Duration: 1 or 2 days

Description:

This course covers the basics of clinical research and the differences in GMP requirements between commercial medicinal product and Investigational Medicinal Product.

Who it is suitable for:

This course is most suitable for those directly involved in packaging, labelling and shipping IMP.

Content:

Overview of Drug Development Process and phases of clinical trials

• Clinical Trial Process
• Overview of clinical trial lifecycle and key milestones
• Key people – roles and responsibilities
• Dosage Forms & Comparators (Placebo/Active)
• Clinical Trial Design – cross-over vs parallel group studies and implications for IMP
• Randomisation and Blinding of IMP’s
• Critical Implications and Risk Analysis

Current GMP for IMPs and GCP

• Eudralex Vol 4, Annexe 13
• Manufacturing licenses
• Import Regulations
• Special considerations for manufacturing/packaging of IMPs
• Packaging Designs – Primary & Secondary
• Labelling requirements and reconciliation
• QC/QA checks and sample retention
• Packaging instructions
• Distribution Considerations – Cold Chain & Ambient.
• Roles Responsibilities/QP
• Recalls, returns and destruction
• Relabeling
• Documentation
• Reconciliation
• Accountability
• IMP release requirements