- Post Graduate Diploma
- Distance learning
- Delivery of study materials
- Support service
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.
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.
What could be improved Nothing bad.
Would you recommend this course? Yes.
What you'll learn on the course
Environmental Protection Act
Teachers and trainers (1)
SYLLABUS will be the same for all levels difference will be in details ands illustrations RA, IPR & Patents:
Section - 1
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
Introduction to USFDA
Drug Regulatory Authorities in European union with special reference to EMA & UKMHRA
Auditing of Manufacturing Facility
Development of Orphan Drug