Common Technical Document

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

3-4 Jul 2019

& 4-5 Dec 2019

GBP 1,499
EUR 2,099
USD 2,339

Book now

Course Overview

This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for global roll out of the document 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 session, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.

This course will cover the following topics:

  • Effective compilation of CTD and critical review of documentation
  • Quality by design, 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 development and quality aspects of your developments and registration dossier in Europe and US
  • Ensuring right first time development
  • Meeting the legal framework and guidelines for the CMC/quality part of the document, and links to GMP

Why you should attend

This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of 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 aspects of 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.

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 Understanding ICH

  • Assessing the impact of the 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, other methods
  • European Submissions, CEP and ASMF requirements
  • Detailed information requirements for the section
  • Q11 explained – EU and US expectations of FMEA analysis
  • Development expectations and scale-up requirements
  • Specific examples on 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

  • The case study will allow participants to 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

(All Module Sections include Example Sections for Writing)

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
  • Examining the content of the section

Writing the sections on Excipients and Packaging Components

  • Control of the Excipients/Packaging Components
  • Examples of data expectations
  • Examining maintaining 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

The function and content of the Quality Overall Summary

  • 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 CTD – Module 3

Examining Change Control – Practical tips

Practical Exercise in Generic Development

  • Identifying 10 – stage plan for developments

Presenter

Andrew Willis

An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.

His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.

Since acting as an independent consultant his roles have included:

  • Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
  • Orphan drug registrations of vaccine products and synthetic molecules
  • NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
  • Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
  • Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
  • Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.

Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -

  • Strategic management of ATMP products for Biotech start-up company
  • Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
  • Global Quality Leadership Team, providing oversight and direction for global quality processes.
  • Innovation Team, providing oversight and direction for the innovation.

Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.

Book now

3-4 Jul 2019
3-4 Jul 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
Enrol now
4-5 Dec 2019
4-5 Dec 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
Enrol now

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  • Teva UK Ltd
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  • Wockhardt (UK) Ltd

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

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

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

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 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

Brilliant

Camilla Costa, Regulatory Affairs Manager, Masters Speciality Pharma

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

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, 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

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

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

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

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