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Post Graduate Diploma in Regulatory Affairs IPR and Patent

4.5
1 opinion
  • I’ve learnt a lot about "Regulatory affairs". Thank you for your great support and motivation to pass the exam.
    |

Postgraduate

Blended

£ 325 VAT inc.

*Indicative price

Original amount in INR:

₹ 32,000

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  • Type

    Postgraduate

  • Methodology

    Blended

  • Duration

    Flexible

  • Start date

    Different dates available

  • Online campus

    Yes

  • Delivery of study materials

    Yes

  • Support service

    Yes

  • Personal tutor

    Yes

Copyright From MHRD Government of India

Emagister.co.uk has just added this course on regulatory affairs (frequently called government affairs) to its catalogue. It is a profession than entails regulated industries regarding healthcare service, banking, energy, etc.

Global regulatory agencies are as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA).

It is a distance learning program, so you can study from the comfort of your home!

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

Facilities

Location

Start date

Blended

Start date

Different dates availableNow taking bookings

About 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.

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.

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.

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.

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Opinions

4.5
  • I’ve learnt a lot about "Regulatory affairs". Thank you for your great support and motivation to pass the exam.
    |
100%
4.5
fantastic

Course rating

Recommended

Centre rating

K.M.Subrahmanyam.

4.5
18/06/2017
What I would highlight: I’ve learnt a lot about "Regulatory affairs". Thank you for your great support and motivation to pass the exam.
What could be improved: .
Would you recommend this course?: Yes
Reviews gathered by Emagister & iAgora

This centre's achievements

This centre has demonstrated its quality on Emagister
4 years with Emagister

Subjects

  • Pharmacology
  • Medical
  • Clinical Research
  • Drug Development
  • Drug Trial
  • Medical Research
  • Medical training
  • Regulatory Compliance
  • Regulation Law
  • Regulation
  • Good Manufacturing Practice
  • Pharmacy
  • CLINICAL TRIALS
  • Pharmaceutical
  • Medical training
  • Environmental Protection Act
  • Regulatory Affairs
  • USFDA
  • MHRA
  • Drug Laws
  • TGA
  • Patent IPR
  • Patent Rights
  • Patent Rights

Teachers and trainers (1)

Professional   Coordinator

Professional Coordinator

Healthcare Specialist

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, IPR & PATENT  

Post Graduate Diploma Program (One Year) – 32000/- INR &  Fees for International Candidates  – 699 $ USD


Fast Track PG Diploma Program (4 Months) – 36000/- INR &  Fees for International Candidates  – 750 $ USD  

Online Registration & Admission Process:

Candidate have to fill the online registration form and have to upload passport photograph and signature. After the submission of online registration form candidate will receive mail regarding Acknowledgement Letter & Fee Payment Instructions.  Candidate have to pay the program fee within 7 working days on given bank information.

After fee payment candidate have to send scan copy of Bank Deposit Slip and Final year Mark-sheet or Degree Certificate or Provisional Certificate with your Admission Details (Application ID & Name) at Email: info@gihsonline.com.


MODE OF EXAMS Our IT department will provide you ID & Password for online examinations after completion of program.  You will have 7 days to appear online exams.  Your examination pattern would be Multiple Choice question MCQ and also need to submit power point project of minimum 30 pages of your own selected topic. After qualifying the exams, GIHS will deliver the two certification one would be DEGREE & second would be TRANSCRIPTIONAL Degree.

Call the centre

Post Graduate Diploma in Regulatory Affairs IPR and Patent

£ 325 VAT inc.

*Indicative price

Original amount in INR:

₹ 32,000