Site icon pharmaceutical daily

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:

Agenda:

Day One

Introduction, welcome and objectives

Overview of FDA organisation

Drug development regulatory requirements for FDA

Analysing the IND

Understanding regulatory strategic tools

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

Day Two

Recap of day one

Understanding PDUFA VI and GDUFA I

The NDA/ANDA process

Refusal to file issues

FDA review

FDA change control

FDA meetings/information

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

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

Exit mobile version