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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

10-11 Oct 2022

Book or reserve 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 and 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.


Module 1 – History and Review of the organisation of the US Food and Drug Administration (FDA) and future vision

  • The History of the FDA and Regulations
  • The FDA today
  • FDA’s reorganisation by Division
  • The Future Direction of FDA – FDA perspective

Module 2 – The drug development regulations in the US and implications for the industry

  • The Drug Development Process in the US
  • Clinical Trials and INDs – Discover the parties involved in development and the Types of INDs
  • Basic Understanding of the IND Content:
    • Analysing the manufacture of Drug Substance and Drug Product
    • Preclinical testing requirements
    • Clinical testing requirements

Module 3 - Analysing the Investigational New Drug Application (IND) and defining the regulatory requirements

  • Requirements for submitting an IND
  • Understand the FDA review process for INDs
  • Maintaining active INDs successfully
  • Clarifying the obligations of the Sponsor
  • Explaining the procedures for reporting Adverse Events (AEs)
  • Defining other IND amendments
  • Preparing Annual Reports

Module 4 - Evaluation of review options

Understanding the options:

  • Fast track
  • Breakthrough status
  • Accelerated review
  • Priority review
  • OTAT and RMAT Process / Interact

Module 5 - Identifying the various categories of NDAs

  • Defining full NDAs
  • Explaining abbreviated NDAs and 505 (b) (2)
  • How to mage Biological and Biosimilars
  • The Content Overview

Module 6 - Generic Submissions

  • Examine the legislative history and key regulations for ANDAs
  • Patent and exclusivity – Understand Paragraph 1-IV, and Biosimilars
  • Generic Drug User Fee Amendments (GDUFAs)
  • Opportunities for improvement and challenges
  • Managing launch activities including PLAIR

Module 7 - How does the FDA review and maintain an NDA?

  • Clarifying the procedure from the receipt to the filing of the NDA
  • Assessing when there will be a refusal to file
  • Sponsor - reviewer interactions
  • Maintaining NDAs successfully
  • When and how to do NDA amendments
  • Scale-up and post approval changes
  • Annual reports

Module 8 – Interacting with the FDA and Obtaining information from the FDA

  • FDA Meetings Type A, B and C
  • Meetings on Biosimilars
  • OTAT Meetings
  • The Summary Basis of Approval 
  • Advisory Meetings
  • Best Practice for Meetings


Marloes van der Geer (More...)

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

Hans van Bruggen (More...)

Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at global or European headquarters sites. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. He approaches interdisciplinary and international processes using that scientific background. He applies new technologies and Artificial Intelligence to facilitate the business and let people focus on what they can do best.

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Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at Reserve now
10-11 Oct 2022
Live webinar
UK (London)
10-11 Oct 2022
Live webinar
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 5 Sep*
Enrol now

to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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  • AstraZeneca
  • Auden McKenzie Group
  • BIAL - Portela & C.ª, S.A.
  • Cheplapharm Arzneimittel GmbH
  • DSTL
  • Eli Lilly Regional Operations GmbH
  • Ethypharm
  • Galderma R&D
  • Gilead Sciences
  • Grifols, S.A.
  • GW Pharmaceuticals
  • Hansa Medical AB
  • ImmuPharma
  • Leo Pharma A/S
  • NDA Regulatory Science Ltd.
  • Neem Biotech Ltd
  • Pharma Mar, S.A.
  • Pharmarov Consulting
  • Pharmathen S.A
  • Quotient Sciences Limited
  • Research and Markets
  • Sever Pharma Solutions
  • Sintetica SA
  • Swedish Orphan Biovitrum AB
  • Swedish Orphan Biovitrum AB (publ)
  • Torbay Pharmaceuticals
  • UCB
  • Valeant Pharma Poland Sp. z o.o.

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, Sep 21

Very informative and good.

Jayesh Tangutoori Mohan, Senior RA Manager, Atnahs Pharma UK Limited, Sep 21

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, Sep 19

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

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, Mar 19

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, Mar 19

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 18

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 18

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, Sep 18

Very clear content, excellent useful course and very knowledgable speaker

Claudia Williams, Senior Project Manager, Neem Biotech Ltd, Mar 18

Very good presentations

Natalie De Jonge, Regulatory Affairs Manager, argenx BVBA, Mar 18

Good value for money

Barbara Keller, Director Regulatory Strategy Personal Care, Bayer Consumer Care AG, Mar 18

Excellent and what I had hoped for

Andrew Germain, Associate Director, CMC Regulatory Affairs, GW Pharmaceuticals, Mar 18

Brilliant course, great speaker with excellent engagement

Jibran Ahmad, Senior Associate II, Biogen Idec Inc., Sep 17

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 17