Presented by
Management Forum

Common Technical Document

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

1-2 Dec 2021 + 3 more dates

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  • Format: Live online, Classroom
  • 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

Who should attend

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

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The Common Technical Document course will cover:

What is the CTD?

  • The road map to Module 3 and understanding ICH
  • Assessing the impact of harmonisation – ICH guidelines

Preparing the drug substance section of the application – US and EU

  • Analysing the needs for the section
  • How to submit information – drug master files, certificates of suitability (CEP) and other methods
  • European submissions, CEP and active substance master file (ASMF) requirements
  • Detailed information requirements for the section
  • Q11 explained – EU and US expectations of failure mode and effects analysis (FMEA)
  • Development expectations and scale-up requirements
  • Specific examples of EU/US format and guidance

GMP for active substances

  • Examining GMP requirements and EU and US expectations, inspection timing and interactions and contractual obligations

Case study: Essential information from API suppliers

  • Identify and understand the essential data requirements from API suppliers for submission of generic applications

Examining the content of the sections concerning the drug product composition and development of the drug product

  • Defining the formulation
  • Identifying the data needs for the pharmaceutical development section, explaining QbD and FMEA requirements
  • Multiple examples of development report content – practical for table of contents and creation of QbD pyramid

Writing the section on manufacture of the drug product and process validation

  • Examining the content of the section: how much information to provide
  • Defining the difference between process development and validation and looking at validation expectations in today’s environment

Writing the sections on excipients and packaging components

  • Control of the excipients/packaging components
  • Examples of data expectations
  • Examining the maintenance of these sections

Writing the sections on control of the finished product and case study

  • Examining the content of the section
  • Control of the drug product
  • Examples of specifications for multiple product types
  • Examples for method summaries

Writing the stability section

  • Examining the content of the section
  • Evaluation of stability data and the impact on shelf life

The function and content of the Quality Overall Summary (QOS)

  • Overview of the current approaches
  • What is the Expert Report: practical involvement of the expert
  • QOS explained and compared with Expert Report
  • Detailed content of the QOS

Examining global roll-out of Module 3

Examining change control – practical tips

Practical exercise in generic development

  • Identifying ten-stage plan for developments

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1-2 Dec 2021

Hans van Bruggen

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.

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1-2 Dec 2021

Marloes van der Geer

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).

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1-2 Dec 2021

Maikel Bouman

Maikel Bouman works as a Senior Regulatory Operations Manager at Qdossier and in his role he has a strong focus on managing Regulatory Operations, coordination, and development of staff; planning and coordination of projects, including regulatory filings of dossiers across various regions and development and maintenance of technical solutions supporting Regulatory Operations. Maikel has a broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation and dispatch of different types of electronic submission formats to various regulatory authorities such as the United States, Canada, Europe, Australia and Switzerland.



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Book Common Technical Document Live online/Classroom training

1-2 Dec 2021

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 11040

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 27 Oct

In your basket 

1-2 Feb 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11451

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 28 Dec

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

5-6 May 2022

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 11655

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 31 Mar

In your basket 

28-29 Nov 2022

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 11791

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 24 Oct

In your basket 

Reviews of IPI's Common Technical Document training course


An excellent 2 days - required lots of concentration but worth it. It was very engaging and encouraged me to continue learning and improving.

Jul 6 2021

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 El Harran
Regulatory Affairs Associate, Pierre Fabre Medicaments

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

UK

  • 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
  • Genzyme Ireland Limited
  • 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
  • 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
  • Ginsana
  • Nestec SA
  • ObsEva SA

Denmark

  • ALK-Abelló A/S
  • Aurora Nordic Cannabis A/S
  • Ferring Pharmaceuticals Inc
  • LEO Pharma A/S
  • LINK Medical ApS
  • Novo Nordisk A/S

Belgium

  • argenx
  • Galapagos
  • PhaRA
  • PHARA+
  • PharmaVize NV

France

  • Groupe Guerbet
  • GUERBET
  • ImmuPharma
  • Maco Productions
  • Orphan Europe

Sweden

  • Camurus AB
  • Liansa Pharma Consulting AB
  • Recipharm
  • Recipharm AB
  • Recipharm Pharmaceutical Development AB

Germany

  • Aurora Europe GmbH
  • Bayer AG
  • Sanofi-Aventis Deutschland GmbH

Ireland

  • EirGen Pharma Limited
  • Genzyme Ireland Ltd
  • Rottapharm Ltd

Norway

  • dne pharma AS
  • GE Healthcare AS
  • Weifa AS

Spain

  • Faes Farma S.A.
  • Grifols S.A.
  • Pharmex Advanced Laboratories, S.L.

Netherlands

  • Beaphar B.V.
  • Bilthoven Biologicals

Austria

  • Ebewe Pharma

Bulgaria

  • Biovet JSC

Croatia

  • Xellia Ltd

Greece

  • ELPEN Pharmaceutical Co. Inc.

Hong Kong

  • Fortune Pharmacal Company Limited

Hungary

  • Gedeon Richter Ltd

Israel

  • NeuroDerm

Italy

  • GlaxoSmithKline Vaccines & Diagnostics s.r.l.

Lebanon

  • Pierre Fabre Medicaments

Poland

  • Valeant Pharma Poland sp.z o.o

Serbia

  • Hemofarm A.D.

Slovak Republic

  • Ewopharma International sro

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy