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

January 23, 2019

DUBLIN--(BUSINESS WIRE)--Jan 23, 2019--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


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

View source version on businesswire.com:https://www.businesswire.com/news/home/20190123005328/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager


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Related Topics:Drug Discovery



SOURCE: Research and Markets

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PUB: 01/23/2019 05:15 AM/DISC: 01/23/2019 05:15 AM


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