EU Pharmacovigilance - Webinar CD/Transcript
EU Pharmacovigilance: Impact of the New Regulation
More than 15 significant new pharmacovigilance requirements have been introduced in the EU in the past year. Many changes will require drugmakers to make process changes and have prompted such questions as:
- 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?
For answers to these questions and more….
FDAnews and noted EU pharmacovigilance expert Elisabethann Wright of Brussels-based Hogan Lovells teamed up to provide an update on the status of pharmacovigilance in the EU.
In 90 minutes, Ms. Wright guides you through the most immediate changes and the layers of regulation to focus on the key requirements.
This is not taught in regulation-speak, or legalese. Ms. Wright provides listeners with real world and easy-to-use guidance that makes the regulations understandable.
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.