Overview

Pharmaceutical and Medical device companies rely on the regulatory affairs department for ensuring that their products comply with the laws, guidelines, and other regulations in the industry. The regulatory affairs department of an organization makes it certain that the products are developed, manufactured, and regulated at desired level of quality safety and efficacy. They set up strategies and uses their scientific and management skills to achieve a goal of quality assurance throughout the lifecycle of a medicinal product. The RA team ensure meeting the standards of filing and submissions along with contributions towards to quality assurance and clinical affairs. Over the years the standards of regulatory affairs of pharmaceutical and medicinal products had a rapid advancement with the transitions in technology and pharmacovigilance. This specialization will provide you an overview of Regulatory affairs in Pharmaceutical and medicinal devices.

Key Highlights

1. Fundamentals of Regulatory Affairs
2. Introduction to Regulatory Bodies
3. Introduction to Quality Standards for Regulatory Compliance
4. Marketing, import and export guidelines on Pharma and healthcare products
5. Drug registration Procedures/ Channels in Europe
6. Drug registration Procedures in India
7. Compliance guidelines

Program Fees
Fees: Rs. 5500/- (Including GST)

Program Schedule

August 2022
Online Zoom platform

Program Directors:

Dr. Subodh S Satheesh
Assistant Professor, IIHMR, Bangalore.

Mr. Mrinmoy Roy
Assistant Professor, IIHMR, Bangalore.