Addressing Unique Challenges in Radioactive Material Compliance to Harmonize Global cGMP Standards & Enhance Regulatory Confidence for Drug Approval
Time: 1:05 pm
day: Pre-Conference Workshop Day
Details:
Navigating differing U.S. and European regulations is increasingly challenging. This workshop explores how regional GMP requirements affect manufacturing and supply chains, offering strategies to align compliance globally. Learn how early collaboration with regulators can speed up clinical supply approvals and international market entry.
Join this workshop to:
- Uncover the regulatory differences affecting manufacturing and supply chain across regions, particularly in Europe and the U.S.
- Discuss strategies to harmonize compliance practices for providing clinical supply, with a focus on how cGMP requirements for radiopharmaceuticals differ due to concerns around radiological safety, dose consistency, and product stability.
- Identify partnerships with regulatory experts to better navigate international approval processes.
