This 2-day workshop will include background and current status of the requirements for PSURs, experience with meeting Regulators expectations, practicalities of document production, and consideration of anticipated developments in the field. It critically examines the PSUR content (including PSUR Addendum and Summary Bridging Reports) and process from the pharmacovigilance and medical writing perspectives.
BENEFITS OF ATTENDING - Understand the Background and Current Status of the Requirements for PSURs
- Discover How to Produce a High Quality PSUR & the Practicalities of Document Production
- Gain an Overview of Relevant Guidance Documents and the Differences between EU & US
- Ensure you Know How to Meet Regulators Expections
- Discuss Future Developments
