One of the most important aspects of this update is the possibility to remove risks from RMPs, provided that it can be demonstrated to the authorities that these are adequately managed.
TORONTO (PRWEB) January 16, 2020
Module V of GVP, which governs Risk Management Plans (RMPs) and Systems, has gone through a significant overhaul with its second revision. One of the most important aspects of this update is the possibility to remove risks from RMPs, provided that it can be demonstrated to the authorities that these are adequately managed. This issue does not always arise with central authorities like the EMA but can affect approvals of local EU authorities as well.
Join Dr. Kosta Cvijovic, EU QPPV from Syneos Health, the only fully integrated biopharmaceutical solution organization, on Thursday, February 6, 2020 at 9am EST (2pm GMT/UK) for a live webinar where attendees will hear:
- An overview of the current Module V of the GVP
- A review of changes resulting from Revision 2
- Exploration of practical applications of Module V through case studies, both when it comes to interactions with the EMA and ANSM
- Discussion of Benefits and challenges of risk removal and/or adaptation
- A review of changes to the modular system of the GVP documents
Special focus will be put on data and arguments for risk removal and/or adaptation, the success rate of such an approach, as well as the change in the modular system of the GVP documents which no longer necessarily makes Periodic Safety Update Reports’ (PSURs’)/Periodic Benefit-Risk Evaluation Reports’ (PBRERs’) and RMPs risk sections fully exchangeable.
For more information or to register for this event, visit Risk Management Plans: GVP Module V Revision 2 and Its Local Impact in the EU.
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