REGULATORY AFFAIRS, IPR & PATENT

Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is an ISO 21001:2018 Certified health science Institute & globally acclaimed, also certified with copyright approval from IPR Government of INDIA. GIHS have international certification from UASL UK for Quality Control Management System.

WHY CHOOSE US

• BRINGING EXCELLENCE TO HEALTH PROFESSIONALS
• 10+ YEARS OF EXPERIENCE WITH INTERNATIONAL EXPOSURE
• INTERNATIONAL ACLAIMED WITH ISO & GOVT APPROVED
• LIFETIME FREE PERSONALIZED TUTORING FOR SUCCESS

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 globally and professionals can be recruited in Pharma companies, medical devices, biotech, biologics and functional food areas.

It deals with government or law. Global regulatory agencies are as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA).

This Program is 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.

SYLLABUS

Regulatory Affairs

• Pre-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 India

• The 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 India

• Regulatory 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 Product

• Introduction 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 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
• Guideline for rest of World
• IPR, Patents, Quality Assurance, Projects

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