Advance P G Diploma in Drug Regulatory Affairs - Full Time

Learning outcome >> Career Opportunities >> Eligibility >> Study Material>> Admission Procedure

This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies.  The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

 

 

Course Objective

• To  create a thorough understanding of important regulatory concepts
• To create experts in the field of RA documentation and research.
• To create an entry platform in the field of RA for fresh graduates.
• To help students build their career in RA and become RA professionals.
• To provide students with a global knowledge of Regulatory Affairs.

Course StructureTop

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

Course DurationTop

• 6 Months Full Time Class Room Program.

Learning OutcomeTop

• Able to write Regulatory Documents
• Create Regulatory Strategy
• Get Marketing Authorization from different countries
• Become an RA professional

Career OpportunitiesTop

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.
The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products.  To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.

• Type of companies hiring RA professionals
• Pharmaceutical
• Medical Devices
• In Vitro Diagnostics
• Biologics and Biotechnology
• Veterinary Products
• Cosmetics
• Local FDA/ US FDA/UK MHRA/EDQM
• Ministry of Health/DCGI
• Clinical Research Organization/ Contract Research Organization
• Pharmaceutical consultancy companies

• RA professional can get employment as
• 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

EligibilityTop

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

Study Material Top

Study Material will be provided to the students. Students will also need to refer lot of Books and Journals.

Admission Procedure (Full time Students)

• Purchase the Admission Prospectus from GIRA office in Pune by visiting personally or call us at 020-46704472 and email at info@regulatoryinstitute.com

• Fill up and submit the same by prescribed date.

• Appear for Personal Interview on the date given.

• Pay the fees for admission before the prescribed date.

Apply Online

Students can register online by clicking here, please mention your mobile number and course interested . A representative will get in touch with you within 48 hours.