Biopharmaceutical Regulatory Affairs and Intellectual Property Rights

Regulatory Science is the science of advanced standards equipment, and paths to assess the safety, Drug toxicity and quality, potency of all FDA-regulated products. An access to lengthen the programs in regulatory science that leverages what has been well-educated in the development of training programs for translational scientists, and this model for regulatory science program development is being refined and adopted by all of the institutions that are part of the CTSA network. The target audience for such a program is broad, noted that it is necessary to break out of the mind-set that regulatory science resides totally with FDA and that the field's purpose is to create a workforce that will function within the FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program understand research and scientific methodology, toxicology, therapeutics, and pharmacology that underpin the regulatory process. The importance of intellectual property law is well established at all levels-statutory, administrative and judicial. It lays down minimum standards for protection and enforcement in member countries which are required to promote effective and adequate protection of intellectual property rights with a view to reducing distortions and impediments to international trade.

The Agreement provides norms and standards in respect of following areas of intellectual properties are Patents, Trademarks, copyrights, Geographical indications, Industrial designs

  • Drug Regulations and Organizations
  • Intellectual Property Law for Generics and Innovator Rights
  • Regulatory Approvals for Biopharma drug products
  • Biopharma Regulatory challenges
  • Safety and Quality Regulation in Labelling
  • Global Pharma Products Registration

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