Presented by
Management Forum
The Common Technical Document Training Course
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
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course Overview
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:
- Effective compilation of the Common Technical Document (CTD) and critical review of documentation
- Quality by design (QbD), critical attributes and developing new product using the CQA pyramid model
- Compiling and submitting Module 3 (CTD) of your registration dossier
- Identifying the extent of content expected by EU and US regulators
- Achieving the quickest turnaround of your submission
- Managing the pharmaceutical and quality aspects of your developments and registration dossier in Europe and the US
- Ensuring right-first-time development
- Meeting the legal framework and guidelines for the CMC/quality part of the dossier and links to GMP
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.
Who should attend
- Senior analytical chemists
- Formulation chemists
- Technical services chemists
- Registration staff (all levels)
- Quality managers
- Quality control directors
- R&D project managers
The The Common Technical Document course will cover:
What is the CTD?
- Pharmaceutical medicine and documents
- Introduction to CTD, ICH and eCTD
- Introduction to data standards relevant to module 3 (incl. EMA SPOR, ISO-IDMP)
The importance of chemistry/manufacturing and controls (CMC)
- Setting the scene for the module 3 deep-dive
Assessment of biologics and why the CMC section for these products is more extensive
A deep-dive in Module 3 – examining the content of all sections
- Module 3.2 for the substances (32S)
- Module 3.2 for the final products (32P)
- Appendices and regional information in Module 3 (32A and 32R)
- Additional data for generics in the US (ANDA tables)
- Process validation deep-dive (S25 + P35)
- Comparability across batches (ICH Q5E)
- Quality-by-Design and Quality Target Product Profile (ICH Q8, Q9 and Q10)
- Analytical method deep-dive (ICH Q2 and beyond)
- Process analytical technology
- Pharmaceutical quality system (ICH Q10)
Post-approval maintenance
- What and why?
- EU eCTD lifecycle management
- US eCTD lifecycle management
- Product lifecycle management (ICH Q12) and established conditions
Potential scenario’s for Module 3
- EDQM certificate of suitability of monographs of European pharmacopeia (CoS/CEP)
- Active substance master file (ASMP)
- US drug master files (DMFs)
Basic principles for eCTD authors (incl. focus on global dossier roll-out)
- Separating content from contexts
- Applying the right document granularity
- Lean and structured authoring
Trends, developments and future outlook
- Identification of medicinal products (IDMP)
- FDA Knowledge-Aided-Structured-Assessment and Structured-Application (FDA-KASA)
- FDA Pharmaceutical quality/Chemistry manufacturing and control (PQ/CMC) data elements
- EMA Digital Application Dataset Integration (DADI) project
- Accumulus synergy – global information exchange platform
Summary of Module 3 and what should stand out from the Quality Overall Summary (module 2)
Hans van Bruggen
Celegence
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
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).
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
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
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 06 Feb
- 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 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
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 28 May
- 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
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
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 21 Oct
- 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 Common Technical Document training course
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
- Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd
- Bespak
- Bespak Europe Ltd
- Bristol Myers Squibb
- CP Pharmaceuticals Limited
- Elanco Animal Health
- Elanco UK AH Limited
- Ethypharm
- Furtado Consultancy Limited
- GE Healthcare Ltd.
- Genethics Regulatory Services
- GSK Consumer Health Care
- GW Pharmaceuticals
- GW Pharmaceuticals PLC
- Ipsen Ltd
- Lonza
- M & A Pharmachem Ltd
- Masters Speciality Pharma
- Medreich Plc
- Medreich Plc
- Morningside Healthcare Limited
- MSD
- Niacet b.v.
- Seqirus UK Ltd
- Teva UK Ltd
- Thermofisher Scientific Limited
- Torbay Pharmaceuticals
- Wockhardt
- Wockhardt UK Ltd
- Zentiva Group a.s.
Switzerland
- Actelion Pharmaceutical Ltd
- Advanced Accelerator Applications
- Ares Trading S.A.
- Bracco Suisse SA
- DNDi
- Emergent BioSolutions Berna GmbH
- Ginsana
- Nestec SA
- ObsEva SA
Denmark
- ALK-Abelló A/S
- Aurora Nordic Cannabis A/S
- Ferring Pharmaceuticals A/S
- Ferring Pharmaceuticals Inc
- LEO Pharma A/S
- LINK Medical ApS
- Novo Nordisk A/S
- UNION therapeutics
Sweden
- Camurus AB
- Fresenius Kabi
- Fresenius Kabi AB
- Liansa Pharma Consulting AB
- Recipharm
- Recipharm AB
- Recipharm Pharmaceutical Development AB
France
- Groupe Guerbet
- GUERBET
- ImmuPharma
- Maco Productions
- Orphan Europe
- Patheon France
Ireland
- EirGen Pharma Limited
- Genzyme Ireland Limited
- Genzyme Ireland Ltd
- Rottapharm Ltd
- Sanofi
- Shorla Oncology
Belgium
- argenx
- Galapagos
- PhaRA
- PHARA+
- PharmaVize NV
Netherlands
- Beaphar B.V.
- Bilthoven Biologicals
- HHV Biotech
- Johnson & Johnson
- Sever Pharma Solutions
Spain
- Faes Farma S.A.
- Grifols S.A.
- Instituto Grifols S.A
- Pharmex Advanced Laboratories, S.L.
- Zendal
Croatia
- Genera Inc
- Genera inc./Dechra Pharmaceuticals
- Xellia
- Xellia Ltd
Germany
- Aurora Europe GmbH
- Bayer AG
- Sanofi-Aventis Deutschland GmbH
Italy
- Chiesi farmaceutici
- GlaxoSmithKline Vaccines & Diagnostics s.r.l.
- Menarini Ricerche spa
Norway
- dne pharma AS
- GE Healthcare AS
- Weifa AS
Slovak Republic
- Ewopharma International s.r.o
- Ewopharma International sro
Austria
- Ebewe Pharma
Bulgaria
- Biovet JSC
Greece
- ELPEN Pharmaceutical Co. Inc.
Hong Kong
- Fortune Pharmacal Company Limited
Hungary
- Gedeon Richter Ltd
Israel
- NeuroDerm
Lebanon
- Pierre Fabre
Poland
- Valeant Pharma Poland sp.z o.o
Serbia
- Hemofarm A.D.
Run The Common Technical Document Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- 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:
