CMC Regulatory Affairs - EU/US Differences


Our client had regulatory affairs and production staff on both sides of the Atlantic. Each group was expert in its own geographical area but each wanted to improve their understanding of the requirements in the other region, in order to optimise the provision of high quality registration documentation.

Course Outline

Day 1

1. The Regulatory Authorities in teh EU and US
2. Module 3 - EU/US Differences
3. Drug Master Files and Certificates of Suitability
4. Teamwork Exercise - Data Requirements for EU/US files
5. Manufacturing Authorisations and the Role of the QP

Course Description

This course covered the pharmaceutical legislation and guidance as it relates to CMC issues in Europe and the US, comparing the two regions. GMP and inspection differences were also addressed as well as the requirements for post-approval amendments.

Day 2

1. EU and US GMP Regulatory Issues and Requirements
2. FDA Pre-approval Inspections
3. Regulatory Compliance - EU and US Variations and Amendments
4. Teamwork Exercise - Post Approval Change Strategies

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Albany Park, Camberley
Surrey. GU16 7PL

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