A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
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. 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 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
Programme day one
Introduction, welcome and objectives
Overview of FDA organisation
- History of the FDA
- The FDA today
- FDA future
- Organisation of FDA and divisions including:
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
Programme 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
- Patents and exclusivity
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
Mr Andrew Willis,
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment. He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.