An Introduction to Good Manufacturing Practices in the EU

Starting with the foundation of the pharmaceutical industry which has powerful representation in Europe, this course highlights the importance of Good Manufacturing Practice (GMP) in ensuring that food, health, and cosmetic products are safe and effective for use. The evolution of the concept to include Current Good Manufacturing Practice (CGMP) and Good Automated Manufacturing Practice (GAMP) which employ up-to-date procedures and automated technology respectively points to the progressive nature of the pharmaceutical industry and its regulatory agencies in the European Union (EU).

In this course, we provide a synthesis on the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Lesson 1: An Introduction to The Pharmaceutical Industry

• EFPIA – The Industry’s Parent Organization
• Small, But Giant
• Europe as a Centre for R&D
• The Importance of R&D in the Pharmaceutical Sector
• EU Trade of Pharmaceuticals and The Global Value Chain
• Analysis of The Major Trade Issues for the European Pharmaceutical Industry

Lesson 2: An Introduction to Good Manufacturing Practice (GMP)

• The 5 Components of GMP

Lesson 3: What Is the Difference Between GMP and CGMP?

Lesson 4: Regulations in EU

• The role of EMA
• National Competent Authorities
• Authorization and Supervision of Manufacturers

Lesson 5: Safety Monitoring of Medicines

• Clinical Trials
• International Cooperation

Lesson 6: What are GMP Standards?

• What is GAMP?
• What is Computerized System Validation?

Lesson 7: Regulations and Guidelines of EU GMP

Lesson 8: Compliance with GMP in EU

• COVID-19 Vaccines: Development, evaluation, approval, and Monitoring in EU

Lesson 9: Robust Regulatory Framework and Scientific Expertise in the EU

• Scientific Evaluation and Approval Processes
• Accelerated Evaluation
• Standard Monitoring
• Large Scale Monitoring in the Pandemic Context

Conclusion

Final Examination

Certification