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Common Technical Document (London, United Kingdom - December 1-2, 2020)

  • ID: 4992297
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: December 1-2, 2020
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A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

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 the 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
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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 the 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 a ten-stage plan for developments
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  • Andrew Willis Mr Andrew Willis,
    Consultant ,

    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. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and 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 has 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 currently has a total of 28 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. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.

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- 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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Rembrandt Hotel
11 Thurloe Pl,
United Kingdom


The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

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