CENTRE FOR DRUG REGULATORY AFFAIRS

The centre commenced in the month of December 2016 with the following objectives:

- Convergence of industry and academia and becoming a think tank on drug regulatory affairs.

Course: Certificate Course on Generic Drug Regulations Drugs

Organised by: Centre for Excellence in Drug Regulatory Affairs, 

                         Manipal College of Pharmaceutical Sciences, MAHE, Manipal

About the Course: 

Drugs are the most regulated commodity Every stage of the life cycle of the drugs is governed by regulations and often they are country-specific India supplies generic drugs to more than 80 countries in the world It is known as “Pharmacy of the world” for the same reasons Indian Pharmaceutical industry employs a large number of non-pharmacy professionals who should know basic regulations governing the drug development, registration and marketing This course aims to create that basic understanding in the new professionals who are planning to have a professional career in the pharmaceutical, biotechnology and other related fields.

Scope

The course aims at creating an understanding of regulatory submission requirements for a generic drug, especially to USFDA.

Course Objective

1. Understanding the stages of regulatory control.

2. Regulatory forms and procedures of USFDA.

3. Hands-on training in Pharma Ready® an eCTD software.

4. Detailed content and requirements of USFDA form.

Course Duration: 15 hours

Credit: One

Course Fee: ₹ 4,000.00

Registration: https://sis.manipal.edu/CertificateCourses.aspx.

Dates: August 7th, August 14th and 28th  2021 (Following Saturdays)

Click here to download the brochure for further details.