Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance.

Klaudija is a physician with more than 20 years of experience in different pharmacovigilance fields. At present, she is Head of TPC – unit responsible for Company Core Safety Information, aggregate reports and risk management worldwide, supporting marketing authorizations and safety strategy for generics, biosimilar and innovative Teva products. Klaudija led in-house development of additional risk minimisation (ARM) implementation tracking tool and ARM digitalisation. Klaudija is Co-Chair of the Pharmacovigilance Working Group in Medicines for Europe.