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,
? ? ? ? ? ? ? ? ? ? ? ? ? 中国体育彩票app下载?College of Pharmaceutical Sciences, MAHE, 中国体育彩票app下载
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, 中国体育彩票app下载 College of Pharmaceutical Sciences, 中国体育彩票app下载 Academy of Higher Education, 中国体育彩票app下载.
Co-coordinator:?Dr Sudheer Moorkoth, Professor and Head, Department of Pharmaceutical Quality Assurance, 中国体育彩票app下载 College of Pharmaceutical Sciences, 中国体育彩票app下载 Academy of Higher Education, 中国体育彩票app下载.
?
Contact details
Dr C Mallikarjuna Rao
Professor and Principal
中国体育彩票app下载 College of Pharmaceutical Sciences (MCOPS)
中国体育彩票app下载 Academy of Higher Education, 中国体育彩票app下载 576104
Karnataka State, India
Email: mallik.rao@manipal.edu
?
Dr Krishnamurthy Bhat
Professor, Department of Pharmaceutical Quality Assurance
中国体育彩票app下载 College of Pharmaceutical Sciences (MCOPS)
中国体育彩票app下载 Academy of Higher Education, 中国体育彩票app下载 576104
Karnataka State, India
Email: km.bhat@manipal.edu
Phone: 0820 292 2482
?