EBF
EBF Focus
Spring

ICH M10 - Public consultation & Industry Feedback
Towards a Science based Global Bioanalytical Guideline


Hesperia Tower
Barcelona, Spain
20-22 May 2019

General

INTRODUCTION

Harmonization of Bioanalytical Guidance/Guidelines has been high on the agenda of our community the last 5 years. In recent years, we have seen important contributions from all regions and communities at conferences or in peer reviewed publications.  All agree that future guidelines should be built on science and experience, and consider technological advancements.

With the ICH M10 draft Guideline becoming available for comments very soon we take the opportunity to gather consolidated input in an open dialogue.

 

AIM OF THE WORKSHOP

The aim of the meeting is to discuss the draft ICH M10 guideline and, considering industry data and experience related to BMV and sample analysis, support the draft guideline and/or provide comments and areas for improvement.

The meeting agenda is currently being drafted. We plan to work in close collaboration with our partner organizations in USA (AAPS), China (CBF) and Japan (JBF).

On Sunday evening, we welcome all delegates for a complementary cocktail reception. On 20 and 21 May, we will discuss the details of the draft guideline, suggest enhancements and/or clarifications during presentations, Q&As and panel discussions. On 22 May, we discuss and agree on the conclusions from the workshop. The outcome of the meeting will be considered for submission to the ICH and, if desired, can be the basis or an addition for comments by individual organisations.

 

WHO SHOULD ATTEND?

Scientists and managers from Pharma R&D, CRO and Health Authorities involved in BMV & sample analysis. We also like to invite the stakeholders and end-users of the bioanalytical data to gauge their view and expectations of the new ICH M10 Guideline.

The draft agenda of the meeting will become available on the meeting website in the coming weeks (final agenda anticipated around end of March)