The FDA Drug Approval Process – Two Day Event: London, United Kingdom – September 21-22, 2020 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “The FDA Drug Approval Process” conference has been added to ResearchAndMarkets.com’s offering.

This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.

The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region.

The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight 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.

There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.

Benefits of attending:

• Review the latest FDA regulatory requirements for drug development
• Understand FDA regulatory strategic needs
• Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
• Discuss recent changes and developments with an industry expert n Improve your communication and interactions with the FDA

Agenda:

Day One

Introduction, welcome and objectives

Overview of FDA organisation

• History of the FDA
• The FDA today
• FDA future
• Organisation of FDA and divisions.

Drug development regulatory requirements for FDA

• Different types of INDs
• Overview of US drug development

Analysing the IND

• Organisation of the IND
• IND submission procedures
• FDA review of IND
• FDA actions on INDs
• Maintaining the IND

Understanding regulatory strategic tools

• Access tools
• Fast track, breakthrough, accelerated, priority
• Expanded access options

Case study: Exercise to identify key scientific meeting points during development

Day Two

Recap of day one

Understanding PDUFA VI and GDUFA I

• What are PDUFA and GDUFA?
• NDA/biologics and biosimilars (BLA)
• 505(b)(2) applications
• Generics

The NDA/ANDA process

Refusal to file issues

FDA review

• CTD review
• Quality systems (questions from FDA)
  
  – IID
  
  – QbR
  
  – Stability

FDA change control

• Maintaining the NDA and ANDA
• Your obligations
• PAS/CBE and annual reports

FDA meetings/information

• Types of meetings
• Best practice at meetings
• FDA website
• Controlled communication

Freedom of Information Act (FOIA) and practical application

For more information about this conference visit https://www.researchandmarkets.com/r/nvabq2

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

[email protected]

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