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
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
Recap of day one
Understanding PDUFA VI and GDUFA I
- What are PDUFA and GDUFA?
- NDA/biologics and biosimilars (BLA)
- 505(b)(2) applications
The NDA/ANDA process
Refusal to file issues
- CTD review
Quality systems (questions from FDA)
FDA change control
- Maintaining the NDA and ANDA
- Your obligations
- PAS/CBE and annual reports
- 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