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
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 the “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 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 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
Timings: 09.30 am – 04.00 pm
Dates: August 7th, August 14th and 28th 2021 (Following Saturdays)
Credits: One
Registration: https://sis.manipal.edu/CertificateCourses.aspx
Last Date: August 1, 2021
Click here to download the brochure for further details.
Coordinators
Coordinator: Dr Krishnamurthy Bhat, Professor, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal.
Co-coordinator: Dr Sudheer Moorkoth, Professor and Head, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal.
Contact details
Dr C Mallikarjuna Rao
Professor and Principal
Manipal College of Pharmaceutical Sciences (MCOPS)
Manipal Academy of Higher Education, Manipal 576104
Karnataka State, India
Email: mallik.rao@manipal.edu
Dr Krishnamurthy Bhat
Professor, Department of Pharmaceutical Quality Assurance
Manipal College of Pharmaceutical Sciences (MCOPS)
Manipal Academy of Higher Education, Manipal 576104
Karnataka State, India
Email: km.bhat@manipal.edu
Phone: 0820 292 2482