Drug Regulatory Affairs course provides practical knowledge and hands on training on drug regulation and registration process. This course is online self paced. Hence, one can attend the course 24×7, based on own convenience.
Career in Drug Regulatory Affairs
A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.
The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EMEA, and other national regulatory agencies, all over the world are imposing number of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.
Our Registerants are in Takeda, Pfizer, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, 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, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.
- 24×7 self paced online learning. Hence, you can access the course 24×7 based on your convenience.
- Pintable booklet provided to all course participants. There will be total 18 books will be provided. Refer syllabus copy to view the details.
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage.
- Flexible online final examination (Computer Based Test by secure mode)
- Course features real-life case based learning. Therefore, it provides the job related exposures.
B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.
Course Deliverable – Regulatory Affairs advanced program
|Study Module – [Downloadable E-book]||18 no.||You can download, save and print.|
|E-lectures||190 sessions||Each session of 1 hour – 5 hour duration|
|Handout of Electures||Yes||You can download and save.|
|GMP Audit Format||170 Pages exclusive audit format||Open file, you can modify and use for own purpose|
|Dossier Format||Sample dossier of 160 Pages open file will be provided.||You can download and use for own purpose.|
|Final Examination||Online, MCQ type|
|Course complete certificate||Yes||You can request only after 4 month of the completion of the course.|
|Course examination result and gradation certificate||Yes||Will be issued within 48 hours after completion of the final examination|
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