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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 was hoping to gain a better understanding of the US approval process as I currently work on EU reg... more (21)"

2-3 December 2024
+ 24-25 February 2025, 11-12 June 2025, 7-8 October 2025 »

from £1099

Need help?  Enrol or 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

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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 or reserve

This course will cover:

Pharmaceutical Medicine and Documents

  • The role of regulatory affairs
  • The purpose of the Common Technical Document (CTD)

FDA History and Organisation

  • Review of FDA centers
  • Organization of the CDER and CBER
  • Differences between CDER and CBER

Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)

  • 21st century cure act
  • Patent and exclusivity
  • BsUFA

Legal Basis Continued

Application and Submissions Types

  • Investigational new drugs (IND)
  • New drug applications (NDA)
  • Abbreviated new drug applications (ANDA)
  • Over the counter drugs (OTC)
  • Biologics license applications (BLA)
  • Orphan drug designations

Refusal to File

  • Reasons for refusal
  • The regulatory process

Investigational New Drug (IND) Applications

  • Review of the content of an IND

Getting Products to the Market Faster

  • Review of expedited programs in the US
    • Fast Track designation
    • Breakthrough Therapy designation
    • Accelerated Approval
    • Priority Review designation

FDA Meetings and Documentation

  • FDA communication philosophy
  • Different meeting types
    • Scope
    • Format
    • Procedure

CTD Content - Setting the Scene

  • Lean authoring to ensure possible document re-use for multiple purposes
  • A review of the different modules

CTD Content - M1

CTD Content - M3 and Corresponding M2

CTD Content - M4 and Corresponding M2

CTD Content - M5 and Corresponding M2

Submission Format and Methods

  • Study tagging files
  • Datasets
    • Case report forms
    • Bioresearch monitoring (BIMO) clinical data

US Amendment Procedures

  • A review of US amendment procedures (incl. annual reports, minor/major changes)

High Level Comparison US vs EU

  • A review of the main differences in terms of dossier content and procedures

Case Study

Enrol or 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

2-3 December 2024

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 13917

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 28 Oct

View basket 

Not ready to book yet?

for 7 days, no obligation

24-25 February 2025

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 14489

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 20 Jan

View basket 

Not ready to book yet?

for 7 days, no obligation

11-12 June 2025

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 14744

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 07 May

View basket 

Not ready to book yet?

for 7 days, no obligation

7-8 October 2025

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 15109

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 02 Sep

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 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.

Jun 12 2024

Susan Scanlan
Regulatory Affairs Scientific Leader - CMC, Dechra Limited

Oct 2 2023

A good, detailed process of FDA drug approval process

Richa Dcruz
officer, Shorla Oncology

Jun 14 2023

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

Magdalena Olszewska
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
Assistant Regulatory Operations Manager, Kalvista Pharmaceuticals

Sep 20 2021

Very informative and good.

Jayesh Tangutoori Mohan
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
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
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
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
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
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
Director of Regulatory Affairs, Ablynx NV

Mar 22 2018

Excellent and what I had hoped for

Andrew Germain
Associate Director, CMC Regulatory Affairs, GW Pharmaceuticals

Mar 22 2018

Good value for money

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

Mar 22 2018

Very good presentations

Natalie De Jonge
Regulatory Affairs Manager, argenx BVBA

Mar 22 2018

Very clear content, excellent useful course and very knowledgable speaker

Claudia Williams
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
Legal Expert, 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
Regulatory Affairs Lead, Almac Group

Sep 20 2017

All good

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

Sep 20 2017

Brilliant course, great speaker with excellent engagement

Jibran Ahmad
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
Immunoglobulins Manager, Grifols S.A

United Kingdom

  • Allergan Ltd
  • Alliance Pharma plc and Alliance Pharmaceuticals Ltd
  • Almac Group
  • Arecor Limited
  • Ascension Healthcare
  • Atnahs Pharma UK Limited
  • Auden McKenzie Group
  • Biogen Idec Inc.
  • Carpmaels & Ransford LLP
  • Cycle Pharmaceuticals Ltd
  • Dechra Limited
  • DSTL
  • Eisai Ltd
  • Ethypharm
  • Freeline Therapeutics
  • Futura Medical
  • Gilead Sciences
  • GW Pharmaceuticals
  • Kalvista Pharmaceuticals
  • MedImmune Limited
  • Molnlycke Healthcare
  • NDA Regulatory Science Ltd
  • NDA Regulatory Science Ltd.
  • Neem Biotech Ltd
  • Pharmarov Consulting
  • Quotient Sciences Limited
  • Tay Therapeutics
  • Terumo BCT
  • Torbay Pharmaceuticals


  • Bavarian Nordic
  • Boehringer Ingelheim Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • Cheplapharm Arzneimittel GmbH
  • Grünenthal GmbH
  • Helm AG
  • ITM Radiopharma
  • Life Molecular Imaging
  • Life Molecular Imaging GmbH
  • Merck KGaA


  • Ablynx NV
  • Ardena
  • argenx BVBA
  • Galapagos NV
  • SGS Belgium NV
  • Terumo BCT Europe N.V.
  • UCB


  • BlueReg
  • Chiesi SAS
  • DBV Technologies
  • Galderma R&D
  • Guerbet
  • ImmuPharma
  • LFB Biomedicaments


  • Almirall, SA
  • Grifols S.A
  • Grifols, S.A.
  • Noucor
  • Noucor Health, S.A.
  • Pharma Mar, S.A.


  • AstraZeneca
  • Camurus AB
  • Hansa Medical AB
  • Medivir AB
  • Swedish Orphan Biovitrum AB
  • Swedish Orphan Biovitrum AB (publ)


  • Bayer Spa
  • Skillpharma S.r.l.
  • Zambon SpA


  • Ares Trading S.A
  • Bayer Consumer Care AG
  • DNDi
  • ObsEva SA
  • Sintetica SA


  • Genepharm SA
  • Pharmathen
  • Pharmathen S.A


  • CR2O
  • Galapagos
  • Merus NV
  • Sever Pharma Solutions


  • Eli Lilly Regional Operations GmbH
  • EVER Valinject GmbH
  • Hookipa Biotech AG


  • Bausch Health Poland Sp. z o.o.
  • Bausch Health Poland Sp. z o.o.
  • Valeant Pharma Poland Sp. z o.o.


  • Xellia d.o.o.


  • LEO Pharma
  • Leo Pharma A/S


  • Noden Pharma DAC
  • Shorla Oncology


  • BIAL - Portela & C.ª, S.A.
  • Owlpharma Consulting. Lda.

United States of America

  • Chiesi USA, Inc.
  • The Jackson Laboratory


  • Orion Corporation Orion Pharma


  • Gedeon Richter


  • AS Kalceks

Enrol or reserve

Run The FDA Drug Approval Process Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749