Peter Sas

Navigating Packaging Waste Reduction: From Compliance to Practical Implementation

Packaging waste represents a significant environmental and regulatory challenge. Compliance with regulations, such as EU Directive 2025/40, can be complex due to the number of rules, varying responsibilities across countries, and the inclusion of both local and imported packaging. Pharma companies must navigate overlapping directives, interpret detailed legal requirements, and ensure that internal operations and vendor practices align with these regulations. This session will explore practical strategies to reduce packaging waste while addressing these complexities.

Key Talking Points

• Regulatory Awareness – Understand EU Directive 2025/40 and related regulations
• Operational & Vendor Management – Discover how compliance affects internal processes and educate vendors to ensure alignment and accountability.
• Practical Implementation – Explore how to map packaging types, track regulatory obligations, and define responsibilities for disposal and recycling. 

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.