Presented by
Management Forum

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

21-22 Mar 2022 + 2 more dates

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  • Format: Live online, Classroom
  • 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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Book The FDA Drug Approval Process Live online/Classroom training

21-22 Mar 2022

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 11574

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

Until 14 Feb

In your basket 

20-21 Jun 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11370

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 16 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

19-20 Sep 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11690

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

Until 15 Aug

In your basket 

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

UK

  • Allergan Ltd
  • Alliance Pharma plc and Alliance Pharmaceuticals Ltd
  • Almac Group
  • Ascension Healthcare
  • Atnahs Pharma UK Limited
  • Auden McKenzie Group
  • Biogen Idec Inc.
  • DSTL
  • Eisai Ltd
  • Ethypharm
  • Freeline Therapeutics
  • Futura Medical
  • Gilead Sciences
  • GW Pharmaceuticals
  • MedImmune Limited
  • Molnlycke Healthcare
  • NDA Regulatory Science Ltd
  • NDA Regulatory Science Ltd.
  • Neem Biotech Ltd
  • Pharmarov Consulting
  • Quotient Sciences Limited
  • Torbay Pharmaceuticals

Germany

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

Belgium

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

Sweden

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

Netherlands

  • Disphar International B.V.
  • Galapagos
  • Merus NV
  • Sever Pharma Solutions

France

  • Galderma R&D
  • ImmuPharma
  • LFB Biomedicaments

Spain

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

Switzerland

  • Bayer Consumer Care AG
  • DNDi
  • ObsEva SA

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

Poland

  • Valeant Pharma Poland Sp. z o.o.

Portugal

  • BIAL - Portela & C.ª, S.A.

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Multiple colleagues?
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