Dr. Petra Heyen

I provide Regulatory, PV and Quality advice particularly to start-up companies and small biotech companies with focus on European market entry during the drug development and submission/approval process.

1/ enterprise-wide responsibility for scientific evaluation of projects / products / companies ready for acquisition as (due diligence) 2/ Global Regulatory Lead for a company compound 3/ Regional European Regulatory responsible for all company compounds 4/ Manages the European Regulatory Affairs with different service providers Provides RA support to all European country organisations 5/ Provides functional support to all Regulatory Affairs associates via a dedicated functional forum

Insert a matrix organisation. Scientific part of due diligence, integration into the Therabel organisation after acquisition and regulatory EU approval(s). Project responsibility for all Therabel internal projects (mainly life cycle management). Oversee all activities for quality, project management, CMC, manufacturer interactions, partner companies. Design, implement, maintain a Euopean PharmacoVigilance System for Therabel. EU-QPPV, national QPPV in some affiliates. Oversee all clinical trials of Therabel

European Health Economy Systems