Post Graduate Diploma in Regulatory Affairs IPR and Patent

Global Institute of Health Science
Distance

Rs 28,000
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Important information

  • Post Graduate Diploma
  • Distance learning
  • Duration:
    Flexible
  • When:
    Flexible
  • Credits:
  • Delivery of study materials
  • Support service
Description

Regulatory affairs (RA), also called government affairs, are a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs also have a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Global regulatory agencies are as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA).

If you have any questions or doubts, ask for more information through Emagister's website and an assessor will get in touch with you!

Important information
Venues

Where and when

Starts Location Timetable
Flexible
Distance learning

Frequent Asked Questions

· What are the objectives of this course?

The GIHS Program developed to prepare professionals for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to facilitate them with the educational foundation that will support them advance in the regulatory affairs profession. The program will provide the students with the fundamentals required in both regulatory affairs and quality operations. This course is designed to give industry level education in field of legal and regulatory issues. The program focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

· Who is it intended for?

This GIHS Program prepare you for work as a regulatory affairs professional in the medical device, in-vitro diagnostic, tissue, or pharmaceutical industries in specialized roles, such as regulatory affairs manager, pharmaceutical quality assurance manager, quality assurance director, and quality assurance supervisor.

· Requirements

All Science Graduates, MBBS, BDS, BHMS, BAMS, BPT, BUMS, Pharmacy, Occupational Therapist, Bsc, Msc, Life science, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech and all professionals working with Hospitals & Healthcare Organizations.

· What happens after requesting information?

On receiving your request, an academic officer from the the course will call you to explain everything about the course, including all enrollment procedure for the admission.

Opinions

K

10/05/2016
What I would highlight Thanks to the encouragement and support of my teacher I was able to get good results in my last exam. Thanks a lot!

What could be improved Nothing bad.

Would you recommend this course? Yes.

What you'll learn on the course

Pharmacy
Clinical Research
Regulatory Compliance
Clinical trials
Drug Laws
Drug Trial
Drug Development
Regulation Law
Regulation
Medical Research
Environmental Protection Act

Teachers and trainers (1)

Vijay Sharma
Vijay Sharma
CEO

Course programme


Dear Candidate,

Greetings,

SYLLABUS will be the same for all levels difference will be in details ands illustrations RA, IPR & Patents:

Section - 1

Regulatory Affairs

Pre-Clinical Trial

Clinical Trial

Regulatory Bodies in India

Central Drug Regulatory System

Drug & Cosmetics Act

Medical Device Registration in India

Product Development Protocol

Environmental Protection Act –1986

Section – 2

PHARMACEUTICAL LEGISTATION IN INDIA

11-The Narcotic drug & psychotropic substance act

12-Medicinal & Toilet preparation

13- Drug price control order in force

14-Laws on trademarks and copy rights

15- Prevention of cruelty to animal act

16-Consumer protection Act 1986

PHARMACEUTICAL REGULATION PRECESS IN INDIA

17-Regulatory consideration for pre clinical and clinical testing

18-Regulation and registration of medical devices

19- Regulation and registration of cosmetics

20-General drug approach

21-New drug development procedure in India & In different market

22-Guideline on the WHO certification In India & import export policy

REGULAITON OF GENERIC PHARMACEUTICAL AND BIO SIMILAR PRODUCT

23-Introduction and regulation of biosimilar in Indian & Europe

24-Introduction and worldwide regulation of herbal product

25- Introduction and regulatin of Orphan drug

26- SUBMISSION OF DRUG MASTER FILE TO USFDSA

27- Legal environment of business

28- Common Technical Documents

Section –3

Introduction to USFDA

ICH Guidelines

Drug Regulatory Authorities in European union with special reference to EMA & UKMHRA

WHO Guidelines

Auditing of Manufacturing Facility

Development of Orphan Drug

Additional information

Regulatory affairs (RA), also called government affairs, are a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs also have a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Global regulatory agencies are as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA).

Compare this course with other similar courses
See all