M10 AGENDA

When: On November 14th (= the day preceding the 16th Open Symposium)

After careful consideration, we again plan for a non-sponsored pre-symposium workshop on ICH M10. In contrast to last year, where we tried to prepare for a harmonised interpretation and implementation of the recently published guideline, the set up of this meeting will be different: sharing experience and discussing/removing ambiguities
With one year into ICH M10, we already observe that industry is ambiguous or interprets/implements the guideline differently, requiring us to come together. We feel that including the ICH M10 discussion into the 16th OS program would compromise the other items of the agenda and your and our goal of the 16th OS. Hence, a separate workshop.
For the workshop, we plan to discuss case studies and experience with the guideline, how you updated your processes or SOPs and/or (re-)validated your assays. We hope to share and discuss multiple (and different) views on how you implemented one or the other requirement, including the first experience during filing and review by HA.

We are sensitive that we add another day in your busy schedule, but it will be well spent! Not investing the time early in the process of ICH M10 implementation will inevitably lead to divergence of how we read and implement ICH M10, with resources and time waisted.

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).

For abstract submission (focus on case studies and experience), go to tab M10 ABSTRACTS

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.