Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety
Agenda
00:00 – Introduction
03:30 – The Evolution of Pharmacovigilance & Therapies
05:00 – Current Regulatory Landscape for Advanced Therapies
06:35 – Navigating Cell & CAR T Therapies
17:09 – RNA-based Therapies
30:00 – Key Challenges in Pharmacovigilance for Innovative Therapies
39:00 – Q&A²

Speakers
Dr. Almudena Del Castillo Saiz
Dr. Almudena del Castillo, a Medical Doctor and Specialist in Family and Community Medicine, is an expert in pharmacovigilance within the pharmaceutical industry.
With a strong interest in regulatory affairs and drug safety, she has held roles at major pharmaceutical companies like Pfizer. She later applied her combined scientific and business vision at leading life sciences consultancies, including Pharmalex and PLG, as VP of Sales and Business Development.
Currently, as Global Division Head of Drug Safety and Vigilance at QbD Group, she drives globally focused solutions in safety, regulatory compliance, and strategic medical affairs.
Anam Ahmad
Anam holds a BSc in Pharmaceutical and Cosmetic Sciences and has developed a strong career in pharmacovigilance, supporting clinical trials, marketing authorisation applications, and post-marketing activities in the UK and internationally.
She acts as the UK QPPV and local pharmacovigilance contact, ensuring regulatory compliance and effective safety oversight. She brings broad expertise in pharmacovigilance and is recognized for her proactive, solutions-focused approach and strong commitment to medicine safety.
Dr. Laura Fragata Tavares
Dr. Laura Fragata holds a Doctor of Veterinary Medicine degree and is trained as a Qualification and Validation Coordinator. She began her career in quality assurance within the biopharmaceutical industry, working on medical device projects and ensuring compliance with industry standards.
Currently, Laura works in the pharmacovigilance department at our HQ in Belgium, where she supports various safety-related activities across different types of health products in both clinical and post-marketing settings.