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 products 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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
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
Day 2
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)
Speakers
Mr Andrew Willis,
Consultant ,
IndependentAndrew 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.
Who Should Attend
- Senior analytical chemists
- Formulation chemists
- Technical services chemists
- Registration staff (all levels)
- Quality managers
- Quality control directors
- R&D project managers
