Audrey Aubert

Ensuring regulatory compliance is essential to guarantee that clinical trial supplies are manufactured, packaged, labelled, stored, and distributed safely and ethically. With frequent updates to global regulations, technological advances, and increasing complexity in clinical trials, keeping up with requirements has never been more challenging.

Join this session as our panellists share insights and practical guidance to help you stay ahead of regulatory changes while ensuring patient safety.

Key discussion points:

• Overview of the regulatory landscape for CTS: Explore key regulations affecting investigational medicinal products including EU CTR 536/2014, GMP Annexes 13 & 16, and GDP guidelines.
• Challenges of evolving regulations: Learn how to manage updates across multiple regions and adapt supply chain processes accordingly.
• Compliance strategies: Discuss implementing robust quality systems for packaging, labelling, storage, and distribution to ensure your clinical trial supplies remain inspection ready.