Risk Management Plans: GVP Module V Revision 2 and Its Local Impact in the EU, Upcoming Webinar Hosted by Xtalks

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Risk management plans in the EU have undergone significant changes to address the European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) Module V Revision 2. In this free webinar, an industry expert will share case studies to illustrate the critical differences resulting from Revision 2 and describe the implications of potentially removing risks from risk management plans. Pharmaceutical professionals will benefit from learning how Revision 2 to GVP Module V will affect nationwide drug approvals.

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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.

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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Contact:
Candice Tang
Tel: +1 (416) 977-6555 ext 400
Email: ctang@xtalks.com

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Candice Tang
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