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Basic Course in Drug Regulatory Affairs

(7 customer reviews)
Created by: Dr Pravin Badhe Release Date: Rating: 4.2

This course is intended to provide students with a comprehensive overview of the drug regulatory affairs field. The regulatory environment for drug development and approval is complex and highly regulated, and it is essential for those working in the pharmaceutical industry to understand the key principles and requirements.

Throughout the course, students will learn about the regulatory framework for drug development, including the various phases of the drug development process, from preclinical studies to clinical trials, and the importance of good clinical practice. They will also gain a thorough understanding of regulatory submissions, including the new drug application (NDA) and abbreviated new drug application (ANDA), as well as the importance of regulatory strategies for pharmaceutical products.

In addition to regulatory submissions, the course will cover post-approval requirements and lifecycle management, including quality assurance and good manufacturing practices (GMP), pharmacovigilance and drug safety, and compliance and inspections in drug regulatory affairs. Students will also learn about the various regulatory agencies involved in drug approval, such as the Food and Drug Administration (FDA), and the guidelines and regulations they follow.

Finally, the course will explore global regulatory affairs and harmonization and the future trends and challenges in drug regulatory affairs. By the end of the course, students will have gained a comprehensive understanding of the drug regulatory affairs field and will be well-equipped to navigate the complex regulatory environment of drug development and approval.


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