Presented by
Management Forum
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
★★★★★ "The speaker was excellent, with a lot of knowledge and experience. I really liked the examples on wh... more (35)"
25-26 November 2024
+ 11-12 March 2025, 7-8 July 2025, 24-25 November 2025 »
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 training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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.
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
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
Limited places remaining
Not ready to book yet?
for 7 days, no obligation
11-12 March 2025
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 14577
Until 04 Feb
Not ready to book yet?
for 7 days, no obligation
7-8 July 2025
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 14808
Until 02 Jun
Not ready to book yet?
for 7 days, no obligation
24-25 November 2025
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 15090
Until 20 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; and apply only when booking multiple delegates on the same date.
The speaker was excellent, with a lot of knowledge and experience. I really liked the examples on which we practised what needs to be included in some CTD dossier.
Mar 12 2024
Martina Kunštić
RA Specialist , Genera Inc./Dechra Pharmaceuticals
Mar 12 2024
The webinar has great content for us who work with CTD's in the pharma industry, I think there was so much helpful information on this for beginners and medium level on CTD. I think Andrew is great and gives a truly expert opinion, he demonstrated his expertise and really had you thinking.
Gabriela Gutierrez
International Regulatory Affairs Specialist, Zeyco
Nov 28 2022
very good, well organized
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
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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: