EU Pharmacovigilance Impact of the New Regulation
Product Details
- How is the newly formed PRAC operating?
- What impact will the new PRAC, Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report (PSUR/PBRER) and Risk Management Plan (RMP) requirements have on your operations?
- How will changes in the legislation affect the way product assessment is carried out in both pre- and post- authorization phases?
- How will CMDh and other committees interact with the PRAC?
- Will the black symbol requirements radically change your product information processes?
FDAnews and noted EU pharmacovigilance expert Elisabethann Wright of Brussels-based Hogan Lovells have teamed up to provide an update on the status of pharmacovigilance in the EU.
In 90 minutes, Ms. Wright will guide you through the most immediate changes and the layers of regulation to focus on the key requirements.
This will not be taught in regulation-speak, or legalese. Ms. Wright will provide attendees with real world and easy-to-use guidance that makes the regulations understandable.
Mark your calendar now for this important 90-minute webinar on Tuesday, Sept. 25. It couldn’t be easier to attend: simply make sure you’re in front of a screen at the appointed time, and you’ll benefit from all the great advice in EU Pharmacovigilance without having to leave your workplace.
Everyone in your organization with a role in pharmacovigilance — clinical safety, medical affairs and regulatory affairs — should take part in this event and they can do so at a cost that won’t break the budget. You pay a single low registration fee per phone line, regardless of how many participate. So spread the word.
Have questions? Simply submit them online during the event or via email for answers by the time the session ends.