Presented by
Management Forum
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
★★★★★ "very good, well organized"
12-13 March 2024
+ 2-3 July 2024, 25-26 November 2024 »
from £1099
This interactive two-day course will provide you with a clear and comprehensive understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of the EU and USA. Furthermore, the course examines the requirements for global roll-out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories.
You will increase your ability to manage all aspects of development of the CMC applications after two days of intensive lectures, group work and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.
Skills you will gain include:
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
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
12-13 March 2024
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 13543
Until 06 Feb
Not ready to book yet?
for 7 days, no obligation
2-3 July 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 13763
Until 28 May
Not ready to book yet?
for 7 days, no obligation
25-26 November 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 14045
Until 21 Oct
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.
very good, well organized
Nov 28 2022
Evdoky Harran
Regulatory Affairs Associate, Pierre Fabre
Nov 28 2022
Very good
Richa Dcruz
officer, Shorla Oncology
Jul 18 2022
Content is well designed and flowing the step by step informative topics. Presentation - well presented and weighed on important sections. Speaker - very interactive and made easy to understand. He is taking interest to answer the questions until I was clear about topics. He has focused on the key sections and explained in details about it. Interactive sessions are really good and keep my self engaged throughout the training.
Nikhil Soni
Regulatory Affairs Specialist, Thermofisher Scientific Limited
Jul 18 2022
The speaker has the required knowledge for the course as well as a wide experience. In general all the webinar was interesting.
Isabel Villanueva Gonzalez
regulatory affairs technician, Zendal
Jul 6 2021
An excellent 2 days - required lots of concentration but worth it. It was very engaging and encouraged me to continue learning and improving.
Jane Kean
Regulatory Associate, Elanco UK AH Limited
Dec 4 2019
The speaker is really an expert on the CTD requirements and teaches the mindset required to make up a good dossier. I learned a lot from this course.
Wendy Masman
Regulatory Affairs Officer, Beaphar B.V.
Dec 4 2019
It was one of the best workshops I have attended: content was according to expectations, all questions were answered, presenter was passionate and kept the energy high during the presentations.
Iris Vanwelkenhuysen
CMC Dossier Leader, Galapagos
Dec 4 2019
Great speaker, capable of transmitting his knowledge in an enjoyable and interactive way.
Rocio Arias
Regulatory Affairs Technician , Pharmex Advanced Laboratories, S.L.
Dec 4 2019
Excellent presentation by a first-class speaker who has a wealth of knowledge. I particularly liked the interactive exercises.
Wil Pantin
New Product Introduction Manager, M & A Pharmachem Ltd
Jul 3 2019
Good speaker, updated information and good discussions. The group assignments were terrific for learning and understanding.
Hilde Reiersen
Research Scientist, GE Healthcare AS
Jul 3 2019
Excellent!
Vilma Smith
Senior Manager, Global Regulatory CMC, Bristol Myers Squibb
Jul 3 2019
The speaker was not only very professional, but also kept the mood light and fun. I enjoyed his way of putting things into perspective and making me think in a whole other way from what I am used to. The exercises ... helped with better understanding the material. Overall, a really good course and a great speaker giving both theoretical and practical tools to understand the CTD and importance of the Module 3.
Joanna Sadiq
Regulatory Manager, LINK Medical ApS
Dec 4 2018
Superbly knowledgable speaker and great training style - content was very helpful
Andrew Germain
Associate Director, CMC Regulatory Affairs, GW Pharmaceuticals
Dec 4 2018
Excellent speaker! Good interaction! Wonderful course.
Marjana Grønvall
Regulatory affairs professional, ALK-Abelló A/S
Jul 4 2018
Very lively presentation, interactivity, exercises to keep the interest.
Natacha Gonzalez
CMC Dossier & Compliance Specialist, Ares Trading S.A.
Jul 4 2018
Very clean. Very clear speaker. Presentation and content are well adapted.
Sonia Bchir Kassassi
Regulatory Affairs CMC Expert, GUERBET
Dec 5 2017
The content of presentation was very good and covered the major sections of CTD. The speaker was very keen to answer all questions.
Ewelina Dulko
Senior Formulation Scientist, Wockhardt
Dec 5 2017
Very interactive course. Very interesting.
Fanny Valleix
Head Clinical Research, ImmuPharma
Jul 5 2017
High quality training, speaker is really good with a lot of experience. Very useful information and advice shared with the group.
Slobodanka Cirin-Varadjan
Regulatory Affairs, Hemofarm A.D.
Jul 5 2017
Very detailed and informative. Speaker clearly very knowledgable on experiences and delivered the content in a clear and concise manner. Excellent transfer of information.
Ini Okereke
Regulatory Affairs Manager, GW Pharmaceuticals
Jul 5 2017
Brilliant
Camilla Costa
Regulatory Affairs Manager, Masters Speciality Pharma
Dec 5 2017
I really enjoyed the presentation, which I found really interesting.
Maria Biri
CMC Dossier Development & Coordination Supervisor, ELPEN Pharmaceutical Co. Inc.
Jul 5 2017
It is very good. I'm very glad that my company sent me on this course.
Nette Boylan
Regulatory Officer, CMC, Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd
Jul 5 2017
Very professional
Evdoky Harran
Regulatory Affairs Associate, Pierre Fabre
Dec 5 2017
Experienced speaker
Julie de Smet
Regulatory Affairs Consultant, PharmaVize NV
Dec 14 2016
Overall information and guidance provided have been very useful and have been applied in my day to day work experience
Venita Furtado
Regulatory Consultant, Furtado Consultancy Limited
Dec 14 2016
The course content was extended so that not all the issues were discussed in-depth because there was not time, but the discussed parts and the approach used were excellent.
Laura Zecca
Scientific Coordination Officer, Ginsana
Dec 14 2016
Overall, the course is great and even better than I expected. I will definitely apply what I learned to my daily work.
Ying Zhao
Quality Assurance Manager, Genethics Regulatory Services
Jun 14 2016
Content of the course was as expected but a little too extensive for just 2 days, presentation was interesting and speaker professional and motivating
Gordana Sijan Zidaric
Regulatory Affairs Officer, Xellia Ltd
Jun 14 2016
On overall, the presentation was given in a proper organised way with more practical approach. I admire the speaker and his knowledge about the subject
Archana Sekharan
Regulatory Affairs Executive, Genethics Regulatory Services
Dec 14 2016
As stated above, I was very satisfied about the quality of the speaker, content of the course, structure, fact that there were some practical exercises, interactivity of the course.
Jan Luypaert
Regulatory Affairs Manager, PhaRA
Jun 14 2016
I have never attended a course with so few participants, but I actually liked and it made it easier to communicate, and also it forced us to be more proactive. Andrew Willis was very clearr in his presentations, but again many of these went very fast.
Nermin Ipek
Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc
Jun 14 2016
A course that is of value for a range of experiences, thank you
Robert Ellis
Principal Consultant CM&C, Elanco Animal Health
United Kingdom
Switzerland
Denmark
Sweden
France
Ireland
Belgium
Netherlands
Spain
Croatia
Germany
Italy
Norway
Slovak Republic
Austria
Bulgaria
Greece
Hong Kong
Hungary
Israel
Lebanon
Poland
Serbia
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: