Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

This webinar explores the evolving landscape of pharmacovigilance and risk management in innovative therapies, focusing on safety challenges in cell, CAR T, and RNA-based treatments, and addressing gaps in regulatory frameworks and surveillance strategies.

Join us and stay ahead in drug safety: navigate the complexities of tomorrow’s therapies today!

26 June 2025

15:00 CEST

Pharma & BioTech

English

About the webinar

As innovative therapies like cell, CAR T, and RNA-based treatments transform modern medicine, they also present new and complex safety challenges.

This webinar delves into the critical aspects of pharmacovigilance and risk management necessary to support these advances. Participants will gain insight into the origin and impact of safety concerns in cell and CAR T therapies, including how impurities may compromise therapeutic profiles and the implications of regulatory misalignment.

The session will also cover the ongoing revolution in RNA-based therapies, outlining their therapeutic potential alongside emerging safety risks. Attendees will learn about current pharmacovigilance strategies tailored to these novel products and explore future perspectives in managing evolving risks.

Designed for professionals in drug safety, regulatory affairs, and clinical development, this webinar offers a vital opportunity to stay informed and prepared in an ever-changing therapeutic landscape.

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What you'll learn

Discover strategic approaches to risk management in the development of innovative treatments.
Understanding on the unique safety challenges associated with cell and CAR T therapies.
Learn the fundamentals and mechanisms behind RNA-based therapeutic technologies.
Identify key pharmacovigilance concerns specific to RNA-based therapies and how to address them.
Prepare for the future of drug safety by recognizing evolving risks and opportunities in cutting-edge therapies.

Speakers

Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.

Don’t miss the opportunity to learn and engage with professionals in the field.

Dr. Almudena Del Castillo Saiz

Head of Drug Safety & Vigilance, QbD Group

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

Senior PV Associate

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

Pharmacovigilance Consultant

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 pharmacovigilance, where she supports various safety-related activities across different types of health products in both clinical and post-marketing settings.