Introduction to Regulatory Affairs for Pharmaceuticals

This introductory course provides a basic understanding of the regulatory processes for drug development, approval, and post-marketing surveillance. You’ll learn about key regulators and regulations in the EU and US, clinical trial approvals, drug registration, and compliance. Enhance your skills to ensure your pharmaceutical products meet global safety and efficacy standards.

This training has been developed by the experts at GBA Key2Compliance. The films are animated and designed to enhance understanding and perception of the presented concepts and are presented by AI generated speakers.

The training is divided into 2 modules: a general presentation and short exam. After the successful completion of both modules, you will receive your Certificate of Completion.

Content

• Key concepts and requirements in regulatory affairs for pharmaceuticals
• Important regulations and regulators in the EU and US covered by EudraLex, 21CFR 210 and 211 as well International Council on Harmonisation and international pharmacopoeia
• Regulatory interactions within the drug development process from preclinical to post market monitoring and reporting
• Overview on the Common Technical Document used for registration for marketing authorization or making changes post authorization

Duration: 46 minutes

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