Global Institute of Health Science

      Post Graduate Diploma in Regulatory Affairs IPR and Patent

      4.5 1 opinion
      Global Institute of Health Science
      Distance
      • Global Institute of Health Science

      £323
      *Guide price
      Original amount in INR:
      Rs28,000
      PREMIUM COURSE
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      Important information

      Typology NVQ
      Methodology Distance Learning
      Duration Flexible
      Start Different dates available
      • NVQ
      • Distance Learning
      • Duration:
        Flexible
      • Start:
        Different dates available
      Description

      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 (1)
      Where and when
      Starts Location
      Different dates available
      Distance Learning
      Starts Different dates available
      Location
      Distance Learning

      To take into account

      · 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.

      Questions & Answers

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      Opinions

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      Reviews on this course

      K
      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
      Did this opinion help you? Yes (0)
      Reviews gathered by Emagister & iAgora

      What you'll learn on the course

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

      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).