Syllabus – Regulatory affairs IPR & Patent

Regulatory affairs IPR & Patent

Regulatory AffairsPre-Clinical Trial
Clinical Trial
Regulatory Bodies in India
Central Drug Regulatory System
Drug & Cosmetics Act
Schedule – Y
Medical Device Registration in India
Product Development Protocol
Environmental Protection Act –1986
Pharmaceutical Legislation in IndiaThe Narcotic drug & psychotropic substance act
Medicinal & Toilet preparation
Drug price control order in force
Laws on trademarks and copy rights
Prevention of cruelty to animal act
Consumer protection Act 1986
Pharmaceutical Regulation Process in IndiaRegulatory consideration for pre-clinical and clinical testing
Regulation and registration of medical devices
Regulation and registration of cosmetics
General drug approach
New drug development procedure in India & In different market
Guideline on the WHO certification in India & import export policy

Regulation of Generic Pharmaceutical and Bio Similar ProductIntroduction and regulation of biosimilar in Indian & Europe
Introduction and worldwide regulation of herbal product
Introduction and regulation of Orphan drug
Submission of Drug Master File to USFDA
Legal environment of business
Common Technical Documents
Introduction to USFDAICH Guidelines
Drug Regulatory Authorities in European union with special reference to EMA & UKMHRA
WHO Guidelines
Auditing of Manufacturing Facility
Development of Orphan Drug
Guideline for rest of World
IPR, Patents, Quality Assurance, Projects

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GIHS provides the best courses helps you to get the start up in the healthcare field. These courses are ad-hoc to your professional career and provide you the additional benefit to be the part of an organization.

Fees, Payment & Program Duration

Certificate 3 Months- 22000/- INR & Fees for International Candidates – 450$ USD

PG DIploma One Year – 32000/- INR & Fees for International Candidates – 699$ USD

FT PG Diploma 4 Months – 36000/- INR & Fees for International Candidates – 750$ USD

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Online Transfer through NEFT or RTGS

Fee can also be deposited in GIHS bank account (For more details Click Here).

Disclaimer: This course details are for the purpose of awareness about the program and career opportunities.

The exact information on course structure may vary from this information.

Frequently Asked Questions

Does regulatory affairs pay well?

While the specifics may depend on different factors, generally regulatory affairs professionals are well-compensated. This is because of the critical role they play in ensuring compliance with regulations and facilitating the approval of products.

What is the role of regulatory affairs?

The role of regulatory affairs involves ensuring that products comply with regulatory requirements, especially in industries like pharmaceuticals, biotechnology, and medical devices.

Is there a scope for regulatory affairs?

Yes, there is significant scope for regulatory affairs professionals, especially in industries like pharmaceuticals and healthcare. As regulatory requirements continue to evolve, companies are looking for professionals who can help them abide by complex regulations.

What is the scope of IPR in the pharma industry?

IPR or intellectual property rights in the pharma industry are crucial for protecting innovations, inventions, and proprietary knowledge related to drugs and healthcare products. Professionals in the field play a key role in securing patents, trademarks, and copyrights.

Is IPR a good career in India?

Yes, IPR is a promising career in India, especially in industries like pharmaceuticals where innovation and protection of intellectual property are critical. With the increasing emphasis on research and development, the demand for professionals with expertise in IPR, including patent agents and attorneys, is growing in India.

Syllabus – Regulatory affairs IPR & Patent

Syllabus – Regulatory affairs IPR & Patent

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Frequently Asked Questions

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