The webinar discusses the evolving pharmacovigilance and risk management environment of innovative therapies, emphasizing safety challenges in cell, CAR T, and RNA-based treatments, as well as gaps in regulation and surveillance strategies. Participants will gain insight into the origin and impact of safety concerns in these therapies, alongside ongoing developments in RNA-based treatments.
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.
Pharmacovigilance has become an essential discipline to ensure the safety of patients receiving innovative therapies. We will also discuss how authorities are addressing these treatments to minimize the risks.
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.
Register now
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Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.
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.
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.
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 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.
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