European Biomanufacturing Summit 2022

As a proud sponsor of the European Biomanufacturing Summit 2022, we welcome you to join us virtually from February 8 – 10 where you will meet with our subject matter experts at a hosted workshop during the main event.

Learn more from our Subject Matter Experts on the following hot topic:

Entering First-In-Human Clinical Trials: Considerations for a Robust Regulatory CMC Package
Michele Duggan
Sr Manager, Regulatory Affairs

Michele Duggan
Daniela Decina
Sr Director, Regulatory Affairs

Daniela Decina

Join our Subject Matter Experts to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan.


• How to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules
• Preparing your organization to enter the clinical trial stage of your molecule’s development
• Developing knowledge of critical quality attributes to justify the manufacturing and control strategy
• Establishing a dossier to support chemistry, manufacturing, and controls (CMC)
• Providing health authorities with the information to assess the quality of material entering the clinical trial
• Avoiding delays caused by inadequate CMC supportive evidence or detail
• Planning for continuing development and considering scientific advice on path to approval

The European Biomanufacturing Summit brings together innovative, exciting, and timely content delivered by today’s top minds within the biomanufacturing industry.

Request a meeting

Please fill out the form below or press submit if you're a return visitor to our site.