The FDA Drug Approval Process

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

12-13 Mar 2020

& 21-22 Sep 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

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

Who should attend?

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.

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

- Pre-clinical
- Clinical

Analysing the IND

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

- Obligations
- Amendments
- Annualreports

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
  • Generics

- Patents and exclusivity

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


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, where 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 had 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 has over 30 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.

Book now

12-13 Mar 2020
12-13 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
Limited places
21-22 Sep 2020
21-22 Sep 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • Allergan Ltd
  • Almac Group Ltd
  • Auden McKenzie Group
  • Biogen Idec Inc.
  • Cheplapharm Arzneimittel GmbH
  • DNDi
  • Eisai Ltd
  • Futura Medical
  • Galapagos NV
  • Galderma R&D
  • Grifols, S.A.
  • Grünenthal GmbH
  • GW Pharmaceuticals
  • Hansa Medical AB
  • Hookipa Biotech AG
  • ImmuPharma
  • LEO Pharma
  • Leo Pharma A/S
  • MedImmune Limited
  • Merck KGaA
  • Merus NV
  • Molnlycke Healthcare
  • NDA Regulatory Science Ltd
  • Noden Pharma DAC
  • Pharma Mar, S.A.
  • Pharmathen S.A
  • UCB
  • Valeant Pharma Poland Sp. z o.o.
  • Xellia d.o.o.
  • Zambon SpA

Comprehensive content, relaxed atmosphere. Very approachable presenter. Easy atmosphere to ask questions and expand on certain items to get good understanding. Quite heavy CMC focus. I would have liked to see a more balanced content to include more clinical and labelling focus also.

Claire Whitley, Director, Allergan Ltd

Hands down the best course I've ever taken. A great venue, where we were well fed and watered, a comprehensive and high quality set of course notes, and a truly outstanding speaker.

Rachael Hawken, Regulatory Director, Futura Medical

One of the best speakers I have met so far. Excellent course due to an excellent speaker.

Aikaterini Sakka, Legal Expert, Pharmathen S.A

Very good course. Excellent interactive speaker giving real world experience and making the course relevant to the participants.

Brian Lavery, Regulatory Affairs Lead, Almac Group

Well delivered, just the right level, and well tailored to the needs of the individuals of the group.

Adeline Boucher, Director of Regulatory Affairs, Ablynx NV

Excellent and what I had hoped for

Andrew Germain, Associate Director, CMC Regulatory Affairs, GW Pharmaceuticals

Very clear content, excellent useful course and very knowledgable speaker

Claudia Williams, Senior Project Manager, Neem Biotech Ltd

Good value for money

Barbara Keller, Director Regulatory Strategy Personal Care, Bayer Consumer Care AG

Very good presentations

Natalie De Jonge, Regulatory Affairs Manager, argenx BVBA

The best course I have attended so far. Excellent Speaker with great knowledge (both theoretical and practical) able to share it in a perfect way. Speaker, who is able to turn every participant on to what he is presenting.

Magdalena Olszewska, Regulatory Affairs Manager EMEA, Valeant Pharma Poland Sp. z o.o.

The course was interesting and the speaker was nice and friendly. The programme was too extensive for only two days and some topics as quality and supplements and other changes were dealt very quickly.

Elisenda Soms Alabart, Immunoglobulins Manager, Grifols S.A

All good

Irene Garcia Bravo, RA Associate Director, Pharma Mar, S.A.

Brilliant course, great speaker with excellent engagement

Jibran Ahmad, Senior Associate II, Biogen Idec Inc.