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Regulatory Affairs - Gratisol Labs

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

ELIGIBILITY:

A candidate seeking admission to the above programme must have passed bachelor degree in pharmacy or medical sciences. A candidate having bachelor Degree in any discipline with two years of experiences in Pharma industry will also be eligible.

SELECTION PROCEDURE:

To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:

  • Personal Interview
  • Screening And Selection Of Students

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.

For more information, please contact Gratisol Labs at info@gratisol.com

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