EMA Roadmap Update: PMS Capabilities and the End of the Legacy Era
Alpa Ben
25 Jun, 2025
Dr. Alpa Ben is a Senior Subject Matter Expert in Medical Devices Team at Celegence. She brings over 13 years of experience in regulatory affairs and medical writing, with expertise in evaluating EU-MDR compliant documentation.
Her experience includes reviewing CEP, CER, SSCP, PMS, and PMCF and provide scientific justification for equivalence, state-of-the-art, benefit-risk analysis, and clinical claims, supporting compliance with EU MDR. She has worked across various therapeutic areas, including dentistry, cardiology, gastroenterology, nephrology, and diagnostic & interventional radiology.
Dr. Alpa Ben holds a Bachelor of Dental Surgery (BDS) from Rajiv Gandhi University of Health Sciences (RGUHS) and Post Graduate Diploma in Clinical Research and Pharmacovigilance. With her academic and industry experience, Dr. Alpa Ben supports global regulatory programs and contributes to compliant and efficient regulatory outcomes.
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