Dr. Radwa Abd Ellah Sayed is a highly accomplished professional with a distinguished career in quality assurance and regulatory affairs within the Egyptian Drug Authority. Her dedication to quality and expertise in regulatory systems have been instrumental in both national and international advancements. Currently, Dr. Radwa serves as a Senior Quality Assurance Specialist within the General Administration of Quality Assurance at the EDA.

Qualifications:

• Master’s degree in Biochemistry from the Faculty of Science at Cairo University in 2019, where the thesis focused on evaluating the effectiveness of vaccines containing tetanus

• Bachelor’s degree in Chemistry and Biochemistry from the Faculty of Science in

Certificates and Training:

• Diploma in Total Quality Management from Brooklyn

• Certified Project Management Professional (PMP) from the Project Management Institute (PMI).

• Completed numerous trainings and workshops in various fields of the

Career Highlights:

• Joined the National Organization for Research and Control of Biologicals in

• Progressed in the National Organization for Research and Control of Biologicals in the Lot Release

• Qualified for the position of Deputy Manager of the Lot Release Department in

• Joined the Technical Office of the Central Administration for Biologicals, Clinical Studies, and Innovative Products from February 2019 to September

• Qualified for the position of Manager of the Vaccines and Sera Lot Release Unit in

• Assigned tasks as Quality Supervisor for Lot Release Management, in addition to her role as Manager of the Vaccines and Sera Release Unit in

• In 2022, joined the General Administration of Quality Assurance as a Document Control Officer, then as a Risk Management Officer in 2023.

• Assigned various other tasks within the administration such as Coordinator for the Institutional Excellence Award from the General Quality Management and Performance Indicators Monitor for the authority, and Coordinator for the Media office.

Contributions to Quality and Regulatory Systems and the achievements:

• Contributed to the preparation of the Lot Release risk-based

• Prepared all work procedures for Lot Release administration according to the new

• Speaker at the first workshop held by the Egyptian Drug Authority in 2021 on Lot Release

• Speaker at a workshop for Lot Release administration held by the Egyptian Drug Authority for companies on Product Quality Review (PQR).

• Member of the WHO GBT for vaccines (Lot release function) task force as Unit Manager and Quality

• Contributed to the preparation of the Egyptian Drug Policy and coordinated between various stakeholders and prepared the draft presented to the World Health

• Member of the WHO GBT for pharmaceuticals (Regulatory system function) task

• Member of the RCORE team on the Regulatory

• Member of governance committees and monitoring committees for corrective actions within the

• Prepared a file to qualify for the Best Team Award in one of the categories of the Egyptian Drug Authority’s competition in 2023 under the supervision of the General Manager of the General Administration of Quality Assurance and obtained first place in this

• Member of the training team in the training program of the Yemeni High Authority for Medical Supplies on the topic:

1. Data Integrity and Good Documentation Practice: The Foundation of

• Speaker at workshops and training sessions for General Quality Management to spread quality culture and increase awareness of the quality system in various topics:

1. QMS Documentation and Document Control: The Foundation of

2. Navigating Uncertainty: Effective Risk Management

3. Driving Success: Navigating Key Performance Indicators for Optimal

Awards and Honors:

1. Certificate of appreciation for dedicated efforts in achieving WHO GBT (Level 3 maturity) accreditation for vaccines in 2022.

2. The General Quality Assurance Management team won first place in the Best Team category in the Excellence Award competition from the Egyptian Drug Authority for

3. EDA HEROS Employee Excellence Award for their outstanding efforts, remarkable contributions, and positive impact in 2023.

4. Certificate of appreciation for tremendous efforts in implementing the new Integrated Quality Management System in 2023.

Head of Quality Compliance, Audit and Technical Projects for Aspen Pharma covering Europe and Middle East.

A quality leader with a wealth of experience garnered from both industry and working with a national competent authority (HPRA, Ireland).

A diverse 18-year career within the pharmaceutical industry across R&D, Quality Control, Quality Assurance, Compliance and Technical Affairs covering sterile and non-sterile products. Leveraging an in-depth understanding of global regulatory requirements to apply a unique insight into the intricacies of compliance.

Successfully managed numerous multi-million-dollar technology transfer projects internationally.

Has a passion for mentoring and building a quality culture that stands the test of time while working towards the primary goal of ensuring product safety, efficacy, and quality.

He is an experienced professional in the pharmaceutical industry, with more than 23 years of experience within different functions and countries. serving as a Distribution and Commercial Relations Manager in Bayer. With a keen understanding of market dynamics and a knack for building strong relationships with distributors, he excels in establishing  the distribution management model for Bayer pharma in the ME and building strategic partnership to pave the way for Bayer access in GCC, Levant  and Egypt through different go to market models.

Experienced Pharmacist in Quality Assurance with 9+ years’ experience in the pharmaceutical industry. Skilled in Quality Management Systems, Documentation Management, training and GxP implementation. Passionate about Quality Assurance and implementation of GDP across the supply chain and warehouses through auditing and mentoring. Holder of a pharmaceutical Doctorate from Lebanese American University following clinical rotations at the Methodist Hospital Houston. Currently working as Quality Assurance Manager covering Gulf and Levant at AbbVie Biopharmaceuticals GmbH.

Dr. Ayman is a Regional LOC Quality Executive at Haleon for Gulf, Near East & KSA with former experience in North Africa, French West Africa, and Southern Africa in addition to being a Subject matter expert in Analytical science and technology for MEA region. Dr. Ayman is a Lead internal and external quality auditor in addition to being an Experienced Technical Services and Stability section head with a demonstrated history of working in the pharmaceuticals industry, Pharmaceutics, Statistical Data Analysis, Lean Six Sigma. In addition, Dr. Ayman is a master’s degree holder in Drug technology and Pharmaceutics from Ain Shams University, Egypt.

Education & Certificates:

– Bachelor of Pharmaceutical Sciences – Ain Shams University, Egypt

– Masters in Drug Technology & Pharmaceutics – Ain Shams University, Egypt

– Certified Black Belt Six Sigma – American Society for Quality (ASQ)

– Certified Quality Auditor – American Society for Quality (ASQ)

Research & Publications

– Optimization of Analytical Method for Simultaneous Determination of Acetaminophen, Caffeine, and Aspirin in Tablet Dosage Form

Pharmaceutical Chemistry Journal · Mar 18, 2023

– Nanoemulsion as a feasible and biocompatible carrier for ocular delivery of travoprost: Improved pharmacokinetic/pharmacodynamic properties

International Journal of pharmaceutics · May 1, 2020

With over 15 years of experience in life science production, quality assurance, and supply chain operations, he is a seasoned professional who strives for continuous improvement and excellence in his field.

He is responsible for establishing and leading the quality management framework and system for the cluster, covering 64 countries in the Middle East and Africa region.

He works closely with the EMEA Senior Director and the regional teams to ensure compliance with local and global regulations, as well as to mitigate potential or actual non-compliance risks. His mission is to enable and facilitate world-class operational and customer-focused capabilities while fostering a culture of innovation and collaboration.

Fabrizio Maniglio is an industry thought leader and the Director of Industry and Business Development for Honeywell. He leverages vast subject matter expertise to drive innovation for the industry and within Honeywell, where he continuously monitors the evolution of the ever-changing healthcare and life-sciences sectors. He fosters contacts with other industry thought leaders and regulators to collaborate and influence the future of our industry.

He contributed five years as an Expert Solutions Engineer with Honeywell – Sparta Systems, deepening his understanding of quality life cycle management and the life science industries. He was a key differentiator in helping customers achieve their quality management goals.

Before Sparta Systems, he served nine years at a leading European-based Contract Manufacturing Organization (CMO) in the Pharma, Biotech, and Specialty ingredients industry. He served in numerous global quality-related roles, spanning Deviations Management, Head of Audit QA and Compliance, and most recently as QA Manager for Data Integrity and Computer Systems Validation in Switzerland, the UK, and China.

As a result, Fabrizio provides a blend of deep industry, QMS, and cutting-edge technical knowledge and is uniquely placed to advise customers and the industry on the future of quality.

Salma Khalifa is a pharmacy and biotechnology bachelor’s degree holder with a Post-graduate Diploma in Total Quality Management & Six Sigma certification. She has extensive experience of 12 years in the development and implementation of Quality Management Systems, including compliance, auditing, dealing with Health Authorities, and leading quality governance end to end across the full chain from design until reaching patients. Sara’s experience also includes driving global projects, implementing changes across the organization, leadership, and operational excellence.

Ingenious Quality Leader with over 23 years of profound GxP experience in sterile/nonsterile pharmaceutical and medical device within the context of Technical Ops, Manufacturing, CMO, Distribution and Commercial operations including over 12 years in a leadership position in multinational business culture. His experience spans across North America, EMEA and China.

He had a track record of leveraging multidisciplinary teamwork to establish and sustain a fit for purpose risk based QMS in accordance with USFDA, EU, Health Canada, and GCC regulations for sites globally. He was keen on fostering a culture of Data Integrity compliance and achieving corporate compliance governance which resulted in outstanding regulators inspection outcomes.

At a Global role, Mr. Mazen played a pivotal role in driving various business initiatives such as Pharma 4.0 and governance compliance programs, leveraging his strengths in risk-based critical thinking, problem-solving, and proactive process control.

His leadership has led to quality transformations and seamless integration of new acquisitions worldwide, showcasing his precision and efficiency in executing strategic initiatives. Further, he deployed operational excellence utilizing lean manufacturing principles and kaizen tools, which optimized processes, reduced product defects, and positively impacted the bottom line, while upholding stringent quality standards.

A hallmark of Mr. Mazen’s career is his distinctive collaborative leadership style, forward-thinking mindset, integrity, unwavering commitment to continuous improvement and recognition as a change agent characterized by agility and resilience.  These attributes have established him as a respected professional in the industry.

Mona is the Senior Quality Manager at Haleon responsible for Gulf, Near East & Saudi Arabia. She is the Risk Management lead in Middle East Africa and subject matter expert for Deviation, Investigation, RCA and CAPA.

Before this, she held the role of Quality Head in Merck responsible for Egypt and Africa Developing Markets.

She has also been appointment to multiple roles as QMS champion, Data Integrity lead as well as Validation & CSV lead

In addition to this, Mona is a Lead Quality auditor, pharmaceutical sites’ due diligence and inspection readiness expert

• Education & Certificates:

–           Bachelor of Pharmaceutical Sciences – Cairo University, Egypt

–           Certified Quality Manager – American Society for Quality (ASQ)

Julie Zingarelli is a biomedical engineer with 9 years of experience in quality systems and compliance bringing a unique blend of industry expertise dealing with FMCGs and Pharmaceuticals in Switzerland.

She currently provides consultancy services focused on Inspection Readiness, including data governance and provides coaching prior to any virtual, hybrid or on-site audit.

• 20 experience in Pharma Industry
• 15 years experience as Qualified Person Responsible for Pharmacovigilance/Local Safety Responsible, Quality Assurance Responsible Person
• 5 years experience as Consultant for RA- Business Development, Pharmacovigilance & QMS
• Qualified International Trainer by International College in London
• Owner & Founder of State Of Practices Consultancy Center

Mohamed Hayani Quality Assurance Manager handling the MENA region at NewBridge,  has over 20 years of experience within the pharmaceuticals industry manufacturing facilities and commercial operations.

Quality Assurance professional with progressive experience with market-leading multinationals in pharmaceutical worked with senior leadership teams at regional on strategic initiatives aimed to grow and reshape businesses, I have successfully increased efficiency and productivity while reducing cost.

Mohamed Hayani is a holder of a bachelor’s degree in Applied Chemistry from Aleppo University, and holder of a CMQ certificate at ASQ (American Society for Quality).