Common Technical Document

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

2-3 Jun 2020

& 1-2 Dec 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,339 2,027 *
* When you book before 1 May

Book now

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 marketsof 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 day one

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

Programme day two

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


Andrew Willis

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.

Book now

2-3 Jun 2020
2-3 Jun 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,027.00
Until 1 May*
Enrol now
1-2 Dec 2020
1-2 Dec 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd
  • Ares Trading S.A.
  • Biovet JSC
  • Bracco Suisse SA
  • Ebewe Pharma
  • Ferring Pharmaceuticals Inc
  • Fortune Pharmacal Company Limited
  • GE Healthcare AS
  • GE Healthcare Limited
  • Genethics Regulatory Services Ltd
  • GlaxoSmithKline Vaccines & Diagnostics s.r.l.
  • GW Pharmaceuticals
  • LINK Medical ApS
  • M & A Pharmachem Ltd
  • Medreich Plc
  • MSD
  • Nestec SA
  • Niacet b.v.
  • Novo Nordisk A/S
  • PHARA+
  • Pharmavize (Ardena)
  • Pharmex Advanced Laboratories, S.L.
  • Pierre Fabre Medicaments
  • Recipharm
  • Recipharm Pharmaceutical Development AB
  • Sanofi-Aventis Deutschland GmbH
  • Teva UK Ltd
  • Valeant Pharma Poland sp.z o.o
  • Wockhardt (UK) Ltd
  • Zentiva Group a.s.

Excellent speaker! Good interaction! Wonderful course.

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

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

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

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

Sonia Bchir Kassassi , Regulatory Affairs CMC Expert, GUERBET

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

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

Experienced speaker

Julie de Smet, Regulatory Affairs Consultant, PharmaVize NV

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

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

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

Very interactive course. Very interesting.

Fanny Valleix, Head Clinical Research, ImmuPharma


Camilla Costa, Regulatory Affairs Manager, Masters Speciality Pharma

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

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.

Very professional

Evdoky El Harran, Regulatory Affairs Associate, Pierre Fabre Medicaments

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

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

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

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

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

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

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

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

A course that is of value for a range of experiences, thank you

Robert Ellis, Principal Consultant CM&C, Elanco Animal Health