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Pharmaceutical Drug Regulatory Affairs
This course provides an overview of the regulatory requirements and processes for pharmaceutical drug development, manufacturing, and marketing. Students will learn about the regulatory agencies, laws, and guidelines that govern the pharmaceutical industry.
Course Outcomes:-
1. Understand the regulatory framework governing pharmaceutical drug development, manufacturing, and marketing.
2. Familiarize with the structure and function of regulatory agencies such as FDA, EMA, and ICH.
3. Learn about the regulatory requirements for pharmaceutical drug development, including nonclinical and clinical studies.
4. Understand the principles of good manufacturing practice (GMP) and good laboratory practice (GLP).
5. Familiarize with the regulatory requirements for pharmaceutical drug labeling, advertising, and promotion.
6.Learn about the regulatory requirements for post-marketing surveillance and pharmacovigilance.
7.Understand the principles of regulatory compliance and the consequences of non compliance.
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