CMC (Chemistry, Manufacturing and Controls) is one of the most important activities in drug product development. It occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product. CMC is a critical component of all pharmaceutical products that cannot be overlooked. To get approval of a new biopharmaceutical drug also the chemistry, manufacturing and control (CMC) module (Module 3 – The Quality section of the CTD) is of vital importance.
What should you consider at what stage during drug development? How to prevent delays and costs in regulatory approval as a result of incomplete CMC sections? When to start as a young company with the CMC dossier and how to collaborate with CMC experts? Experts from consultancy and biotech companies will share their insights and experiences.
Presented by experts Albert Mekking, Managing Consultant at Progress – Experts in Life Sciences and Robert Doornbos, VP Manufacturing and Non-Clinical Development at Merus.
Date & Time:
Friday September 19, 2025
13:00 – 18:00 hrs.
Venue:
Dotslash, Utrecht
Participation:
Registration is needed to attend!
Please send an e-mail to miranda.de.regt@iventus.nl to receive your confirmation and additional final information.
Please note: limited number of places available! Availability on first-come, first-served basis.
- LifeSciences@Work Expert Classes are small-scale, targeted live workshops organized in close collaboration with industry and experts.
- Expert Classes are primarily intended for Venture Challenge alumni. We also warmly welcome other early-stage startups, provided their innovation aligns with the focus of the Venture Challenge: drug development, medical technology, diagnostics, and enabling technologies. The sessions are tailored to companies in their first five years, offering practical insights into what you need to know and do as a startup when tackling a specific topic.
- University business developers are welcome, although startups will be given priority for participation.
- Participation is free of charge. Not sure if you belong to the target group? Feel free to contact us by e-mail.
This meeting is powered by Health~Holland