The FDA Drug Approval Process (London, United Kingdom - March 21-22, 2019)

  • ID: 4745578
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: March 21-22, 2019
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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
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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

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This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.

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ADDRESS

Holiday Inn London Kensington Forum
97 Cromwell Road
London
SW7 4DN
United Kingdom

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Order Online - visit: https://www.researchandmarkets.com/reports/4745578
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