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Regulatory Affairs

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Course type: Online Instructor led Course

Course ID: 18513

Course type: Online Instructor led Course

Students Interested 2 (Seats Left 0)

₹ 10,500

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Date and Time

Not decided yet.

Dr Kumud Sarin

PhD from Delhi University

About Dr Kumud Sarin

16 to 17 years academic experience
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About the Course

Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including Pharmaceuticals, Veterinary Medicines, Medical Devices, Pesticides, Agrochemicals, Cosmetics and Complementary Medicines. Most companies, whether they are major multinational Pharmaceutical Corporations or Small, Innovative Biotechnology Companies, have specialist departments of Regulatory Affairs professionals. The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. With the aim of providing training IBRI has launched the course in Regulatory Affairs with the mission to train students and professionals who can help the industry to work under regulatory environment

Topics Covered

IBRI course is different from other institutes and universities as its study material is based on recent trends and includes following topics:
Procedure for the documents submission e.g. DMF,/E-CTD, Dossier
Loan License ( Contract Manufacturer)
Hatch Waxmann Act; Bolar Provisions
Separate Description of Regulations for Biologics, Medical Device/Pharmaceutics
Recently globally included of regulations and Compliance systems of Australia, Brazil.
Biopharmaceuticals
Market Authorization, Audits and inspections.

Who should attend

Any Science Graduate or Having similar work experience

Pre-requisites

Need to be a science graduate

What you need to bring

Registration Form
Educational Certificate Documents Photo copies
Course Fees
Photograph

Key Takeaways

Certificate and Mark-sheet if qualify the final examination

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Students Interested 2 (Seats Left 0)

₹ 10,500

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