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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

★★★★★ "Hands down the best course I've ever taken. A great venue, where we were well fed and watered, a com... more"

27-28 Jun 2022 + 1 more date

Need help?  Enrol now

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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.

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The The FDA Drug Approval Process course will cover:

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

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Marloes van der Geer

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).

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Hans van Bruggen

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 The FDA Drug Approval Process Live online training

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*

27-28 Jun 2022

Live online

Course code 11370

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 25 May

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19-20 Sep 2022

Live online

Course code 11690

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 15 Aug

View basket 

* 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.

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


Very informative and good.

Sep 20 2021

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
  • Ascension Healthcare
  • Atnahs Pharma UK Limited
  • Auden McKenzie Group
  • Biogen Idec Inc.
  • Carpmaels & Ransford LLP
  • 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
  • Torbay Pharmaceuticals

Belgium

  • Ablynx NV
  • Ardena
  • argenx BVBA
  • GALAPAGODS NV
  • Galapagos NV
  • UCB

Germany

  • Bavarian Nordic
  • Boehringer Ingelheim Vetmedica GmbH
  • Cheplapharm Arzneimittel GmbH
  • Grünenthal GmbH
  • Life Molecular Imaging
  • Merck KGaA

Sweden

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

Switzerland

  • Bayer Consumer Care AG
  • DNDi
  • ObsEva SA
  • Sintetica SA

France

  • Galderma R&D
  • ImmuPharma
  • LFB Biomedicaments

Netherlands

  • Galapagos
  • Merus NV
  • Sever Pharma Solutions

Spain

  • Grifols S.A
  • Grifols, S.A.
  • Pharma Mar, S.A.

Austria

  • Eli Lilly Regional Operations GmbH
  • Hookipa Biotech AG

Denmark

  • LEO Pharma
  • Leo Pharma A/S

Greece

  • ELPEN PHARMACEUTICAL CO. INC.
  • Pharmathen S.A

Italy

  • SKILLPHARMA S.r.l.
  • Zambon SpA

Croatia

  • Xellia d.o.o.

Finland

  • Orion Corporation Orion Pharma

Ireland

  • Noden Pharma DAC

Latvia

  • AS Kalceks

Poland

  • Valeant Pharma Poland Sp. z o.o.

Portugal

  • BIAL - Portela & C.ª, S.A.

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Run The FDA Drug Approval Process Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • 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 expert Aleksandra Beer 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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy