2-Day Course: The FDA Drug Approval Process (London, United Kingdom - March 21-22, 2019) - ResearchAndMarkets.com

DUBLIN--()--The "The FDA Drug Approval Process" conference has been added to ResearchAndMarkets.com's offering.

This course is designed to help you gain a better understanding of the US drug approval process. You will gain a practical insight into FDA requirements for submission of NDAs, ANDAs and 505(b)(2). It will also cover the organisation and structure of the FDA and review processes, as well as discuss recent changes.

The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.

Benefits of attending:

  • Gain an overview of FDA drug development regulatory requirements
  • Comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
  • Discuss recent changes and developments
  • Improve your communication and interactions with the FDA

Agenda

Programme Day One

An overview of the US FDA Drug development regulatory requirements for FDA

  • Overview of INDs
  • Data requirements for drug substance and drug product
  • Pre-clinical testing and clinical testing
  • The different phases of development

Drug development regulatory requirements for FDA (continued)

Overview of the IND application and the data requirements

  • IND structure
  • Submission procedure
  • IND review
  • FDA actions

Maintenance of INDs

  • Structure and content of STED
  • Technical File vs Design Dossier

Identifying recent changes

  • Examining accelerated review and breakthrough status
  • Paediatric legislation
  • Financial disclosure
  • Clinical trial transparency
  • Exclusivity and patent declaration

Workshop: Understanding FDA meetings

  • An overview of the different types of FDA meetings
  • Create a best practice guide for meeting preparation and attendance

Programme Day Two

Identifying the NDA types and categories

  • What is a full NDA?
  • 505(b)(2) applications
  • CTD requirements
  • FDA approach to CTD format
  • Review approach
  • US regional requirements

Review of ANDA/NDA

Understanding ANDA classification

  • Examining paragraph I-IV
  • Overview of GDUFA

US change control - amendments

  • NDA/ANDA amendments
  • SUPAC/BACPAC guidance
  • Annual reports/CBE and PAS applications
  • NDA annual report requirements

Obtaining information from the FDA

  • Access to Federal Register
  • FOIA
  • FDA homepage

Final discussion and review of day

For more information about this conference visit https://www.researchandmarkets.com/research/qxdkmb/2day_course_the?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Drug Discovery

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Drug Discovery