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Common Technical Document Training Course
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
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?
- 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
Presenters
Hans van Bruggen (More...) (1-2 Dec 2021)
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...) (1-2 Dec 2021)
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).
Maikel Bouman (More...) (1-2 Dec 2021)
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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1-2 Dec 2021 Live webinar |
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1-2 Dec 2021 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 1 Nov* |
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to attend Live webinar |
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1-2 Feb 2022 Face-to-face, (venue not yet confirmed) |
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1-2 Feb 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 28 Dec* |
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to attend Face-to-face (venue not yet confirmed) |
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5-6 May 2022 Live webinar |
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5-6 May 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 31 Mar 22* |
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to attend Live webinar |
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28-29 Nov 2022 Live webinar |
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28-29 Nov 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 24 Oct 22* |
Enrol now
to attend Live webinar |
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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