On Wednesday, December 4, 2024, Gulf Medical University hosted a career advising session titled “Regulatory Affairs and Pharmacovigilance”. The session was presented by two professionals: Dr. Ahmed Elhelaly, Country Safety Head at Gulf Opella Healthcare International SAS, and Dr. Samah El Bakrawi, Regulatory Affairs Manager at Leptir Regulatory and Consultant Solutions. The event drew a diverse audience, including faculty members and students from various academic levels.
Dr. Ahmed Elhelaly, is a Pharmacovigilance Lead at Sanofi GCC, he oversees pharmacovigilance operations across the UAE, Qatar, Oman, Bahrain, and Kuwait. His responsibilities include maintaining a robust pharmacovigilance system through close collaboration with Customer Health Care (CHC) regional PV team. Dr. Samah El Bakrawi, has over 13 years of experience in regulatory affairs, including a decade with the Saudi Food and Drug Authority (SFDA) and three years with regulatory bodies in the UAE, namely the Ministry of Health and Prevention (MOHAP), and Dubai Municipality.
The session began by outlining key career pathways for pharmacists, such as licensed pharmacists, medical sales, regulatory affairs, and pharmacovigilance. Dr. Elhelaly elaborated on the important role of regulatory affairs departments in pharmaceutical companies, emphasizing their responsibility to secure and sustain approvals for pharmaceutical products. He also provided an overview of the major regulatory authorities across various regions, including: UAE: Ministry of Health and Prevention (MOHAP), KSA: Saudi Food and Drug Authority (SFDA), USA: Food and Drug Administration (FDA), Canada: Health Canada, UK: Medicines and Healthcare Products Regulatory Agency (MHRA), and Europe: European Medicines Agency (EMA).
Dr. Elhelaly further detailed the responsibilities of regulatory affairs specialists, shedding light on their critical role in navigating and complying with complex regulations to ensure public safety.
The interactive session concluded with a vibrant discussion, where attendees explored the unique opportunities within regulatory affairs and pharmacovigilance.