Presented by
Management Forum
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 (20)"
6-7 February 2024
+ 12-13 June 2024, 14-15 October 2024 »
from £1099
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:
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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.
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.
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).
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
6-7 February 2024
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13512
Until 02 Jan
Not ready to book yet?
for 7 days, no obligation
12-13 June 2024
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 13707
Until 08 May
Not ready to book yet?
for 7 days, no obligation
14-15 October 2024
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 13917
Until 09 Sep
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.
A good, detailed process of FDA drug approval process
Oct 2 2023
Richa Dcruz
officer, Shorla Oncology
Jun 14 2023
Very good webinar I am glad I was able to attend.
Magdalena Olszewska
Sr. Director RA EMEA, Bausch Health Poland Sp. z o.o.
Oct 10 2022
Good webinar focused on various stages of the FDA drug/device approval process.
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
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2 days
Typical duration
Pricing from:
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:
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: