Navigating the Latest Revisions in GVP: Key Updates on Module XVI and Risk Minimization Measures
WEBINAR WILL BE RECORDED
WEBINAR DETAILS
About
Join us for an in-depth review of the latest updates to GVP Module XVI, with a focus on Risk Minimization Measures (aRMMs). This webinar will provide critical insights for Marketing Authorization 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.
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.
Q & A
Price
Free
Language
English
OPEN TO
Anyone with the event link can attend
Dial-in Number
Please register for this Webinar to view the dial-in info.
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....
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,...
PrimeVigilance, an Ergomed company, has grown to become the leading Pharmacovigilance specialist company, delivering global solutions for clinical safety and post-marketing pharmacovigilance and medical information from our operational hubs based...