Copyright From MHRD Government of India

Post Graduate Diploma in Regulatory Affairs IPR and Patent

4.5 excelente 1 opinión
Global Institute of Health Science
Distancia

$ 1.269.191
*Precio Orientativo
Importe original en INR:
Rs 28.000

Información importante

Tipología NVQ
Metodología A distancia
Duración Flexible
Inicio Fechas a escoger
  • NVQ
  • A distancia
  • Duración:
    Flexible
  • Inicio:
    Fechas a escoger
Descripción

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!

Información importante
¿Qué objetivos tiene esta formación?

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.

¿Esta formación es para mí?

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.

¿Qué pasará tras pedir información?

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.

Requisitos: 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.

Sedes

Dónde se imparte y en qué fechas

Inicio Ubicación
Fechas a escoger
Distance Learning
Inicio Fechas a escoger
Ubicación
Distance Learning

Opiniones

4.5
excelente
Valoración del curso
100%
Lo recomiendan
4.8
excelente
Valoración del Centro

Opiniones sobre este centro

K
K.M.Subrahmanyam.
18/06/2017
Lo mejor: I’ve learnt a lot about "Regulatory affairs". Thank you for your great support and motivation to pass the exam.
A mejorar: .
Curso realizado: Junio 2017
¿Recomendarías este centro?:

¿Qué aprendes en este curso?

Pharmacology
Medical
Clinical Research
Drug Development
Drug Trial
Medical Research
Medical training
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

Programa académico


  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

Información adicional

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).