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
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