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Struggling with Drug Regulatory Affairs (DRA)? This course is perfect for you! The pharmaceutical industry is heavily regulated to protect public health, aiming to develop safe, effective drugs while meeting strict standards. Regulatory professionals ensure compliance with country-specific rules, navigating complex processes like the USFDA’s rigorous drug submission system. This course simplifies the process, helping you avoid delays with key topics like: DRA basics and terminology Role and skills of a Regulatory Affairs professional USFDA rules and drug approval (IND, NDA, ANDA, etc.) History of U.S. drug laws Orange Book, Drug Master File (DMF), CTD, and eCTD GMP, clinical research, and BLA Regulatory strategy and key websites With over 30 short videos, downloadable resources, interview FAQs, and a bonus "Meeting Etiquette" mini-course, you’ll gain practical skills fast. By the end, you’ll be a more confident professional, ready to excel in DRA. What You’ll Learn: DRA essentials and why RA pros matter U.S. drug approval process and regulations Key tools like Orange Book, CTD, and eCTD How to research and strategize in DRA Tips to boost your career Requirements: Interest in drug development and DRA Basic English and internet access No prior pharma experience needed Who It’s For: Pharma employees, students, and career starters in DRA