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The FDA 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

11-12 Mar 2021

& 18-19 Mar 2021 , 20-21 Sep 2021 , 27-28 Sep 2021

Book now

Details

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 n 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.

Programme

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

Presenter

Andrew Willis (More...)

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.

Book now

Book now

11-12 Mar 2021
Live webinar
11-12 Mar 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 28 Jan 21*
Enrol now
to attend
Live webinar
18-19 Mar 2021
Face-to-face, (venue not yet confirmed)
18-19 Mar 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 4 Feb 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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
20-21 Sep 2021
Live webinar
20-21 Sep 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 9 Aug 21*
Enrol now
to attend
Live webinar
27-28 Sep 2021
Face-to-face, (venue not yet confirmed)
27-28 Sep 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 16 Aug 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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

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

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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Previous customers include...

  • Almac Group Ltd
  • Ascension Healthcare
  • Auden McKenzie Group
  • Bavarian Nordic
  • Currently self employed
  • DSTL
  • Eisai Ltd
  • Eli Lilly Regional Operations GmbH
  • Freeline Therapeutics
  • Futura Medical
  • Galderma R&D
  • Grünenthal GmbH
  • GW Pharmaceuticals
  • LEO Pharma
  • Leo Pharma A/S
  • LFB Biomedicaments
  • MedImmune Limited
  • Merck KGaA
  • Merus NV
  • Molnlycke Healthcare
  • NDA Regulatory Science Ltd.
  • NDA Regulatory Science Ltd. - Leatherhead
  • Neem Biotech Ltd
  • Noden Pharma DAC
  • ObsEva SA
  • Orion Corporation Orion Pharma
  • Pharmathen S.A
  • Swedish Orphan Biovitrum AB
  • Swedish Orphan Biovitrum AB (publ)
  • Xellia d.o.o.

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

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, Sep 17

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

All good

Irene Garcia Bravo, RA Associate Director, Pharma Mar, S.A., Sep 17