The New ICH M10 Guidelines
A critical component of the regulatory decision regarding the efficacy and safety of therapeutic products is the bioanalytical concentration of therapeutic products in biological matrices. Therefore, it is imperative that the bioanalytical methods used are well characterized, validated, and documented to best support regulatory decisions.
Explore the new ICH M10 guidelines on the bioanalytical landscape with one of the Members of the Expert Working Group for ICH M10 Marianne Scheel Fjording, MSc, Ph.D., Scientific Officer Executive Director, BioAgilytix.
The presentation will touch upon topics such as:
- What is new compared to the current FDA and EMEA guidelines
- Explore the impact on your organization
Date: Tuesday, August 16th 2022
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome David Munis Zepernick, Head of Member Engagement and Communication, Medicon Valley Alliance |
| 9:05 | BioAgilytix Introduction Ymke van der Geld, Director Business Development Scandinavia, BioAgilytix |
| 9:15 | ICH M10 guidelines; what is new and explore the impact Marianne Scheel Fjording, MSc, Ph.D., Scientific Officer Executive Director, BioAgilytix |
| 10:00 | Q&A |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Speaker
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Marianne Scheel Fjording Scientific Officer, Executive Director, BioAgilytix Labs.
Marianne Scheel Fjording, MSci, PhD, is Scientific Officer, Executive Director at BioAgilytix Labs. Prior to joining BioAgilytix she was Scientific Director at Novo Nordisk, Denmark where she worked with regulated assay validation. Her experience is within Large Molecules. Marianne is member of the EWG for the ICH M10 as a representative for PhRMA. Marianne has a Master of Science degree in biochemistry from Copenhagen University, and a PhD in intracellular signaling. Marianne has over 25 years of experience within pharmaceutical companies.
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