Drug Regulatory Affairs (DRA) Certificate Course, A complete guide to drug regulatory affairs DRA, approvals, clinical trials, CTD, eCTD and global regulatory frameworks..
Course Description
Are you ready to navigate the complex world of drug regulatory affairs (DRA )with confidence?
This comprehensive course is designed for pharmaceutical professionals, regulatory beginners, and life sciences graduates who want to understand the entire regulatory landscape—from drug development to post-marketing surveillance.
You’ll explore global authorities like the FDA (USA), EMA (EU), MHRA (UK), PMDA (Japan), and more. Gain a clear understanding of ICH guidelines, Good Clinical Practice (GCP), Common Technical Document (CTD) and electronic submissions (eCTD). Dive deep into clinical trials, labeling regulations, pharmacovigilance, regulatory compliance, and audit readiness.
Whether you’re planning a career in regulatory affairs or want to upskill for a promotion, this course provides the technical depth and real-world insights needed to excel in any regulatory role.
By the end of this course, you will be equipped to:
- Prepare and manage regulatory submissions (NDA, ANDA, BLA, MAA)
- Understand the full drug development and approval process
- Respond to queries from regulatory agencies
- Ensure compliance with international regulations
- Navigate post-approval requirements and safety reporting
Through real-world examples, visual slides, and simplified explanations, you’ll gain the clarity and confidence needed to work in or transition to a regulatory role.
Whether your goal is to join a regulatory affairs team, contribute to product submissions, or simply understand how drugs get to market, this course is your stepping stone.
Enroll now to master the knowledge and practical skills essential for success in the fast-evolving world of regulatory affairs.
https://www.udemy.com/course/drug-regulatory-affairs-dra/?couponCode=90FDB2CB818B0AC147F3
