Date of Event: March 7, 2024
Location: Virtual Event
8:00 AM or 11:00 AM Eastern Standard Time
Duration: 30 minutes
Since the 2023 relaunch of EMA's Clinical Data Publication Policy (EMA Policy 0070), clinical trial sponsors have seen a marked uptick in regulatory requirements for clinical document publication.
As these documents contain dense personal and commercially confidential information (CCI), protecting this information—through redaction or statistically derived transformation—can pose a significant challenge.
With public document disclosure becoming integral to the clinical trial lifecycle, you can reduce this burden by incorporating best practices in writing transparency-friendly clinical documents.
Join Niamh McGuinness, Associate Director, Safety, Regulatory & Transparency, to find out:
- What makes a clinical document transparency-friendly?
- How do you incorporate best practices into your current initiatives?
- How can our complete solution help you satisfy 3 key requirements - EMA Policy 0070, EU CTR, and Health Canada’s PRCI?
Sign up for either session (or both) to see a short presentation followed by a chance to ask your most pressing questions about EMA Policy 0070 and transparency-friendly clinical documents.
