1. Approved by Quality Council of India (QCI), Government of India
Post Graduate/ Executive Diploma in
Pharmaceutical Regulatory Affairs
Approved and Certified by Quality Council of India, Government of
India
Institute of Good Manufacturing Practices India
B-271, Chattarpur Enclave Phase-2, 100 Feet Road,
Chattarpur, New Delhi-110074 (India)
Telephone: +91 8130924488,+91 11 65353339
Website: www.igmpiindia.org
E-mail: info@igmpiindia.org

2. About IGMPI
Institute of Good Manufacturing Practices India, registered as a non-profit society
with Government of India and a member (as a higher/professional Education
Institute) of Quality Council of India(QCI)-which is an autonomous body and an
accreditation authority for education & vocational training providers under the
Department of Industrial Policy & Promotion, Ministry of Commerce & Industry,
Government of India -presents unique, friendly and interactive platform to get rid
of all your GMP related glitches. Based on high standard of quality, the training
programmes in Pharma and healthcare GMP, Quality Assurance and Quality
Control, Regulatory Affairs, IPR, Pharma Product Management etc. have been
approved and certified by Quality Council of India.
Website: www.igmpiindia.org Email: info@igmpiindia.org

3. IGMPI Work Ideology
IGMPI’s work ideology remains
“When outcome matters wise integration of
knowledge and technology becomes essential to
promote best results.”
Website: www.igmpiindia.org Email: info@igmpiindia.org

4. Regulatory Affairs: Its importance
creates its need!
Regulatory affairs (RA) is a comparatively
new profession which developed from the
desire of governments to protect public
health by controlling the safety and efficacy
of products in areas including
pharmaceuticals, veterinary medicines,
medical devices, pesticides, agrochemicals,
cosmetics and complementary medicines.
Pharma regulatory affairs personnels play a
crucial role in assuring that all
pharmaceutical products are compliant with
regulations governing the industry. They are
the intermediate connection between the
pharmaceutical industry with the world
wide regulatory agencies.
Regulatory
Affairs
Regulatory
Submission
Technical &
Scientific
writing
Advertising
and
Promotion
Regulatory
Intelligence
Website: www.igmpiindia.org Email: info@igmpiindia.org

5. Course Modules
Module 1: Introduction to Global Regulatory Authorities for pharma and healthcare industries
Module 2: Drug Development Process, Clinical Trials and related norms and regulations
Module 9: Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach
reports
Module 7: Pharma and Healthcare industries IPR, Patents, Copyrights and Trademarks
Module 5: Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 3: GMP and other good practices
Module 10: Industry specific case studies
Module 8: Pharma and Healthcare products- Marketing, Import and Export regulations
Module 6: Dossier preparation in CTD format, eCTD submissions
Module 4: Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan,
Canada, Australia, South Africa, etc.
Website: www.igmpiindia.org Email: info@igmpiindia.org

6. About Programme
Eligibility: Any Graduate/ Post graduate/ PhD (Post Graduate Diploma)
Any working professional with 6 months of experience
(Executive Diploma)
Post Graduate Diploma in Regulatory Affairs: 12 months (Regular/ Distance)
Executive Diploma in Regulatory Affairs : 6 months (Part-time/ Distance)
Fees:
Regular: Rs 1,35,000 /- Programme fee, Rs 3,000/- Examination fee.
Part-Time: Rs 70,000 /- Programme fee, Rs 3,000/- Examination fee.
Distance cum e-learning: Rs 14,000/- Programme fee, Rs 300/- per module
Examination fee.
Website: www.igmpiindia.org Email: info@igmpiindia.org

7. Objective of the Programme
•To provide students with RA specific Knowledge and
understanding of execution aspects of regulatory guidelines.
•To familiarize participants with on-going trends and guidelines
for the varied sectors of the industry (drugs, food, beverages,
biotech, cosmetics etc.)
•To provide knowledge of Inter-state deviations in rules and
challenges of the industry.
•To provide complete information regarding history of regulations
and regulatory bodies.
Website: www.igmpiindia.org Email: info@igmpiindia.org

8. •To provide participants with in-depth knowledge and up-to-date
understanding of concept of generic drug and innovator, drug
discovery and development, Regulatory strategy, approval process
of all regulatory filings in various countries.
•The course also provides the knowledge of filling of information
regarding new drug development, manufacture, control, stability
studies, packaging, labeling etc. with regulatory agencies in a
prescribed format.
Website: www.igmpiindia.org Email: info@igmpiindia.org

9. Professional course in RA is
like one arrow with many
possible hits.
Regulatory affairs professionals have the kind of knowledge which suits many
highly regarded and important roles in the industry. A regulatory affair is
important but at the same time most dynamic job area in the healthcare
industry. After completing this course, the student can work as:
•Regulatory Affairs Officer
•Regulatory Affairs Associate
•Regulatory Affairs Specialist
•Manager in Regulatory Affairs department
•Regulatory Submission Specialist
The students can ensue their career in Pharma, Healthcare, Ayurvedic,
Homeopathy, Food manufacturing or any related industry.
Website: www.igmpiindia.org Email: info@igmpiindia.org

10. Placement Assistance
Professional resume writing
Providing interview skills
Conducting mock interviews
No extra fee for placement programme
Associated with many Pharma and Healthcare
industries
Website: www.igmpiindia.org Email: info@igmpiindia.org

11. Participation from the Industry
In recent months the Institute has witnessed more and more participation from
professionals working with
Website: www.igmpiindia.org Email: info@igmpiindia.org

12. Website: www.igmpiindia.org E-mail: info@igmpiindia.org
Other Programmes IGMPI Offers
Post Graduate and Executive Diploma in Pharmaceutical:
Good Manufacturing Practices
Quality Assurance & Quality Control
Intellectual Property Rights
Clinical Research
Good Laboratory Practices
Product Management
Nanotechnology
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13. Thank You
For more details/counseling, you can call/write us: at +91 8130924488,
+91 11 65353339 & programmes@igmpiindia.org