Kowid Ho

F. Hoffmann-La Roche Ltd.

Kowid Ho is working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland, where he performs senior strategic review on projects and advises on Roche global positions for Biologics.

Kowid has over 20 years of experience in the regulatory affairs of biotech products (Quality aspects), including 13 years at ANSM (Agence nationale de sécurité du médicament et des produits santé). He has been a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT team. He participated in the drafting of several European guidelines (e.g., EMA process validation, biosimilar, Monoclonal antibody, EDQM HCP and rDNA) as well as international guidances (e.g., ICH Q11, WHO guideline for biotherapeutic protein). He is currently involved in ICH Q12, EFPIA MQEG ATMP team, and IFPMA ATG