Maintain EU-CTR compliance: Guidance on the first substantial modification after slim transition and ongoing strategic information management
As the EU-CTR transition period concludes, we now focus on studies that were transitioned with a slim dossier and have pending requirements to fulfill. To ensure ongoing compliance with the regulations, including actions related to the first substantial modification (SM), we invite you to join Parexel’s regulatory expert-led live webinar.
Using practical scenarios to guide the audience, our speakers will discuss the implications of non-compliant dossiers and explore best future practices for managing submission content and prioritization.
What you will learn from the webinar:
- Requirements for studies to comply with EU-CTR, post slim transition
- Recommendations for prioritization and grouping of information within the first SM after transition
- Strategic information management approaches for new and ongoing trials
- Practical advice gained from experience of more than 250 trial transitions
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