Course Code: KPE-C-103
Course Title: Executive Program in Global Drug Regulatory Affairs [EPGDRA]
Executive Program in Drug Regulatory Affairs courses are conceptualized with vision to create effective Regulatory Affairs Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Regulatory Manager with practical exposure.
Our Registerants are in Lipoxen (UK), Orchid, Sanofi-Aventis, Astra-Zeneca, Hospira, Ranbaxy, Julphar, J&J-Ethicon, Pfizer, DRL, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Shaigan Pharmaceuticals, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Winatac Limited, Faveo Pharmaceuticals, Enzem, Leo, Accenture, Mylan, and many more companies across the pharma industry.
1. Printable study modules [PDFs] provided to all course participants. There will be total 28 study modules. Refer syllabus copy to view the details.
2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage.
3. Flexible online final examination (Computer Based Test by secure mode)
4. Access to 1000s of real life case studies
B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or Phd holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. Minimum 2 years experience required for admission.
Executive Program in Global Drug Regulatory Affairs will be focusing on following-
- Fundamental to Drug Discovery Development to Commercialization
- Clinical Research – Advance Learning
- IPR strategic planning – Patent, Trademarking
- Regulatory Strategic Planning
- GMP – GMP Audits, 483 observations, data integrity, SOP Management, CAPA
- DMF preparation and filing
- SMF preparation and filing
- ANDA preparatopn and filing
- Drug Dossier Preparation
- Advance training on biopharmaceutical – innovator and biosimilar regulatory pathyway
- Portfolio Maangement – case based learning
- Regional DRA
- European Regulatory Affairs [Post Brexit]
- GCC Regulatory Affairs
- ASEAN drug regulatory affairs
- African drug regulatory affairs
- LATAM drug regulatory affairs