Presented by
Management Forum
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"
14-15 June 2023
+ 2-3 October 2023
from £1099
- 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
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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.
The The FDA Drug Approval Process course will cover:
Pharmaceutical Medicine and Documents
- The role of regulatory affairs
- The purpose of the Common Technical Document (CTD)
FDA History and Organisation
- Review of FDA centers
- Organization of the CDER and CBER
- Differences between CDER and CBER
Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)
- 21st century cure act
- Patent and exclusivity
- PDUFA
- GDUFA
- BsUFA
Legal Basis Continued
Application and Submissions Types
- Investigational new drugs (IND)
- New drug applications (NDA)
- Abbreviated new drug applications (ANDA)
- Over the counter drugs (OTC)
- Biologics license applications (BLA)
- Orphan drug designations
Refusal to File
- Reasons for refusal
- The regulatory process
Investigational New Drug (IND) Applications
- Review of the content of an IND
Getting Products to the Market Faster
- Review of expedited programs in the US
- Fast Track designation
- Breakthrough Therapy designation
- Accelerated Approval
- Priority Review designation
FDA Meetings and Documentation
- FDA communication philosophy
- Different meeting types
- Scope
- Format
- Procedure
CTD Content - Setting the Scene
- Lean authoring to ensure possible document re-use for multiple purposes
- A review of the different modules
CTD Content - M1
CTD Content - M3 and Corresponding M2
CTD Content - M4 and Corresponding M2
CTD Content - M5 and Corresponding M2
Submission Format and Methods
- Study tagging files
- Datasets
- Case report forms
- Bioresearch monitoring (BIMO) clinical data
US Amendment Procedures
- A review of US amendment procedures (incl. annual reports, minor/major changes)
High Level Comparison US vs EU
- A review of the main differences in terms of dossier content and procedures
Case Study
14-15 Jun 2023
2-3 Oct 2023
Hans van Bruggen
Qdossier
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.
2-3 Oct 2023
Marloes van der Geer
Qdossier
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).
14-15 Jun 2023
Sara Magalhães
Qdossier
Sara Magalhães works as Regulatory Affairs Consultant at Qdossier, a Celegence company. She provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products.
Sara holds a master in Pharmaceutical Sciences from the Faculty of Pharmacy of the University of Lisbon, Portugal. Working at Qdossier for 2 years, Sara first acted as a Regulatory Operations Associate, being part of data management and migration projects as well as publishing, compiling and submitting eCTD and NEEs dossiers. As Regulatory Affairs consultant, she provides, amongst other, procedural advice, guidance and document review for new marketing authorisation applications.
Sara’s areas of expertise are: regulatory affairs, market approval procedures, regulatory convergence & harmonization, data management regulatory initiatives and eCTD publishing and lean authoring.
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*
Please contact us for pricing if you are interested in booking 5 or more delegates
14-15 June 2023
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12216
- GBP 1,299
- EUR 1,869
- USD 2,129
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
2-3 October 2023
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12323
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 28 Aug
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* 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
Good webinar focused on various stages of the FDA drug/device approval process.
Oct 10 2022
Jillian Green 
Assistant Regulatory Operations Manager, Kalvista Pharmaceuticals
Sep 20 2021
Very informative and good.
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
- Tay Therapeutics
- Terumo BCT
- Torbay Pharmaceuticals
Belgium
- Ablynx NV
- Ardena
- argenx BVBA
- GALAPAGODS NV
- Galapagos NV
- SGS Belgium NV
- Terumo BCT Europe N.V.
- UCB
Germany
- Bavarian Nordic
- Boehringer Ingelheim Ltd
- Boehringer Ingelheim Vetmedica GmbH
- Cheplapharm Arzneimittel GmbH
- Grünenthal GmbH
- Helm AG
- Life Molecular Imaging
- Merck KGaA
Sweden
- AstraZeneca
- Camurus AB
- Hansa Medical AB
- Medivir AB
- Swedish Orphan Biovitrum AB
- Swedish Orphan Biovitrum AB (publ)
France
- BlueReg
- DBV Technologies
- Galderma R&D
- ImmuPharma
- LFB Biomedicaments
Spain
- Grifols S.A
- Grifols, S.A.
- Noucor Health, S.A.
- Pharma Mar, S.A.
Switzerland
- Bayer Consumer Care AG
- DNDi
- ObsEva SA
- Sintetica SA
Greece
- ELPEN PHARMACEUTICAL CO. INC.
- Genepharm SA
- Pharmathen S.A
Netherlands
- Galapagos
- Merus NV
- Sever Pharma Solutions
Austria
- Eli Lilly Regional Operations GmbH
- Hookipa Biotech AG
Denmark
- LEO Pharma
- Leo Pharma A/S
Italy
- SKILLPHARMA S.r.l.
- Zambon SpA
Poland
- Bausch Health Poland Sp. z o.o.
- Valeant Pharma Poland Sp. z o.o.
Croatia
- Xellia d.o.o.
Finland
- Orion Corporation Orion Pharma
Hungary
- Gedeon Richter
Ireland
- Noden Pharma DAC
Latvia
- AS Kalceks
Portugal
- BIAL - Portela & C.ª, S.A.
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 experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
