Module 1 – Introduction to Regulatory Affairs
Module 2 – The Common Technical Document (CTD)
Module 2 – The Common Technical Document (CTD)
- Duration: ~15 minutes
- Learning outcomes:
- Understand the role of regulatory affairs in life sciences.
- Recognise why regulation is essential for medicines, devices, and healthcare products.
Module 2 – The Common Technical Document (CTD)
Module 2 – The Common Technical Document (CTD)
Module 2 – The Common Technical Document (CTD)
- Duration: ~30 minutes
- Learning outcomes:
- Explore the structure of the CTD dossier.
- Understand the purpose of Modules 1–5.
- Identify the role of assessors and regulatory professionals in dossier preparation.
Module 3 – Chemistry, Manufacturing and Controls (CMC)
Module 3 – Chemistry, Manufacturing and Controls (CMC)
Module 3 – Chemistry, Manufacturing and Controls (CMC)
- Duration: ~45 minutes
- Learning outcomes:
- Understand the role of Chemistry, Manufacturing and Controls (CMC) in regulatory submissions.
- Recognise how Quality data supports the authorisation of medicines.
- Explore how assessors review CMC and Quality sections of the CTD (Module 3).
Module 4 – Gene and Cell Therapy in Regulatory Affairs
Module 3 – Chemistry, Manufacturing and Controls (CMC)
Module 3 – Chemistry, Manufacturing and Controls (CMC)
- Duration: ~1 hour
- Learning outcomes:
- Understand what gene therapies, cell therapies, and ATMPs are.
- Explore the unique regulatory challenges of advanced therapies (complex manufacturing, variability, stability).
- Recognise the additional data requirements for Module 3 (Quality) in ATMP submissions.
- Understand how regulators evaluate safety, efficacy, and long-term follow-up for patients.