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In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. This guideline will provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins. The guideline was first published in March 14, 2019 and consultation technically ends September 1, 2019. Please refer to https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation. The purpose of this meeting is to update the local bioanalytical and PK community on the latest commentary on this guideline from experts fresh from meetings sponsored by the FDA, AAPS and the EBF.

8:30 – 9:30 am

Registration

9:30 – 10:00 am

Welcome and Introduction
Mark Arnold (Covance)

10:00 – 10:45 am

EBF Small Molecule View
Philip Timmerman (EBF)

10:45 – 11:00 am

Coffee Break

11:00 – 11:45 am

EBF large molecule view
Jo Goodman (MedImmune)

11:45 – 12:00 pm

Q & A

12:00 – 1:15 pm

Lunch

1:15 – 2:00 pm

AAPS small molecule view
Steve Lowes (Q2 Lab Solutions)

2:00 – 2:45 pm

AAPS large molecule view
Boris Gorovits (Pfizer)

2:45 – 3:00 pm

Coffee Break

3:00 – 4:00 pm

Roundtable