GIRA

Global Institute of Regulatory Affairs

An ISO 9001-2008 Institute

Post Graduate Program in Regulatory Affairs – Distance Learning

Fee Structure >> Learning outcome >> Career Opportunities >> Eligibility

The course is designed for students and industry professionals who have little or no knowledge in regulatory affairs. This course will help them understand the fundamental and concepts of regulation prevailing in various countries. It will enhance their knowledge and skills in the field of RA.An RA skilled professional can work in various departments as RA knowledge is diversified and useful to both international marketing professionals as well as QA /QC personnel. Apart from that they have their own department also called RA department where they focus mainly on Marketing Authorization approvals from various countries and in house documentation.

Course Objective

    • To  create a thorough understanding of important regulatory concepts
    • To create experts in the field of RA documentation and research.
    • To encourage continuous learning and development in RA field..
    • To clear the basic fundamentals of RA .
    • To update knowledge of existing RA professionals.

Course StructureToptop

Course MethodologyToptop
  • This is a Distance learning Program – where students participate by filling necessary forms and paying the fees.
  • Introduction Kit is delivered to participants of the program – this kit will contain study material and all necessary information about the program with important dates
  • The Participant is required to complete a Project on an allocated topic during the term of the program, these reports have to be submitted by prescribed dates.
  • The Participant will be able to interact with other program participant through the use of online blog. Each participant will be given a unique User ID and password for the same.
  • Participants will be evaluated based on project submitted & final examination held at the end of the term.
  • The participant will be able to share their views and ask question in the blog openly, this blog will be monitored by RA experts to answer any queries or doubts apart from that timely news and development will also be updated over there.
  • Student will also be able to participate in seminars conducted by GIRA periodically - Extra fees

Fee StructureToptop

COURSE NAME
DURATION
FEES
PG Diploma Regulatory Affairs (Distance Learning)
10 months course – Distance Learning Course
Rs. 15,000 -/-

Learning outcomeToptop
    • Understand Regulatory Concepts
    • Able to write and review Regulatory Documents
    • Marketing Authorization from different countries
    • Become an RA professional
    • Preparation for audits and inspections
    • Advance to an higher level in RA career ladder

Career OpportunitiesToptop

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
EligibilityToptop
  • Graduates in any stream of science are eligible to apply.

Apply OnlineToptop

Student s can Download the admission form by clicking here, in PDF format print and fill the same, clearly mentioning Mobile No & Course Interested.The Filled form should be courried to us along with DD at the below mentioned address.

Attn: Sumit Gupta
Global Institute of Regulatory Affairs
Empire Estate, Shop NO C 5 & 6,
Mumbai Pune Highway,
Chinchwad Pune – 19
Tele – 020-46704472


Our  Courses
one  Full time course
It is designed for - Final Year graduate, recently graduated students who are in the beginning or looking to begin their career in the Pharmaceutical sector...
sa  Part time course
It is designed for working professionals who are looking to add to their existing knowledge and skills. .
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Testimonial
"GIRA distance learning program in RA is a well balanced, highly innformative and excellent learning experiene." - Sachin Bhatnagar ( RA officer at MNC)
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