Regulatory Affairs

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, pesticides, agrochemicals, 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 authorized medicinal products. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical industry. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

  • Importance and scope in pharma industry
  • Regulatory procedure manual
  • Regulatory Compliance
  • Good Regulatory Practices
  • Conflicts and Solution Trends in Regulatory issues
  • Drug Design and development for compliancing with Regulatory Policies
  • Code of Federal Regulations

Related Conference of Regulatory Affairs

June 06-07, 2018

International Conference & B2B on Pharma Research and Development

Philadelphia, Pennsylvania, USA
August 20-21, 2018

12th Asian Biologics and Biosimilars Congress

Tokyo, Japan
October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
November 15-16, 2018

14th International Conference on Generic Drugs and Biosimilars

Frankfurt, Germany
September 18-19, 2018

6 th European Biopharma Congress

Amsterdam, Netherlands

Regulatory Affairs Conference Speakers

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