Master the field of global regulatory affairs, compliance, guidelines, submissions and audit readiness tools
Sub Category
- Science
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Objectives
- Enhance career prospects in the pharmaceutical industry by mastering regulatory compliance and cross-functional collaboration.
- Master the essentials of Drug Regulatory Affairs, including USFDA, EMA, and ICH guidelines for drug development, compliance, and market approval.
- Develop strategic regulatory plans and risk management strategies to support pharmaceutical product lifecycles.
- Navigate key regulatory processes like CTD/eCTD, IND, NDA, ANDA, and BLA for efficient dossier preparation and submission.
- Apply GMP, GCP, and pharmacovigilance principles to ensure manufacturing, clinical, and post-marketing compliance.
- Prepare confidently for regulatory affairs certification exams with practical insights into submissions, inspections, and authority interactions.
Pre Requisites
- This beginner-friendly course is designed to make Drug Regulatory Affairs accessible to all learners. No prior experience is required, though the following can be helpful
- Curiosity and eagerness to learn about regulatory compliance, drug development, and pharmaceutical regulations.
- Whether you are new to the field or seeking to advance your career, this course provides all the tools and knowledge needed to succeed in regulatory affairs.
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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