DR. NAJIBA AL SHEZAWY

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Dr. Najiba has Co-Foundaed Professional Regulatory Affairs (PRA), a leading healthcare regulatory consultancy in the Middle East since 2013. To further uphold the ethics and compliance standards within the industry, she has also persevered with Dubai Pharmacy College, industry experts and authorities to set up the GCC Regulatory Affairs (RA) Course, a first-of-its-kind certification, which educates graduates and professionals on the new career advancements and opportunities in this sector to become industry experts.

DR. RAWYA KREDLY

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Dr. Rawya is a clinical pharmacist with broad Medical and Pharmaceutical knowledge, experience in various aspects of the Pharmaceutical Industry especially Medical Affairs, Regulatory Affairs and Pharmacovigilance, as well as knowledge and experience in the research field. She has a M.Sc. Clinical Pharmacy (with Distinction) – Queen’s University, UK.

Dr. Rawya began her career at Hikma Pharmaceuticals, Jordan since 1998 till 1999, and she is currently the Regulatory Affairs & Medical Affairs Director at Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, United Arab Emirates since 2020 – to the present date.

 

In her role in Regulatory affairs, she displays and actions leadership in all aspects of Regulatory Affairs for company product portfolio of generics and novel products, including product development and submissions.

She is also an expert in defining the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget. In addition, Dr. Rawya is knowledgeable of partnering with R&D and Global Strategic Marketing leaders as well another functional leader to develop and implement strategy for pipeline development and global launch excellence.

 

She exercises highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages overseas and balances resource allocation across critical projects; and is responsible for regulatory aspects of products lifecycle management.

 

Dr. Rawya maintains communication with global and regional/local regulatory agencies, and she ensures that company policies, procedures and practices are in compliance with regulatory requirements as well as assuring timely regulatory clearance for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives

DR. DOMINIKI KATI

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I am an experienced Life Sciences professional with significant exposure in the biotechnological and pharmaceutical industry for the past 6 years.

 

I have a rich academic background in Molecular Biology working in various research projects across different countries since 2012.

 

In 2015 I completed my Master of Science in Pharmaceutical Science with Distinction at Edinburgh Napier University, and shortly after graduating I began my career in R&D in Scotland, UK. I gained experience in leading and planning development activities and familiarized myself with validation requirements for in vitro diagnostics. My main focus was the technical transfer of processes from development to production in Switzerland.

 

In 2019 I worked in Medical and Commercial operations for a startup pharmaceutical services company in Dubai, UAE, having broad set of responsibilities across all business functions including medical and regulatory affairs.

 

In 2020, I started my journey in Pharmacovigilance with Genpharm Services, supporting the rare disease community in the MENA region. I am currently managing all pharmacovigilance activities in the region; I am responsible for the development and implementation of the internal Pharmacovigilance system, and I am acting as the Pharmacovigilance Officer for all safety reporting and monitoring.

 

In 2022, I was honored to receive the GCC Pharmacovigilance Award 2022 by the GCC Regulatory Affairs Pharma Summit.

DR. AHMED HEGAZY

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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.

  • He holds certificates on programs or courses from:
    • The George Washington University, USA
    • Columbia University, USA
    • Royal College of Physicians, UK
    • Hibernia College, Ireland
    • Uppsala Monitoring Center, WHO
  • 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.
  • 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.
  • Ahmed had been trained on ISO 9001-2015 Quality Lead Auditor Certification and Lean and Six Sigma Greenbelt Holder.

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

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

He owns more than 25 years of wealthy experience in Pharmaceutical Industry in different regions and

functions (sales, training, medical, marketing and PV).

  • 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.
  • He was holding a position of Head of Global Patient Safety for Africa, Middle East, Turkey, Russia & CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.

Currently he is a:

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