24 September, 2024

Navigating the Latest Revisions in GVP: Key Updates on Module XVI and Risk Minimization Measures

FREE WEBINAR TOPIC

“Navigating the Latest Revisions in GVP: Key Updates on Module XVI and Risk Minimization Measures”

 

This webinar will provide critical insights for Marketing Authorisation Holders and applicants, covering the role of risk minimization in risk management planning and its impact on the risk-benefit balance of medicinal products. We will also explore methods for evaluating the effectiveness of these measures.

 

Join us on October 26th for an in-depth review of the latest updates to GVP Module XVI, with a focus on Risk Minimization Measures (aRMMs).

 

Agenda:
  • Relevant updates to Module XVI – Risk minimization measures (Rev 3).
  • Updates to Module XVI Addendum II – Methods for evaluating effectiveness of risk minimization measures.

At the end of the webinar, you will have the opportunity to ask our expert any questions you may have.

 

About our expert speakers:

Elena Alcaraz Garcia

EU QPPV, UK QPPV, Strategic Advisor, PrimeVigilance

Elena joined PrimeVigilance in 2021. She has more than 15 years of working experience in different pharma companies. She currently holds the position of Strategic Advisor in the QPPV Department, acting as EU QPPV and UK QPPV for several clients. During her professional career she has specialised in the field of product’s safety, focusing in Human Pharmacovigilance (from generics to originals) but also in Veterinary Pharmacovigilance and Cosmetovigilance. She is an active lecturer in different master’s degrees with focus in Pharmaceutical Industry.

In terms of education, Elena holds a degree in Pharmacy from Universidad Complutense in Madrid (Spain) and also a Master’s Degree in Pharmaceutical Industry.

Mercedina Del Papa

EU QPPV, UK QPPV, Strategic Advisor, PrimeVigilance

Mercedina is a pharmacist with a master’s degree in “Pharmacovigilance and Regulatory Affairs” and a second master’s in “Management & Marketing in Pharmaceutical Industry” with more than 15 years of experience in Regulatory Affairs, Pharmacovigilance, Advertising, and Scientific Services. Mercedina joined PrimeVigilance in 2021 and she currently acts as the EU QPPV and the UK QPPV for clients as well as she is currently focusing on strategic and scientific advisory role in clinical development. Her professional experience spans a wide range of therapeutic areas of medicinal products, covering all aspects of drug safety monitoring and regulatory aspects of medicinal product life cycle.

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