Fact Sheet | Staying Compliant in Complexity: A Guide to Clinical Trial Supply Regulations

Fact Sheet |  Staying Compliant in Complexity: A Guide to Clinical Trial Supply Regulations

Navigating the evolving landscape of clinical trial supply chain regulations is a continuous challenge for pharmaceutical companies, CROs, and solution providers. With shifting compliance requirements across the EU, UK, and US, staying ahead of regulatory updates is essential for seamless trial execution and patient safety.

This Fact Sheet breaks down the complexities of global clinical trial supply regulations, providing actionable insights to help CTS professionals mitigate risks, ensure compliance, and build resilient, patient-centric supply chains and includes expert insights from Kamal Amin, Head of Supply Management, Galderma and Steven Jacobs, President, Global BioPharm Solutions, LLC.

Download to learn more about:

  • Regulatory Updates & Compliance: Understanding the latest changes in GDP, GMP, EU CTR, ICH E6 (R3), MDR, post-Brexit UK regulations, and FDA guidelines.
  • Risk Mitigation Strategies: Identifying potential regulatory risks and implementing proactive compliance measures.
  • Supply Chain Resilience: Developing strategies to enhance flexibility and stability in an evolving regulatory environment.
  • Sustainability in Clinical Supply: Exploring global initiatives to integrate sustainability into supply chain operations.
  • Patient-Centric Supply Chains: Ensuring timely and compliant delivery of trial materials to improve patient outcomes.

Stay informed and prepared—download this fact sheet today to optimise your supply chain strategy in an increasingly complex regulatory environment.