Wassim Nashabeh

F. Hoffmann-La Roche Ltd.

Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific organizations. Wassim is a member of the ICH Management Committee (formerly known as Steering Committee) and Assembly and has been a member of several ICH Expert Groups including Q3D, Q11 and Q12 on behalf of BIO. Wassim is a CASSS Fellow and the chair of the CASSS CMC Forum Global Advisory Board that oversees the CMC Forum meetings in US, EU, Japan and LATAM. Wassim is also a member of several advisory boards including the APEC Regulatory Harmonization Steering Committee and Harmonization Centre, a Visiting Expert at Duke-National University of Singapore Medical University Centre of Regulatory Excellence. Wassim has a Ph.D. in analytical chemistry and a post-doctoral fellowship in Bio analytical, and is the author of over 30 scientific publications, reviews and patents in the fields of separation science and biotechnology.

Dr. Hiroshi Suzuki is currently Director of Center for Product Evaluation & Director of Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency. He was previously a professor of Department of Pharmacy, The University of Tokyo Hospital, at The University of Tokyo. He received Ph.D. in Biopharmacy from The University of Tokyo in 1989.