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The FDA (Food and Drug Administration) Drug Approval Process Training Course

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

★★★★★ "[I particularly liked] How complete it was but concise and with key topics and important information... more (23)"

23-24 February 2026
+ 24-25 September 2026 »
from £1299

Need help? Enrol/reserve

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 and Improve your communication and interactions with the FDA

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

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.

Enrol/reserve

Andrew Willis
San Salvatore Training Ltd

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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

23-24 February 2026

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15842

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 19 Jan

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

24-25 September 2026

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 16397

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 20 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's The FDA Drug Approval Process training course

[I particularly liked] How complete it was but concise and with key topics and important information. Clear communications from speaker. Always available to respond every questions and really knowledgeable about the topic. 5*.

Oct 7 2025

Carolina Coelho Germany
Manager, Regulatory Affairs, InflaRx GmbH

Jun 12 2024

I was hoping to gain a better understanding of the US approval process as I currently work on EU registrations but am moving to a more global role. The webinar covered the US process really well and I don't feel there was anything missed.

Susan Scanlan United Kingdom
Principal Scientist, Dechra Limited

Dec 2 2024

[Speaker] answered all the questions, and the discussions were super helpful. Very satisfied. Would recommend.

Camila Tavares Denmark
International Medical Manager, Novo Nordisk

Oct 2 2023

A good, detailed process of FDA drug approval process

Richa Dcruz Ireland
Regulatory Affairs officer, Shorla Oncology

Jun 14 2023

Very good webinar I am glad I was able to attend.

Magdalena Olszewska Poland
Sr. Director RA EMEA, Bausch Health Poland Sp. z o.o.

Oct 10 2022

Good webinar focused on various stages of the FDA drug/device approval process.

Jillian Green United Kingdom
Assistant Regulatory Operations Manager, Kalvista Pharmaceuticals

Sep 20 2021

Very informative and good.

Jayesh Tangutoori Mohan United Kingdom
Senior RA Manager, Atnahs Pharma UK Limited

Sep 20 2021

It was a well structured, well presented webinar with engaging speakers. I came away feeling like I have a much better understanding about the US regulatory system. The content covered a wide range of areas, and although not all was relevant to me, it was interesting and valuable.

Jenny Lakin United Kingdom
Head of Product Registration, Torbay Pharmaceuticals

Mar 21 2019

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 United Kingdom
Regulatory Director, Futura Medical

Sep 19 2019

Andrew was knowledgeable, experienced and a good relaxed speaker. I liked the ability to ask a lot of questions due to the size of the group.

Karin Jackson Sweden
Regulatory Coordinator, Hansa Medical AB

Sep 19 2019

Enjoyable course from a very enthusiastic presenter with good content on comparisons between EU and US structures. I would recommend this course to colleagues.

Ciara Walsh Ireland
Head of Regulatory Affairs and Pharmacovigilance, Noden Pharma DAC

Mar 21 2019

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 United Kingdom
Director, Allergan Ltd

Sep 13 2018

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

Adeline Boucher Belgium
Director of Regulatory Affairs, Ablynx NV

Mar 22 2018

Excellent and what I had hoped for

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

Mar 22 2018

Good value for money

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

Mar 22 2018

Very good presentations

Natalie De Jonge Belgium
Regulatory Affairs Manager, argenx BVBA

Mar 22 2018

Very clear content, excellent useful course and very knowledgable speaker

Claudia Williams United Kingdom
Senior Project Manager, Neem Biotech Ltd

Sep 13 2018

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

Aikaterini Sakka Greece
Commercial Legal Lead, Pharmathen S.A

Sep 13 2018

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

Brian Lavery United Kingdom
Regulatory Affairs Lead, Almac Group

Sep 20 2017

All good

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

Sep 20 2017

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

Sep 20 2017

Brilliant course, great speaker with excellent engagement

Jibran Ahmad United Kingdom
Senior Associate II, Biogen Idec Inc.

Sep 20 2017

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 Spain
Immunoglobulins Manager, Grifols S.A

United Kingdom