ICH M4Q(R2): Advancing the Common Technical Document for the Registration

ACPA 2024 Webinar 4: ICH M4Q(R2): Advancing the Common Technical Document for the Registration of Pharmaceuticals

Speaker: Lawrence X. Yu, Ph.D.

When: Nov 16, 2024 20:00-21:30 EST

About the Speaker: Lawrence X. Yu, Ph.D., is the Director of the Office of Product Quality Assessment ll at FDAand the Rapporteur of the ICH M4Q(R2) Expert Working Group. He also serves as an adjunctprofessor at the University of Michigan and as an Associate Editor of the AAPs Journa. Heplayed a pioneering role in introducing QbD into the pharmaceutical field and originated theKASA initiative to enhance knowledge management and facilitate digitalization. Currently,Dr. Yu is spearheading an lCH Expert Working Group to transform the M4Q(R1) guideline toimprove the registration and lifecycle management, He has authored or co-authored over 150 scientific papers and delivered more than 400 invited presentations.

Host or Publisher American Chinese Pharmaceutical Association