Add on Certification
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.
Features of the course
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 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-
Executive Program in Global Drug Regulatory Affairs
Executive Program in Global Drug Regulatory Affairs provides comprehensive training on drug regulatory affairs. A uniquely designed self paced training covers General Drug Regulatory Affairs and also Regional Drug Regulatory Affairs in a single bridged program. Therefore, one can get the entire knowledge of Regulatory Affairs.
General Drug Regulatory Affairs
- Fundamental to Drug Discovery Development to Commercialization
- Clinical Research – Advance Learning
- IPR strategic planning – Patent, Trademarking. Patent and trademark filing, registration, objection, opposition handling process. Patent Term Extension, Patent Term Restoration.
- Marketing Authorization Process and strategic pathways for pharmaceuticals, Biopharmaceutical products.
- Generic Drug and Innovator Molecule’s Marketing Authorization Process
- ANDA preparation and filing – ANDA submission, Para IV filing, first to file.
- Portfolio Management – case based learning – Training on Loss of Exclusivity Management, Evergreening tools and techniques. Various strategic planning.
- GMP – GMP training, GMP Audits, 483 observations, warning letter, data integrity, SOP Management, CAPA
- Stability study – Requirements, types of stability study, management of stability studies and requirements.
- Variation Management – Authorization management, regional differences.
- DMF preparation and filing, SMF preparation and filing
- Drug Dossier Preparation, filing and management of the dossier for different product classes.
- Advance training on biopharmaceutical – innovator and biosimilar regulatory pathway
Regional Drug Regulatory Affairs
- US FDA Drug Regulatory Affairs
- European Regulatory Affairs [Post Brexit]
- Middle East + GCC countries regulatory affairs
- ASEAN drug regulatory affairs
- African drug regulatory affairs
- LATAM drug regulatory affairs
- BRIC – Brazil, Russia, China, India, drug regulatory affairs.
|Study Module – [Downloadable E-book]||18 no.||You can download, save and print for offline study.|
|E-lectures||230 sessions||Each session of 1 hour – 5 hour duration|
|Handout of Electures||Yes||You can download and save.|
|GMP Audit Format||170 Pages exclusive GMP audit format||Open file, you can modify and use for own purpose|
|Dossier Format||Actual dossier [open .word format] of 160 Pages open file will be provided.||You can download and use for own purpose.|
|Final Examination||Online, MCQ type||You can schedule your final examination at your convenience.|
|Course complete certificate||Yes||You can request only after 4 month of the completion of the course.|
|Final examination result and gradation certificate||Yes||Will be issued within 48 hours after completion of the final examination.|
View comparison of 1 Week / 1 month / 1 Year program Drug Regulatory Affairs course content comparison. This will help you to select the right regulatory affairs program.
- The participants of Global Business Registrant will get one add on certification.
- Participant can choose add on courses of any 1 month or 1 week certification course.
- There will be no fees for add on courses and courses can be opted any time during the main course access period.
- On completion of add on course, participant will be issuing course certificate.