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The 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?
- Pharmaceutical medicine and documents
- Introduction to CTD, ICH and eCTD
- Introduction to data standards relevant to module 3 (incl. EMA SPOR, ISO-IDMP)
The importance of chemistry/manufacturing and controls (CMC)
- Setting the scene for the module 3 deep-dive
Assessment of biologics and why the CMC section for these products is more extensive
A deep-dive in Module 3 – examining the content of all sections
- Module 3.2 for the substances (32S)
- Module 3.2 for the final products (32P)
- Appendices and regional information in Module 3 (32A and 32R)
- Additional data for generics in the US (ANDA tables)
- Process validation deep-dive (S25 + P35)
- Comparability across batches (ICH Q5E)
- Quality-by-Design and Quality Target Product Profile (ICH Q8, Q9 and Q10)
- Analytical method deep-dive (ICH Q2 and beyond)
- Process analytical technology
- Pharmaceutical quality system (ICH Q10)
Post-approval maintenance
- What and why?
- EU eCTD lifecycle management
- US eCTD lifecycle management
- Product lifecycle management (ICH Q12) and established conditions
Potential scenario’s for Module 3
- EDQM certificate of suitability of monographs of European pharmacopeia (CoS/CEP)
- Active substance master file (ASMP)
- US drug master files (DMFs)
Basic principles for eCTD authors (incl. focus on global dossier roll-out)
- Separating content from contexts
- Applying the right document granularity
- Lean and structured authoring
Trends, developments and future outlook
- Identification of medicinal products (IDMP)
- FDA Knowledge-Aided-Structured-Assessment and Structured-Application (FDA-KASA)
- FDA Pharmaceutical quality/Chemistry manufacturing and control (PQ/CMC) data elements
- EMA Digital Application Dataset Integration (DADI) project
- Accumulus synergy – global information exchange platform
Summary of Module 3 and what should stand out from the Quality Overall Summary (module 2)
Presenters
Hans van Bruggen (More...)
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...)
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).
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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18-19 Jul 2022 Live webinar 09:00-17:00 UK (London) |
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18-19 Jul 2022 Live webinar 09:00-17:00 UK (London) |
GBP 1,299.00 EUR 1,859.00 USD 2,098.00 + VAT @ 20.00% |
Enrol now
to attend Live webinar |
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28-29 Nov 2022 Live webinar 09:00-17:00 UK (London) |
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28-29 Nov 2022 Live webinar 09:00-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 24 Oct* |
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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.