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

19-20 Sep 2019

& 12-13 Mar 2020 , 21-22 Sep 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 9 Aug

Book now

Course overview

This course is designed to help you gain a better understanding of the US drug approval process. You will gain a practical insight into FDA requirements for submission of NDAs, ANDAs and 505(b)(2). It will also cover the organisation and structure of the FDA and review processes, as well as discuss 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.

Benefits of attending:

  • Gain an overview of FDA drug development regulatory requirements
  • Comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
  • Discuss recent changes and developments
  • 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 day one

An overview of the US FDA Drug development regulatory requirements for FDA

  • Overview of INDs
  • Data requirements for drug substance and drug product
  • Pre-clinical testing and clinical testing
  • The different phases of development

Drug development regulatory requirements for FDA (continued)

Overview of the IND application and the data requirements

  • IND structure
  • Submission procedure
  • IND review
  • FDA actions

Maintenance of INDs

  • Structure and content of STED
  • Technical file vs design dossier

Identifying recent changes

  • Examining accelerated review and breakthrough status
  • Paediatric legislation
  • Financial disclosure
  • Clinical trial transparency
  • Exclusivity and patent declaration

Workshop: Optimising your meetings

  • An overview of the different types of FDA meetings
  • Create a best practice guide for FDA meetings

Programme day two

Identifying the NDA types and categories

  • What is a full NDA?
  • 505(b)(2) applications
  • CTD requirements
  • FDA approach to CTD format
  • Review approach
  • Biologics and biosimilars (BLA)

Review of ANDA/NDA

Understanding ANDA classification

  • Examining paragraph I-IV
  • Overview of GDUFA

US change control – amendments

  • NDA/ANDA amendments
  • SUPAC/BACPAC guidance
  • Annual reports/CBE and PAS applications
  • NDA annual report requirements

Obtaining information from the FDA

  • Access to Federal Register
  • FOIA
  • FDA homepage

Final discussion and review of day

Presenters

Andrew Willis

An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.

His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.

Since acting as an independent consultant his roles have included:
  • Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
  • Orphan drug registrations of vaccine products and synthetic molecules
  • NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
  • Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
  • Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
  • Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.

Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -

  • Strategic management of ATMP products for Biotech start-up company
  • Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
  • Global Quality Leadership Team, providing oversight and direction for global quality processes.
  • Innovation Team, providing oversight and direction for the innovation.

Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.

Andrew Willis

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

19-20 Sep 2019
19-20 Sep 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 9 Aug*
Enrol now
12-13 Mar 2020
12-13 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
21-22 Sep 2020
21-22 Sep 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

* Note the early booking discount cannot be combined with any other offers or promotional code

Previous customers include...

  • Ablynx NV
  • Allergan Ltd
  • Almac Group Ltd
  • argenx BVBA
  • AstraZeneca
  • Auden McKenzie Group
  • Biogen Idec Inc.
  • Cheplapharm Arzneimittel GmbH
  • DSTL
  • Eli Lilly Regional Operations GmbH
  • Futura Medical
  • Galderma R&D
  • Gilead Sciences
  • Grünenthal GmbH
  • Hookipa Biotech AG
  • ImmuPharma
  • Leo Pharma A/S
  • MedImmune Limited
  • Medivir AB
  • Merck KGaA
  • Molnlycke Healthcare
  • NDA Regulatory Science Ltd
  • Orion Corporation Orion Pharma
  • Pharma Mar, S.A.
  • Pharmarov Consulting
  • Pharmathen S.A
  • Research and Markets
  • UCB
  • Valeant Pharma Poland Sp. z o.o.
  • Zambon SpA

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

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

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

One of the best speakers I have met so far. Excellent course due to an excellent speaker.

Aikaterini Sakka, Legal Expert, Pharmathen S.A

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

Good value for money

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

Excellent and what I had hoped for

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

Very clear content, excellent useful course and very knowledgable speaker

Claudia Williams, Senior Project Manager, Neem Biotech Ltd

Very good presentations

Natalie De Jonge, Regulatory Affairs Manager, argenx BVBA

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.

All good

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

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

Brilliant course, great speaker with excellent engagement

Jibran Ahmad, Senior Associate II, Biogen Idec Inc.