Event info
Date:16 Aug
Time:08:30 - 11:00
Venue:Medicon Valley Alliance, Copenhagen
Contact person
Louise Fur Høier

Louise Fur Høier

Event Manager & PA to CEO

MVA Good Morning Meeting – Bioanalytical Method Validation and Study Sample Analysis

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

 

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Program

8:30Networking, registration and light breakfast
9:00Welcome
David Munis Zepernick, Head of Member Engagement and Communication, Medicon Valley Alliance
9:05BioAgilytix Introduction
Ymke van der Geld, Director Business Development Scandinavia, BioAgilytix
9:15ICH M10 guidelines; what is new and explore the impact
Marianne Scheel Fjording, MSc, Ph.D., Scientific Officer Executive Director, BioAgilytix
10:00Q&A
10:30Networking
11:00End of Good Morning Meeting

 

Speaker

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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