Description
- Welcome to our comprehensive online (In-class) course and self-paced learning, this course offers a holistic learning to clear Regulatory Affairs Certification in drugs exams (RAC-Drugs) RAPS, equipping you with invaluable knowledge for success in this evolving field, covering a spectrum of critical topics in
- Full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products.
- US FDA requirements (30%).
- European regulations and guidance’s from the European Commission, EMA, and competent authorities (30%).
- Globally applicable regulatory practices* (40%). (*ICH, and WHO guidelines and standards).
- Critical thinking and analytical skills.
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