Syllabus – Regulatory affairs IPR & Patent

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

Gihsonline Advantage

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.

  • BRINGING EXCELLENCE TO HEALTH PROFESSIONALS

    BRINGING EXCELLENCE TO HEALTH PROFESSIONALS

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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

Cheque / Demand Draft/Cash in the name of “Global Institute of Health Science”

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

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.

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

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. 

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. 

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. 

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