Advanced Certified Program In Regulatory Affairs

The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the inter phase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products.

Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs’ department. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment.

Program Objectives

The major objective of this course is to provide an interdisciplinary knowledge of pharmacy and law as applicable in the field of pharmaceutical regulation at National and International levels. The course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export-import agencies dealing with the pharmaceuticals.

The focus of the lectures is mainly on:

• Introduction to Clinical Research

• Preparations & Planning for Clinical Trials

• Introduction to Regulatory Affairs

• Global Regulatory Environment

• Pharma Regulations Practices & Procedures

• Import and Export of Drugs in Global Pharmaceutical Industry

• Common Technical Document

• Good Manufacturing Practice

• Quality Assurance and Regulation

• Regulatory Aspects in Pharmacovigilance

• Regulations Governing Clinical Trials & New Drugs

• Global Drug Policy

• Essential Documentation in Clinical Research & Regulatory Submissions

• Clinical Trials Project Planning & Management

• Study Start Up Process

• Clinical Monitoring Essentials

• Compliance, Auditing & Quality Control in Clinical Research Program