rational drug use and pharmacovigilance department at Jordan food and drug administration (JFDA)
Categories: Speakers 2023

Jaber M. Jaber, head of the rational drug use and pharmacovigilance department at Jordan food and drug administration (JFDA).

Pharmacist Jaber is a senior pharmacovigilance specialist with more than 18 years of experience in both public and private sector. Pharmacist by education, obtained master’s degree in pharmacology from the university of Jordan.

He had participated in several committees like the validation of the method of analysis, re-registration for originator & generic medicines and currently the head of health hazard evaluation committee.

Jaber is a member in the international society of pharmacovigilance (ISoP) and a member in the Brighton collaboration.

Dr. Jaber M. Jaber

Head of the rational drug use and pharmacovigilance department at Jordan food and drug administration (JFDA)

DR. SYED ZAFERUDDIN

Position: Global Vigilance Manager & QPPV at Julphar, UAE
Categories: Speakers 2023

Syed Zaferuddin is a Pharmacovigilance & Medical Device vigilance professional working as Global Vigilance Manager & QPPV at Julphar UAE. In past worked for companies like Jamjoom Pharma, TCS, Cognizant and Clinnovo. He is a speaker for World Drug Safety Congress in Europe and America. Skilled in Good Clinical Practice (GCP), Pharmacovigilance, Medical Device vigilance, Drafting Agreements, management of ICSR, aggregate reports, Pharmacovigilance intelligence, PV QMS, PV safety database and PV LMS. A strong legal professional with a Master’s Degree focused on Pharmacology. Also heading an NGO aims to increase the ICSR reporting culture in the Middle East.

DR. SYED ZAFERUDDIN

Global Vigilance Manager & QPPV at Julphar, UAE

DR. MAHA ALJMI

Position: Patient safety Lead for Saudi Arabia in Boehringer
Categories: Speakers 2023

Dr. Maha is responsible for establishing pharmacovigilance system in the country with high quality and efficiency standards.

Dr. Maha has a bachelor’s degree in pharmacy from KSU, and she has 15 years of experience working within various sectors of the pharmaceutical industry having working across a range of key areas sales, medical affairs and pharmacovigilance functions. She has involved in audits and inspection visits.
Got several awards during her career from several departments due to her achievements.

Member in the Saudi Pharmaceutical Society – No. of membership is 4407 Since 2004 (1425 H) –Had been active Member in the Public Relations Committee – Saudi Pharmaceutical Societyز

She has a good understanding of the challenges in maintaining regulatory compliance utilizing different methods of implementation. She is passionate about the importance of ensuring patient safety via building a better awareness and understanding of pharmacovigilance.

 

DR. MAHA ALJMI

Patient safety Lead for Saudi Arabia in Boehringer

DR. RAGHDA MOHAMED HASSAN

Position: Pharmacovigilance Lead for Middle East & turkey Cluster at Takeda
Categories: Speakers 2023

Raghda Has rich experience in Pharmacovigilance and Patient Safety since 2011 when she starts establishment new pharmacovigilance system in Middle East and North Africa at Eli-Lilly from scratch.

And she was working hand by hand with regulatory authority bodies within Middle East and North Africa region to implement and execute Arab Guidelines for Pharmacovigilance GVP first version.

She has several senior regional roles in multinational companies like Eli Lilly, Shire and now Takeda where she got diversified experience in Patient Safety in different geographical regions including not only Middle East and Africa but also some south European countries like Greece, Portugal, Israel, Spain and Italy by which has been exposed to different experience that she builds on her area of expertise in Middle East and Africa region.

Raghda has passionate to Promote for Patient Safety in general and to optimize patient Safety awareness in specific with full health community sectors.

She is active member in different regional PV associations, and she is active moderator for DIA forums and different Global Pharmacovigilance events.

DR. RAGHDA MOHAMED HASSAN

Pharmacovigilance Lead for Middle East & turkey Cluster at Takeda

DR. MIRHAN ISMAIL

Position: Safety Operation Lead for Middle East & Africa Region at AbbVie
Categories: Speakers 2023

Merihan has multi-functional and diversified working experience in (Pharmacovigilance, drug safety and clinical research) since 2010.

Possessing 12 years’ experience in multinational pharmaceutical companies with getting involved in all pharmacovigilance activities locally & globally, starting from Novartis pharma in Cairo then joined Abbvie biopharmaceuticals in 2015 as pharmacovigilance specialist Gulf, relocated in Dubai in 2015, then promoted to be PV manager/ASR Gulf in 2018.

After AbbVie’s acquisition of Allergan in May 2020, merihan supported the global and local PV integration’s network in building the Middle East & Africa PV hub strategy and was appointed as Middle East & Africa safety operations & compliance lead.

Merihan also got the Master of Business Administration degree in 2013 as well as the Dubai health authority license in 2015.

She also has a great experience in delivering trainings to different stalk holders as pharmaceutical companies, third parties, distributors, and clinical research organizations, as well as being part of GCC PV training in 2019 in, her session was well recognized by the audience.

Merihan also is working to elevate the PV brand and overcoming the PV challenges and obstacles by being part of trade associations like Middle East and Africa EFPIA IPVG Work stream as well as the Pharma group in Egypt.

Merihan believes that Pharmacovigilance is crucial function as it is related to the patients’ safety and that should be everyone’s responsibility.

DR. MIRHAN ISMAIL

Safety Operation Lead for Middle East & Africa Region at AbbVie

DR. FLORAH MATLALA

Position: Head of Pharmacovigilance Unit of South African Health Products Regulatory Authority (SAHPRA)
Categories: Speakers 2023

Florah is a pharmacist by profession currently heading the pharmacovigilance unit of South African Health Products Regulatory Authority (SAHPRA). She holds BPharm and master’s in pharmacy with specialisation in Pharmacovigilance & Pharmacoepidemiology. She joined SAHPRA in 2011 as Medicine Registration Officer in the Pharmaceutical & Analytical Directorate and later Head the Vigilance unit since October 2015 to date. She has experience in different pharmacy sectors, including medicines regulation, retail and hospital pharmacy. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.

She supports the National Immunisation Safety Expert Committee and member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.

DR. FLORAH MATLALA

Head of Pharmacovigilance Unit of South African Health Products Regulatory Authority (SAHPRA)

DR. RAGHAV PAI

Position: Pharmacovigilance Leader with Passion For Patient Safety with expertise In APAC, MEA, And Eurasian Region PV:
Categories: Speakers 2023

Pharmacovigilance Leader with Passion For Patient Safety with expertise In APAC, MEA, And Eurasian Region PV:

20+ years in pharmaceutical industry specializing in pv and clinical research.

15+ years of international pv leadership experience, coaching and empowering next-gen pv leaders.

Proficiency in pre and post marketing pv regulatory requirements in apac, middle east, and Eurasian region.

Proven expertise in building, developing, and executing pv qms, regional and affiliate pv governance model.

Savvy in pv audits/ inspections and capa implementation.

Track record of strong personal performance combined with demonstrated ability to build and lead a high performing team.

DR. RAGHAV PAI

Pharmacovigilance Leader with Passion For Patient Safety with expertise In APAC, MEA, And Eurasian Region PV:

DR. MARIAN ANWAR

Position: Benefit Risk & Therapeutic Area Lead, Middle East & Africa, at AbbVie
Categories: Speakers 2023

Dr. Marian is a strategic and accomplished leader with more than 15 years of resounding success in Pharmacovigilance, Clinical Research, Medical affairs and Business Development within the Pharmaceutical industry across the Middle East and Africa region.

Distinguished career reflects scientific expertise in promoting the safe use of pharmaceutical products through PV system development, product vigilance, and risk assessment/mitigation strategies.

Dr. Marian started her career as a medical representative in Cairo, Egypt and then relocated to Dubai, UAE , where she held several regional senior roles in different top multinational pharmaceutical companies.

Dr. Marian accomplished Extensive knowledge of Pharmacovigilance regulations and practices in the assigned territories with profound experience in quality control and management of PV procedures with high level of collaboration with relevant stakeholders. Recognized as a Subject Matter Expert with track record of success in providing PV insights through safety assessments, regulatory compliance, PV partnership and drug safety audits.

DR. MARIAN ANWAR

Benefit Risk & Therapeutic Area Lead, Middle East & Africa, at AbbVie

MS. KAREN TAYLOR

Position: Head of the Centre for Health Solutions at Deloitte - UK
Categories: Speakers 2023

Karen established Deloitte UK’s Centre for Health Solutions in November 2011. The Centre is the independent research arm of Deloitte’s Life Sciences and Health Care (LSHC) practices, providing a trusted source of relevant, timely and reliable insights on emerging trends, challenges, and solutions. The Centre combines creative thinking, robust research, and industry experience to develop evidence-based perspectives on some of the biggest and most challenging issues facing our life sciences and healthcare clients to help them to improve efficiency and cost-effectiveness and, importantly, benefit the patient.

Karen’ recent life sciences focus has been on a series of six reports on how AI is transforming the pharma value chain <a href=”https://www2.deloitte.com/uk/en/insights/industry/life-sciences/ai-in-biopharma.html?icid=learn_more_content_click” tabindex=”-1″>AI In Biopharma Collection | Deloitte Insights</a>; with the most recent being <a href=”https://www2.deloitte.com/uk/en/insights/industry/life-sciences/artificial-intelligence-in-healthcare-pharmacoviligance.html” tabindex=”-1″>AI in health care pharmacovigilance</a>.&nbsp; Previous research relevant to compliance includes a series of ten predictions on the life sciences and healthcare in the regulatory impact is a cross cutting theme – <a href=”https://www2.deloitte.com/uk/en/pages/life-sciences-and-healthcare/articles/life-sciences-and-health-care-predictions.html” tabindex=”-1″>The future unmasked (deloitte.com)</a> <a href=”https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-life-sciences-healthcare-predictions.pdf” tabindex=”-1″>deloitte-uk-life-sciences-healthcare-predictions.pdf</a> &nbsp;and an earlier report <a href=”https://www2.deloitte.com/uk/en/pages/life-sciences-and-healthcare/articles/life-sciences-predictions-2025.html” tabindex=”-1″>A bold future for life sciences regulation | Deloitte UK</a>.

Karen is a member of the Institute of Chartered Public Finance and Accountants and has extensive experience in leading research into healthcare and life-science issues in the UK and internationally.&nbsp; Between 1997 and 2010 Karen was the Director of Health Value for Money (VFM) Audit at the UK’s National Audit Office, and received an OBE for her work on Health VFM work. Karen was a Non-Executive Director (NED) at Dartford and Gravesham NHS Trust from 2011 to 2021, where she chaired the Quality and Safety Committee for six years and the Audit Committee for four years. Since 2022 Karen has been a NED at Kent Community NHS Foundation Trust and a member of the Workforce and Quality and Safety Committees.

MS. KAREN TAYLOR

Head of the Centre for Health Solutions at Deloitte - UK

DR. SHAIMAA ELMELIGY

Position: Pharmaceutical affairs Director Aspen healthcare- MENAT
Categories: Speakers 2023

Pharmacist with more than 20 years of experience in pharma industry, &nbsp;graduated from Alexandria university -Egypt, worked in many companies on national and international level in different roles.

She has a diversified experience as she managed registration and compliance&nbsp;of &nbsp;Pharmaceuticals, medical devices, cosmetics and FMCG products across the region.in her current tenure she is managing the regulatory affairs, Pharmacovigilance , quality, quality technical projects and medical promotional compliance across and Turkey region at Aspen MENAT.

She is a Certified auditor, holds a certificate in leadership, she has passion about patency laws, so she is certificated in pharmaceutical intellectual property law and recently she received a certificate in industrial biotechnology.

DR. SHAIMAA ELMELIGY

Pharmaceutical affairs Director Aspen healthcare- MENAT

DR. ADO H. MUHAMMAD

Position: CEO of Pharmedas Clinical Research & Consultancy (UAE, UK, USA)
Categories: Speakers 2023

Dr. Muhammad worked extensively in general medicine and orthopaedic surgery including a postgraduate degree at the Institute of Orthopaedics of the University College London before joining the pharmaceutical industry more 20 years ago. He worked in in early phase units and subsequently for PPD Inc, GW Pharmaceuticals, InMed Pharmaceuticals, Ipsen and AstraZeneca amongst others. He has also worked for the Nigerian regulatory agency, supporting the pharmacovigilance and post-marketing directorate.

Dr. Muhammad underwent pharmaceutical medicine specialty training at the UK’s Faculty of Pharmaceutical Medicine of the Royal College of Physicians as well as the postgraduate course at University of Wales in Cardiff between 2007 and 2011. Dr Muhammad also holds an MBA in pharmaceutical industry management. His expertise is in patients’ safety and pharmacovigilance and is a Board Member of the Faculty of Pharmaceutical Medicine.

Dr. Muhammad is a global health enthusiast and advocate, particularly in the areas of social justice, planetary, environmental, and social determinants of health. He is a fellow of the UK’s Faculty of Public Health of the Royal College of Physicians.

DR. ADO H. MUHAMMAD

CEO of Pharmedas Clinical Research & Consultancy (UAE, UK, USA)

DR. SHAHINAZ BADR

Position: Pharmacovigilance Consultant and PVQA Auditor - EMEA at Pharma Quality Europe
Categories: Speakers 2023

Shahinaz, pharmacist with more than 20 years’ experience in pharmacy and pharmaceutical business, currently working as Pharmacovigilance Consultant and auditor for PQE Group covering the EMEA region. Started her career as a clinical pharmacist in Cairo University Medical School Teaching Hospital integrating with top HCPs of different specialties in interdisciplinary healthcare systems, where safety monitoring was always an integral part of clinical practice.

Leveraging on her expertise, she joined the pharmaceutical industry working in Regulatory Affairs and later on regional positions before focusing on Pharmacovigilance. Actively working in pharmacovigilance regulatory Intelligence in a role enabling her to interact with industry colleagues and Competent Authority Pharmacovigilance departments.

Dr. Shahinaz has contributed to several international initiatives and partnerships to help support patient safety and improve the monitoring of drugs for safety.&nbsp; She is an active member the ISOP Special Interest Group collaborating in the initiation of the GPPC (Global Pharmacovigilance Certificate).

DR. SHAHINAZ BADR

Pharmacovigilance Consultant and PVQA Auditor - EMEA at Pharma Quality Europe

STAVROS KARDAHAKIS, PHD

Position: Head of Business Consulting at EXTEDO
Categories: Speakers 2023

Stavros joined EXTEDO’s Customer Care back in November 2020, where he has been acting as the Head of Business Consulting services for the last 1.5 years.

He is steering EXTEDO’s business consultants in delivering services in the fields of Agency support, Industry RIMS, Publishing, and Pharmacovigilance.

Before joining EXTEDO has was managing the core drug safety group of a major European drug manufacturer, overseeing pharmacovigilance and XEVMPD services for hundreds of clients. In parallel he was tasked with services portfolio expansion, domain business development and to act as point of contact with IT, Clinical Affairs, and QA teams. Notable achievements in his decade with the organization include a complete restructuring of the business operating procedures, establishing new service opportunities, contributing to the revenue and human capital growth, securing the reputation of the team, while successfully sustaining multiple EMA, NCA and client audits.

His previous assignment was a Deputy QPPV for a generic company, where he implemented the entire pharmacovigilance system from scratch.

Stavros is a Chemist by academia and holds a PhD in Molecular Quantum Mechanics.

STAVROS KARDAHAKIS, PHD

Head of Business Consulting at EXTEDO

DR. ANDREA STRIEBEL

Position: Product Manager at EXTEDO
Categories: Speakers 2023

Dr. Andrea Striebel is Product Manager at EXTEDO GmbH, located near Munich (Germany). In her role she is responsible for the Safety Hub at EXTEDO and works closely together with the entire Product Management Team. Prior to taking over the PM role she started as Senior Business Consultant at EXTEDO in January 2016 and was working on customer projects. She is not only following the latest developments in pharmacovigilance, but also related to IDMP. Before joining EXTEDO she worked in the pharmaceutical industry for more than 11 years focusing on pharmacovigilance topics.

First as a scientist and later she took over the team leader position for global drug safety and in 2011, she became QPPV. In her role, she was responsible for establishing and maintaining the global pharmacovigilance system within the company. Being QPPV, Andrea was also involved in audits and inspections as well as XEVMPD topics. Additionally, she gave pharmacovigilance trainings and held presentations at national and international conferences.

DR. ANDREA STRIEBEL

Product Manager at EXTEDO

MR. MICHAEL FAUST

Position: RCC Business Consultant at EXTEDO
Categories: Speakers 2023

Since 2017 Michael supports the EXTEDO team as Business Consultant, focusing on drug regulation and registration. He is active in EXTEDO’s Regulatory Competence Center, where he monitors regulatory standards worldwide. His focus regions are Europe, EAEU, Asia, and the Middle East including GCC countries.

Michael is a professional regulatory and software trainer for EXTEDO’s customers globally. He manages customer projects, provides advanced regulatory customer support, and publishing services. He has more than five years of experience with regulatory and technical, tool-specific consulting on EXTEDO’s product portfolio in projects with industry and agency customers worldwide.

MR. MICHAEL FAUST

RCC Business Consultant at EXTEDO

DR. RASHA TAWFIK

Position: PV Manager MEA and LPPV at Bausch Health
Categories: Speakers 2023

&nbsp;is a Pharmacovigilance manger and serves as LPPV for Middle East / Africa region for Bausch Health US, she also held position at global SDEA team.

Rasha is pharmacist by education, she held master’s degree in molecular biology and diploma in pharmacovigilance.

She previously served as regulatory affair specialist responsible for regulatory submission &amp; regulatory intelligence.

She had previous experience at molecular biology field, she served as molecular biology and research lab associate. She served also as Clinical pharmacist.

In her PV role, Rasha manages daily operational activities, Oversee partner qualification. Support partner PV system creation and maintenance and ensure partner compliance as well as enforce SDEA execution.

Her ultimate goal is patient safety, improving PV awareness in MEA countries to assist medication safety decisions making and to ensure collected information is more relevant and applicable to domestic populations in the region.

DR. RASHA TAWFIK

PV Manager MEA and LPPV at Bausch Health

DR. NAHED YAISH

Position: General Manager of State Of Practices Consultancy Center
Categories: Speakers 2023

19 years experience in Pharmaceutical Field
14 years experience as QA Responsible Person, QPPV/LSR and Regulatory Affairs for Local &amp; International Pharmaceutical Companies
4 years Experience as BD, QA, RA &amp; PV consultant for Manufacturer and drugstores located in (Jordan)
Established System for QA, PV &amp; RA which passed successfully local inspections &amp; European audits.
Qualified International Trainer by International College in London (ICL)</li>
Owner &amp; Founder of State Of Practices Consultancy Center (SOP Consultancy Center)

DR. NAHED YAISH

General Manager of State Of Practices Consultancy Center

DR. EVA KOPECNA

Position: Head of Global Regulatory Affairs, Medical & Pharmacovigilance at Acino
Categories: Speakers 2023

Dr. Eva works for Acino International as a Head of Global Regulatory Affairs, Medical and Pharmacovigilance and is a member of management of the company. She has 20+ year experience at pharmaceutical industry in different positions, starting in R&D as a medical expert, than as Head of clinical trials, and finally she moved to Regulatory Affairs where she has been building and leading different Regulatory Affairs, Pharmacovigilance and Medical Affairs teams and organisation supporting R&D activities, new submissions, LCM activities for finished products and actives substances. In addition, Eva has wide experience with mergers & acquisitions & integration and divestment activities.

Dr. Eva is a medical doctor with 1st and 2nd degrees in Internal Medicine, in addition she holds MSc. degree in Regulatory Affairs from Cardiff University in the UK, Ph.D. in Pharmacy from Charles University in Prague. Eva is the author of several scientific publications, including one book on GCP. Eva has been TOPRA MSc module leader or co-leader for 4 TOPRA modules since 2007. Eva is winner of TOPRA Award in Regulatory Excellence and served 4 years a member of Board of TOPRA Directors.

DR. EVA KOPECNA

Head of Global Regulatory Affairs, Medical & Pharmacovigilance at Acino

PHARMACIST, MSC. JOËLLE ISSA – BLOK

Position: Regulatory Affairs & PV Director Middle East, Turkey & Africa, QPPV UAE & Oman at Acino
Categories: Speakers 2023

Joëlle Issa-Blok currently works at Acino MEA, UAE as Regulatory Affairs and Pharmacovigilance Director for the Middle East, Turkey, and Africa region. She is as well the QPPV for the UAE and Oman. She has 17 years’ experience in the pharmaceutical industry in different positions, starting in Regulatory Affairs Europe R&D in the Netherlands, then in various regional roles as Head of Regulatory Affairs and Pharmacovigilance MEA at Astellas where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations. She lived and worked 10 years in the Netherlands where she gained her experience in EU RA & PV regulations. Joëlle is a pharmacist graduated from the Saint Joseph University in Beirut, in addition she holds a Masters in Science degree in Drug Innovation Research & Development from the University of Utrecht in the Netherlands.

PHARMACIST, MSC. JOËLLE ISSA – BLOK

Regulatory Affairs & PV Director Middle East, Turkey & Africa, QPPV UAE & Oman at Acino

MS. ALINA PANOURGIA

Position: Pharmacovigilance Consultant in UAE
Categories: Speakers 2023

Alina holds a bachelor’s degree in Pharmacy from the University in Moscow and MBA degree from Nottingham University, UK.

Alina is an experienced Quality Assurance Auditor and Regulatory Affairs professional who worked across the EU, US and APAC regions.

Since moving to the Middle East from Asia, Alina has worked as a Regulatory, PV and Quality freelancer. Alina covers MENA, LATAM and CIS regions for regulatory submissions while working with UK and EU companies on PV projects.

Alina is due to complete her Thesis in Pharmacovigilance on  “Post-authorisation safety studies in EU and MENA regions.

MS. ALINA PANOURGIA

Pharmacovigilance Consultant in UAE

DR. MANAL YOUNUS

Position: Director of Iraqi Pharmacovigilance Center based in MOH - Iraq
Categories: Speakers 2023

Dr Manal Younus is an ISoP Fellow and is currently the Director of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy.

She led the creation and the expansion of the Iraqi pharmacovigilance system. Currently, she is an Advisory Board member of the International Society of Pharmacovigilance (ISoP) and working with students to increase the awareness regarding pharmacovigilance. She is an Executive Committee member of the Council of International Organizations of Medical Sciences (CIOMS).

Manal is co-founder of the ISoP Patient Engagement SIG, the vice president of the ISoP Middle East chapter, and ISoP Pharmacovigilance Professional Qualification Framework SIG member. She had authored more than 30 articles in different drug safety related subjects.

She is a WHO benchmarking assessor. Finally, a member of the International Academy of Public Health (IAPH) Scientific Council and Antimicrobial Resistance Specialty committee member.

DR. MANAL YOUNUS

Director of Iraqi Pharmacovigilance Center based in MOH - Iraq

DR. KATYA NABEEL AILABOUNI

Position: Pharmacovigilance Officer at Ministry of Health - Prevention / Drug Department (MOH) - UAE
Categories: Speakers 2023

Dr. Katya is the Pharmacovigilance officer Working at Ministry of Health – Prevention / Drug Department (MOH) in UAE.

She’s also the Pharmacovigilance office reporter of the UAE National Pharmacovigilance Committee from 2008 till this day.

Dr. Katya was also the registration Officer for new drug application, renewal of registration, minor variation, manufacturing facilities registration and local manufacturer registration as well at the Ministry of Health and Prevention (MOH) in UAE.

As for Dr. Katya’s educational background, she has a B.SC Pharmacy from Philadelphia University in Amman Jordan

DR. KATYA NABEEL AILABOUNI

Pharmacovigilance Officer at Ministry of Health - Prevention / Drug Department (MOH) - UAE

Meet Our Speakers 2022

Dr. Eman Gomaa

Position: MEA Pharmacovigilance Hub Lead at AbbVie
Categories: speakers 2022

Eman has a wealth of experience in PV since 2012; with a strong network with decision makers in different health authorities. She held several senior roles in multiple multinational Pharma companies.

She started her PV career in Cairo, in 2012, at the very early beginnings of the Egyptian PV guidelines followed by the Arab GVP implementation in 2015.

She has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. After one year, she was selected to the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.

After Abbvie’s acquisition of Allergan in May 2020, Eman supported the global and affiliate PV integration workstreams and subsequently was appointed on May 2021 as the Lead of the Middle East & Africa PV hub , the largest PV hub in Abbvie.

She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.

Lastly, Eman has participated in GCC PV trainings that took place in Dubai, UAE, in years 2019 and 2020, 2021 and her sessions were widely recognized and got excellent feedback from the audience and regulators as well.

She also has multiple lectures in the annual PV course arranged by PRA and the Dubai Pharmacy College since 2020.

Eman is now the Middle East & Africa MEA Hub Lead in Abbvie and also is a member of International Society of Pharmacovigilance ISoP, ISoP Middle East Chapter and the Country Representative in United Arab Emirates.

Dr. Eman Gomaa

MEA Pharmacovigilance Hub Lead at AbbVie

Dr. Syed Zaferuddin

Position: Global Vigilance Manager & QPPV at Julphar, UAE
Categories: speakers 2022

Syed Zaferuddin is a Pharmacovigilance &amp; Medical Device vigilance professional working as Global Vigilance Manager &amp; QPPV at Julphar UAE. In past worked for companies like Jamjoom Pharma, TCS, Cognizant and Clinnovo. He is a speaker for World Drug Safety Congress in Europe and America. Skilled in Good Clinical Practice (GCP), Pharmacovigilance, Medical Device vigilance, Drafting Agreements, management of ICSR, aggregate reports, Pharmacovigilance intelligence, PV QMS, PV safety database and PV LMS. A strong legal professional with a Master’s Degree focused on Pharmacology. Also heading an NGO aims to increase the ICSR reporting culture in the Middle East.

Dr. Syed Zaferuddin

Global Vigilance Manager & QPPV at Julphar, UAE

Ms. Alina Panourgia

Position: Pharmacovigilance Consultant – UAE
Categories: speakers 2022

Alina holds a bachelor’s degree in Pharmacy from the University in Moscow and MBA degree from Nottingham University, UK.

Alina is an auditor and has experience in Quality Assurance and Regulatory Affairs across EU, US and APAC regions.

Since moving to the Middle East from Malaysia Alina has been working as a freelancer in Quality, Regulatory and PV in GCC and Russia, while working on her Master`s degree in Pharmacovigilance with the Drug Safety Research Unit (DSRU, UK).

She also currently supports research on Drug Safety and Risk/Benefit Assessment with the University of Hertfordshire, UK.

Ms. Alina Panourgia

Pharmacovigilance Consultant – UAE

Dr. Ahmed Hegazy

Position: Managing Director PVigilant
Categories: speakers 2022

Dr. Ahmed Hegazy is a Physician by education and holds a Master’s degree in Pharmaceutical Medicine.

(First Class Honor), Mini MBA, Medical Quality Management Diploma and Hospital Management Diploma.

<ul>
<li>He holds certificates on programs or courses from:</li>
<li>
<ul>
<li>The George Washington University, USA</li>
<li>Columbia University, USA</li>
<li>Royal College of Physicians, UK</li>
<li>Hibernia College, Ireland</li>
<li>Uppsala Monitoring Center, WHO</li>
</ul>
</li>
<li>He attended many trainings in leadership, strategic thinking, decision-making, brand planning, building efficient teams, high performance, accountability, communication skills, and persuasion and selling skills.</li>
<li>Moreover, He attended courses in Outcome Research and Health Economics, Drug discovery and development, Medical Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.</li>
<li>Ahmed had been trained on ISO 9001-2015 Quality Lead Auditor Certification and Lean and Six Sigma Greenbelt Holder.</li>
</ul>

Dr. Ahmed received various awards and recognitions in innovation (Upjohn Award), achievements and others.

<ul>
<li>He has scientific publications in international journals.</li>
<li>Advisory Board, Committee member or member to International Scientific Journals, Associations and Conferences.</li>
<li>He is a member of Emirates Medical Association</li>
<li>He is a member of Emirates Health Economics Society</li>
<li>He is a member of the ISoP society and was a committee member of the ISoP Middle East Chapter.</li>
<li>He was invited as a speaker for hundreds of local, regional, international events and on TV as well as various online programs.</li>
<li>He attended numerous (~100s) conferences and events.</li>
</ul>

<p>He owns more than 25 years of wealthy experience in Pharmaceutical Industry in different regions and</p>

<p>functions (sales, training, medical, marketing and PV).</p>

<ul>
<li>He is an Expert in the Medical Affairs as he worked for 11 years in various positions in the Medical Affairs (Sr. Manager, Regional Manager and Head) in which he got experience in all MA roles, clinical research, governance, compliance, quality. He possesses strong medical knowledge in various therapeutic areas and many products’ portfolios. Currently, he conducts medical development programs.</li>
<li>He was holding a position of Head of Global Patient Safety for Africa, Middle East, Turkey, Russia &amp; CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.</li>
</ul>

<p><strong>Currently he is a:</strong></p>

<ul>
<li>Consultant for Medical Affairs, and Pharmacovigilance for Global, Regional and Local companies.</li>
<li>Senior Auditor for an international EU-based firm.</li>
<li>Speaker, Lecturer and Trainer for some colleges, companies, and health authorities.</li>
</ul>

Dr. Ahmed Hegazy

Managing Director PVigilant

Ms. Rehab AbdelAziz

Position: Regulatory Affairs & Pharmacovigilance Manager- MENAT- Aspen HealthCare FZ LLC
Categories: speakers 2022

Ms. Rehab is the Regulatory Affairs & Pharmacovigilance Manager- MENAT- Aspen HealthCare FZ LLC. She has 14 years experienced pharmacist with a diversified expertise and a high exposure to the medical registration and regulatory issues as well as deep understanding of the registration requirements and procedures of the MENA Ministries of Health. Previously she worked as a Regulatory Affairs & Pharmacovigilance Manager at Aspen HealthCare FZ LLC. Prior to that she was also the Senior Regulatory Affairs & Labelling Associate MENAT at Aspen HealthCare FZ LLC and she began with Pfizer Consumer Healthcare as a Regulatory Affairs Officer in 2017

Ms. Rehab AbdelAziz

Regulatory Affairs & Pharmacovigilance Manager- MENAT- Aspen HealthCare FZ LLC

Ahmed Zeitoun

Position: Regulatory Affairs Lead, Roche Pharmaceuticals Middle East
Categories: speakers 2022

Ahmed is a pharmaceutical industry professional with over 10 years of experience in regulatory health authority engagement, pharmaceutical product licensing and lifecycle maintenance, market access/reimbursement, good pharmaceutical&nbsp;manufacturing, distribution and quality management.

He started his career with GSK in 2011 and moved to Roche in 2020. He has been a standing representative on the Regulatory Affairs Working Group (PHRMAG) since 2015, and has been leading UAE policy advocacy efforts on behalf of the group since 2021.

He is a licensed pharmacist and a published academic. He holds a Bachelor of Science in Pharmaceutical Sciences and Biotechnology from the German University in Cairo.

Ahmed Zeitoun

Regulatory Affairs Lead, Roche Pharmaceuticals Middle East

Samar El Gendy

Position: Country Safety Head & QPPV for the Gulf affiliate at Biogen
Categories: speakers 2022

Samar El Gendy is a Country Safety Head &amp; QPPV for the Gulf affiliate at Biogen. She has a very diverse cross-functional experiences working in several roles in Quality, Commercial Excellence, Learning &amp; Development, Medical Operations &amp; Excellence, Governance, Compliance, Regulatory and Pharmacovigilance.

Samar is a key strategic partner for the local business and provides valued consult and collaboration to all affiliate stakeholders and functions to support local objectives. Her passion for pharmacovigilance started since she was a student, and she sees Pharmacovigilance instrumental in ensuring that patients come first.

Furthermore, she is a strong believer of the value of “great workplace” and she had stretched herself above and beyond her call of duty where she has been appointed as Women’s Leadership Initiative lead and a Chief Wellness Officer during her time in GSK and currently she is a council member of the Diversity, Equity and Inclusion at Biogen BIR region.

Samar is a pharmacist by qualification, a Global Health nerd, a volunteering advocate, a pianist by passion and a believes that every day is an opportunity to learn something new.

Samar El Gendy

Country Safety Head & QPPV for the Gulf affiliate at Biogen

Joëlle Issa-Blok

Position: Regulatory Affairs, Quality and Pharmacovigilance Director for the Middle East, Turkey and Africa region at ACINO
Categories: speakers 2022

Joëlle Issa-Blok works at Acino MEA, UAE as Regulatory Affairs, Quality and Pharmacovigilance Director for the Middle East, Turkey and Africa region. She has 16 years’ experience in the pharmaceutical industry in different positions, starting in Regulatory Affairs Europe R&D in the Netherlands, then in various regional roles as Head of Regulatory Affairs and Pharmacovigilance MEA where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations. Joëlle is a Pharmacist, in addition she holds a MSc degree in Drug Innovation R&D from the University of Utrecht in the Netherlands.

Joëlle Issa-Blok

Regulatory Affairs, Quality and Pharmacovigilance Director for the Middle East, Turkey and Africa region at ACINO

Ahmed Abdelrahman

Position: Regional Patient Safety and Pharmacovigilance Lead India, Middle East, Turkey, Africa at Boehringer Ingelheim
Categories: speakers 2022

Ahmed has more than 12 years of experience in Pharmacovigilance (PV) and Quality Compliance. He started his career in Egyptian Health Authority in Drug Factories inspections, then moved to Pharmacovigilance center before joining the Pharma companies as Qualified Person for Pharmacovigilance since 2015.

Ahmed managed to establish and maintain efficient and complaint PV system in more than 14 countries throughout his years of experience in close partnership with Health Authorities and Local License Partners including Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Pakistan, Qatar, Sudan, UAE, and Yemen. In his role as regional Patient Safety and Pharmacovigilance (PSPV) lead for India, Middle East, Turkey and Africa (IMETA) at Boehringer Ingelheim; Ahmed is supporting and leading IMETA OPUs to act as Patient ambassadors within the organization so that we can lead the internal and external environment to achieve the safest use of our products.

Ahmed Abdelrahman

Regional Patient Safety and Pharmacovigilance Lead India, Middle East, Turkey, Africa at Boehringer Ingelheim

Dr. Eva Kopečná

Position: Head of Global Regulatory Affairs, Medical and Pharmacovigilance at ACINO
Categories: speakers 2022

Dr. Eva Kopečná works at Acino International, Switzerland as Head of Global Regulatory Affairs, Medical and Pharmacovigilance. She has spent more than 23 years in the pharmaceutical industry in different positions, starting in R&D as a medical expert, then as Head of clinical trials, and finally she moved to Regulatory Affairs where she has been building and leading different Regulatory Affairs, Pharmacovigilance and Medical Affairs teams and organizations supporting R&D, Regulatory and Pharmacovigilance activities. Eva is a Medical Doctor with 1 <sup>st</sup> and 2<sup>nd</sup> degrees in Internal Medicine, in addition she holds a MSc. degree in Regulatory Affairs from Cardiff University in the UK and Ph.D. in Pharmacy from Charles University in Prague. Eva is the author of several scientific publications, including one book on GCP. Eva has been TOPRA MSc module leader or co-leader for four TOPRA modules since 2007 and is teaching in other universities on Regulatory and GCP topics. Eva is a winner of TOPRA Award in Regulatory Excellence and is currently a member of Board of TOPRA Directors.

Dr. Eva Kopečná

Head of Global Regulatory Affairs, Medical and Pharmacovigilance at ACINO

Dr. Mirhan Ismail

Position: Safety Operation Lead for Middle East & Africa Region at AbbVie
Categories: speakers 2022

Merihan has multi-functional and diversified working experience in (Pharmacovigilance, drug safety and clinical research) since 2010.

Possessing 12 years’ experience in multinational pharmaceutical companies with getting involved in all pharmacovigilance activities locally &amp; globally, starting from Novartis pharma in Cairo then joined Abbvie biopharmaceuticals in 2015 as pharmacovigilance specialist Gulf, relocated in Dubai in 2015, then promoted to be PV manager/ASR Gulf in 2018.

After AbbVie’s acquisition of Allergan in May 2020, merihan supported the global and local PV integration’s network in building the Middle East &amp; Africa PV hub strategy and was appointed as Middle East &amp; Africa safety operations &amp; compliance lead.

Merihan also got the Master of Business Administration degree in 2013 as well as the Dubai health authority license in 2015.

She also has a great experience in delivering trainings to different stalk holders as pharmaceutical companies, third parties, distributors, and clinical research organizations, as well as being part of GCC PV training in 2019 in, her session was well recognized by the audience.

Merihan also is working to elevate the PV brand and overcoming the PV challenges and obstacles by being part of trade associations like Middle East and Africa EFPIA IPVG Work stream as well as the Pharma group in Egypt.

Merihan believes that Pharmacovigilance is crucial function as it is related to the patients’ safety and that should be everyone’s responsibility.

Dr. Mirhan Ismail

Safety Operation Lead for Middle East & Africa Region at AbbVie

Dr. Marian Anwar

Position: PV Partnership Lead, Middle East & Africa, at Abbvie
Categories: speakers 2022

Dr. Marian is a strategic and accomplished leader with more than 15 years of resounding success in Pharmacovigilance, Clinical Research, Medical affairs and Business Development within the Pharmaceutical industry across the Middle East and Africa region. Distinguished career reflects scientific expertise in promoting the safe use of pharmaceutical products through PV system development, product vigilance, and risk assessment/mitigation strategies.

Dr. Marian started her career as a medical representative in Cairo, Egypt and then relocated to Dubai, UAE , where she held several regional senior roles in different top&nbsp;multinational&nbsp;pharmaceutical companies,” Novartis , GSK, Allergan and Abbvie”.

Dr. Marian accomplished Extensive knowledge of Pharmacovigilance regulations and practices in the assigned territories with profound experience in quality control and management of PV procedures with high level of collaboration with relevant stakeholders. Recognized as a Subject Matter Expert with track record of success in providing PV insights through safety assessments, regulatory compliance, PV partnership and drug safety audits.

Dr. Marian Anwar

PV Partnership Lead, Middle East & Africa, at Abbvie

Mr. Sattam Turky Alghodyyr

Position: Director, Regulatory Affairs, SPIMACO
Categories: speakers 2022

Sattam Turky Alghodyyr began his career as a pharmacist at King Khalid Hospital, AIMajma’ah, but soon moved to the Saudi Food &amp; Drug Authority gaining unparalleled experience in the Bioequivalence, while also establishing himself as an expert inP harmacovigilance.
In 2016 he started at Saudi Pharmaceutical Industries and Medical Appliances Corporation-SPIMACO as the Pharmacovigilance and Bioequivalence Manager where he is now Director of Regulatory Affairs.

Sattam is the Founding Member of the Pharmaceutical Industry Association PIA, Member of the Board of Directors ARAC Healthcare Oct 2018 and a Committee member representing SPIMACO on the National Committee for Pharmaceutical Industries NCPI.

Mr. Sattam Turky Alghodyyr

Director, Regulatory Affairs, SPIMACO

Dr. Reem Al-Essa

Position: the Coordination & Development Superintendent at Ministry of Health Kuwait
Categories: speakers 2022

Dr. Reem Al-Essa has a PhD in Pharmaceutical Regulations and an EU2P MSc in Pharmacovigilance and Pharmacoepidemiology, with a long and diversified experience in both government and private sectors in Kuwait.

She started her career in Kuwait Ministry of Health in September 1999, Drug and Food Control, Pharmaceutical and Herbal Medicines Registration and Control Administration as a Regulatory Reviewer of Pharmaceutical Registration Dossier. She was promoted to become the Head of Drug Registration Department, and then Drug Registration and Release Superintendent. She then moved from the Government career to join the community pharmacy field and worked on the raising the community’s awareness in ADR reporting, Pharmacovigilance and Medication Management Services in the private sector since 2013. With her continuous passion in Pharmacovigilance, Dr. Reem became an active Pharmacovigilance Advocate in the social media since 2016 with her social media presence under the title “Report Me Kuwait”. She then reached an opportunity to continue making positive changes in her field at the Ministry of Health, so she made her mind to end her community practice in the private sector and moved back to MOH in 2017 to work in the Drug Inspection Administration carrying out the role of pharmacy licensing and inspection in addition to her role as a PV focal point and PV Advocate in the social media.

Dr. Al-Essa became The Coordination and Development Superintendent at the Pharmaceutical Services Administration, Ministry of Health in 2019. She is responsible for ensuring the best quality pharmaceutical care practice at government hospitals and primary healthcare clinics, which include the availability of safe and effective treatments as well as coordinating any safety issues related to the use of medications with the phamacovigilance team at the Drug and Food Control sector.

Dr. Reem Al-Essa

the Coordination & Development Superintendent at Ministry of Health Kuwait

Mr. Nathan Seyoum

Position: External Medicine Dossier Assessor at Ethiopian Food and Drug Authority (EFDA)
Categories: speakers 2022

He graduated from Clinical Pharmacy at the Addis Ababa University and he’s currently finalizing my Master’s degree in Medicine Regulatory Affairs. Mr. Nathan is  an academician at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy. In addition he is the Co founder and Vice President of East Africa Regulatory Affairs Professionals Association. He works closely with the Ethiopian Food and Drug Authority (EFDA) in the medicine registration, inspection and PR departments. He also works as an external regulatory consultant for medicine registration.

Mr. Nathan Seyoum

External Medicine Dossier Assessor at Ethiopian Food and Drug Authority (EFDA)

Mr. Mick Foy

Position: Head of Pharmacovigilance Strategy at the MHRA
Categories: speakers 2022

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Senior Leadership team.

He has been manager of the Vigilance Intelligence and Research Group for 10 years and in 2019 become Head of Pharmacovigilance Strategy.

Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation and WHO.

Mick continues to have oversight of the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems.

He is currently leading the MHRA’s transformation of vigilance systems with a remit to develop common IT and methodologies for medicines and devices.

Mick is Chair of the MedDRA Management Committee, and a member of the Uppsala Monitoring Centre Board.

Mr. Mick Foy

Head of Pharmacovigilance Strategy at the MHRA

Dr. Emad Eldin Munsour

Position: Supervisor Pharmacist at the Pharmacy & Drug Control Department, Ministry of Public Health (MoPH), Qatar
Categories: speakers 2022

Dr. Emad Eldin Munsour is a supervisor pharmacist at the Pharmacy and Drug Control Department, Ministry of Public Health (MoPH), Qatar. He has completed his PhD in pharmacy practice from Universiti Sains Malaysia, Penang, Malaysia. His professional experience started as a drug information and clinical pharmacist at Sri Ramakrishna hospital; Lecturer of Pharmacy Practice Department at University of Medical Sciences and Technology and Regulatory Affairs Manager (East Africa) at Hikma Pharmaceuticals Ltd.

He led the development of Qatar National Formulary (QNF) as a website and mobile application, Dr. Emad also served in the capacity of QNF editor and committee member from January 2013 till now. He participated in the comprehensive restructuring of Qatar’s drug regulatory teams and cross-functional processes. Dr. Emad is the focal point, Qatar Pharmacovigilance Center (Associate Member of Uppsala Monitoring Center, WHO). He served as the coordinator for Qatar National Drug Coding Project, Qatar Pharmaceutical Track and Trace System and Qatar National Medicines Security Strategy.

Dr. Emad served as an external member, the Graduate Supervisory Committee, College of Pharmacy, Qatar University and as a representative of the Pharmacy and Drug Control Department for Qatar’s National Health strategy (2018-2022).

Dr. Emad Eldin Munsour

Supervisor Pharmacist at the Pharmacy & Drug Control Department, Ministry of Public Health (MoPH), Qatar

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