Do you want to learn how to navigate the regulatory landscape in pharmaceuticals? Be introduced to complex and fascinating world of pharmaceutical regulation. You'll learn about the critical role regulatory affairs plays in ensuring the safety, efficacy, and quality of pharmaceutical products, from early drug development stages through post-market surveillance. We'll delve into the drug development process and explore the US FDA regulations and guidelines. By the end of this course, you'll have a solid understanding of the regulatory landscape, equipping you with the knowledge and skills needed for a successful career in the pharmaceutical industry.
Upon completion of this course, you will be able to:
- Analyze the roles and functions of the FDA and the agency’s impact on the pharmaceutical development process.
- Apply regulatory guidelines to various stages of drug development, ensuring compliance with safety, efficacy, and quality standards.
- Discuss the ethical and compliance issues in pharmaceutical regulation.
- Analyze case studies to understand regulatory strategies and decision-making processes.
Testimonials
"MBS has a great combination of classes like Regulatory Affairs where one can learn everything about how to file for a new drug application to the FDA process as well as learn about how to manage multiple projects through project management classes. I think this course has very well prepared me for the future challenges and gave me a hope to reach for the stars!" (Mansi Bengali, Biotechnology and Genomics, MBS'14)