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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.
Lesson 1: An Introduction to The Pharmaceutical Industry
Lesson 2: An Introduction to Good Manufacturing Practice (GMP)
Lesson 3: What Is the Difference Between GMP and CGMP?
Lesson 4: Regulations in EU
Lesson 5: Safety Monitoring of Medicines
Lesson 6: What are GMP Standards?
Lesson 7: Regulations and Guidelines of EU GMP
Lesson 8: Compliance with GMP in EU
Lesson 9: Robust Regulatory Framework and Scientific Expertise in the EU