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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.

28-29 Nov 2022

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Details

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

Who should attend

  • Senior analytical chemists
  • Formulation chemists
  • Technical services chemists
  • Registration staff (all levels)
  • Quality managers
  • Quality control directors
  • R&D project managers

Programme

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)

Presenters

Hans van Bruggen (More...)

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 (More...)

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).

Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
28-29 Nov 2022
Live webinar
09:00-17:00
UK (London)
28-29 Nov 2022
Live webinar
09:00-17:00
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 24 Oct*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Actelion Pharmaceutical Ltd
  • ALK-Abelló A/S
  • Beaphar B.V.
  • BIAL - Portela & C.ª, S.A.
  • Bilthoven Biologicals
  • CP Pharmaceuticals Ltd
  • Ebewe Pharma
  • EirGen Pharma Limited
  • Elanco Animal Health
  • ELPEN Pharmaceutical Co. Inc.
  • Fortune Pharmacal Company Limited
  • Furtado Consultancy Limited
  • Galapagos
  • GE Healthcare Limited
  • Genethics Regulatory Services Ltd
  • Ginsana
  • GlaxoSmithKline Vaccines & Diagnostics s.r.l.
  • GSK Consumer Health Care
  • HHV Biotech
  • ImmuPharma
  • Johnson & Johnson
  • LEO Pharma A/S
  • LINK Medical ApS
  • Masters Speciality Pharma
  • Medreich Plc
  • Nestec SA
  • Orphan Europe
  • PHARA+
  • Thermofisher Scientific Limited
  • Valeant Pharma Poland sp.z o.o

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 22

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, Jul 21

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 19

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, Dec 19

Great speaker, capable of transmitting his knowledge in an enjoyable and interactive way.

Rocio Arias, Regulatory Affairs Technician , Pharmex Advanced Laboratories, S.L., Dec 19

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 19

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, Jul 19

Excellent!

Vilma Smith, Senior Manager, Global Regulatory CMC, Bristol Myers Squibb, Jul 19

Good speaker, updated information and good discussions. The group assignments were terrific for learning and understanding.

Hilde Reiersen, Research Scientist, GE Healthcare AS, Jul 19

Excellent speaker! Good interaction! Wonderful course.

Marjana Grønvall, Regulatory affairs professional, ALK-Abelló A/S, Dec 18

Superbly knowledgable speaker and great training style - content was very helpful

Andrew Germain, Associate Director, CMC Regulatory Affairs, GW Pharmaceuticals, Dec 18

Very clean. Very clear speaker. Presentation and content are well adapted.

Sonia Bchir Kassassi , Regulatory Affairs CMC Expert, GUERBET, Jul 18

Very lively presentation, interactivity, exercises to keep the interest.

Natacha Gonzalez, CMC Dossier & Compliance Specialist, Ares Trading S.A., Jul 18

I really enjoyed the presentation, which I found really interesting.

Maria Biri, CMC Dossier Development & Coordination Supervisor, ELPEN Pharmaceutical Co. Inc., Dec 17

Experienced speaker

Julie de Smet, Regulatory Affairs Consultant, PharmaVize NV, Dec 17