Regulatory Compliance

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products. The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies.

  • Quality by Design (QbD)
  • Scope and importance of regulatory affairs
  • Marketing Authorizations
  • Current status of drug safety and pharmacovigilance
  • Intellectual Property rights
  • Drug Policy and Regulation
  • Regulatory issues in the pharmaceutical industry

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Regulatory Compliance Conference Speakers

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