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January 15th, 2016, 10:11 AM
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Join Date: Mar 2012
Re: Global Institute of Regulatory Affairs Mumbai

Advance P G Diploma in Drug Regulatory Affairs course is designed to give industry level education in field of legal and regulatory issues.

These issues are critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course also focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

Eligibility
Graduates in any stream of science are eligible to apply.
Final Year Students can also apply.

Course Objective
To make a thorough understanding of important regulatory concepts
To build experts in the field of RA documentation and research.
To make an entry platform in the field of RA for fresh graduates.
To assist students build their career in RA and become RA professionals.
To offer students with a global knowledge of Regulatory Affairs.

Course Structure
The Aims & Structure of Regulation
Regulatory Strategy
Marketing Authorization
Non – Clinical Studies
Clinical Trials
Good Manufacturing Practice (GMP)

Course Duration
Six Months Full Time Class Room Program.

Learning Outcome
Able to inscribe Regulatory Documents
Produce Regulatory Strategy
Acquire Marketing Authorization from different countries
Grow to be an RA professional

RA professional can get employment in following profiles:
Regulatory Affairs Associates
Regulatory Affairs Assistance
Regulatory Affairs head/ Director
Medical Information Associates
Drug Inspector/Drug Controller/
Drug Safety Specialist/ Regulatory Food Safety Scientist
Quality Operations/Quality Control/Quality Assurance
Regulatory Affairs Consultants

Contact Details:

Global Institute of Regulatory Affairs
Prestige Classic BLD, D Wing
Off G4 & 5, Chinchwad Station,
Near Dawabazar,
Chinchwad Pune -19
Tele - 020 - 46704472
Email - info@regulatoryinstitute.com


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