Towards harmonised implementation of the ICH M10 Guideline

When: On November 15th (= the day preceding the 15th Open Symposium)

The agenda planning has started. The aim of the meeting is to provide the industry all tools for a diligent and harmonised implementation of the new ICH M10 Guideline. We will invite regulators around the globe to join us as panellists, because harmonised implementation builds on harmonised interpretation by industry and regulators together.

Our current thinking is to divide the day into (plenary and breakout) sessions each focusing on a different chapter of the ICH M10 Guideline. In each session, we will start with a “What’s New?” presentation given by a EBF experts, followed by a panel discussion/Q&A on pre-submitted questions (submitted by delegates), questions generated by the EBF community (as part of the day-to-day EBF interactions) and live questions from the delegates will bring to the meeting.

A draft agenda layout can be found here

As ever, it is our intention to closely collaborate with other regional organisations representing the bioanalytical community in their region (e.g. AAPS, JBF or CBF).

The ICH M10 meeting is planned as a stand alone and non-sponsored meeting. A separate registration required. No combo-registration, vouchers or other discounts are applicable.