Date: Tuesday 13 June 2023
Time: 15:00–16:00 BST (GMT+1)/16:00–17:00 CEST
This session will discuss the importance of the CMC information and how the CMC information needs to be reflected "well" in several documents used in a clinical trial.
The importance of well reflecting the CMC details in any clinical documents is true for small molecules, but even more for complex CMC development like for biological medicines e.g. the ATMP (Advance Therapy Medicinal Products) and Cell Gene Therapy studies area.
We will discuss the importance of an early and efficient connection between the clinical team and the CMC team. Thanks to this fruitful connection, the complete, accurate and current CMC details are included in the documents used and submitted for clinical trials e.g. in the US and EU. This will enable the complete review of the CMC information by the health authorities prior to the start of a clinical trial and ensure patient safety. The life cycle management of these clinical documents should reflect accurately all CMC changes.
1. Recognize the important connection between CMC information and clinical documents and process.
2. Understand the risks if there is non-compliance because CMC details are not well reflected in clinical documents and process.
Gabriel Bohl, Pharm.D.
Dir, Regulatory CMC CGT/ATMP
• 25 years’ experience in International Regulatory Affairs across various therapy areas, with 20 years CMC experience and 15 years on large molecules – e.g. ATMP/CGT, GMOs and other biological Products.
• 3 Working experiences – 1) in a large pharmaceutical company, 2) in a health agency and 3) in CROs.
• Gap analysis, risk assessment and strategic input on CMC/pharmaceutical development with IMPD/MAA/(p)IND/BLA support, and life cycle management of medicinal products (e.g. variations & amendments).
• Working and interacting with international regulatory bodies (e.g. EU MS, US FDA, EU Ph Eur, EMA, WHO, Swissmedic, and others).
Imke Veltman, MSc
Ass. Dir, Dossier Development & Operations (CMC) at Janssen
• 15 years of experience in the pharmaceutical industry, of which 10 years in various Regulatory affairs roles in multiple smaller and bigger international pharma companies, across biological therapeutics and small molecules, including newer modalities such as oligonucleotides, and with focus on both CMC and clinical RA
• Worked on all stages of product development; IND/IMPD, MAA/NDA and life cycle management, including associated interactions with major health authorities (EMA, FDA, MHRA)
• Since 3 years employed in the Janssen R&D organisation as CMC Dossier Development expert, based in Leiden, the Netherlands
- TOPRA Members: Free
- Non-member: £45 (includes 2 months TOPRA membership)
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