Regulatory Communications and Submissions

Due to the growing interest in marketing new products, it is pivotal to establish a superior level of medical writing and regulatory operations. Executives within these roles need to create and manage successful submissions, as well as streamline timelines, to accelerate approval.

Attending the Optimizing Regulatory Communications and Submissions conference will aid delegates in expediting the approval of drugs while meeting requirements for different regulatory agencies worldwide. In addition, attendees will overcome key operational challenges impacting the approval process to enhance the quality of submissions.

  • Global guidelines for the development of biologics
  • Review of biologic products
  • Biologics development
  • FDA CDER and CBER review
  • Speed Biologics development
  • Global trend for Biologics
  • Regulating regenerative medicine
  • Cosmetics
  • CTD, eCTD

Related Conference of Regulatory Communications and Submissions

November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan

Regulatory Communications and Submissions Conference Speakers

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