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
  • Trends in designing chemistry, manufacturing and controls (CMC) components of regulatory submissions
  • Current Trends in Planning, Preparation and Delivering Regulatory Submissions
  • 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

June 06-07, 2018

International Conference & B2B on Pharma Research and Development

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12th Asian Biologics and Biosimilars Congress

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October 18-20, 2018

18th World Pharma Congress

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November 15-16, 2018

14th International Conference on Generic Drugs and Biosimilars

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6 th European Biopharma Congress

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Regulatory Communications and Submissions Conference Speakers

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