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.