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.
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
Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here
Over the last 12 years PharmaSchool has provided a free weekly GCP & Clinical Research related challenge. With nearly 3 quarters of a million attempts at these Challenges they are used across the World to test, learn and document knowledge.