Harry Berlanga

Senior Director, Quality, EMEA,
Thermo Fisher Scientific

Alessandro Barbato, PhD

Qualified Person for drug substance
and steriles, Thermo Fisher Scientific

Qualified persons (QPs) play an essential role in the European clinical trial supply chain.

To help drug sponsors understand and overcome the regulatory hurdles and expedite time to clinic, this paper provides critical direction and support for the following activities:

• Maximizing the chances for seamless and effective interactions with QPs
• Anticipating QP requirements
• Understanding the impact of Brexit on QP processes
• Navigating the QP landscape to facilitate timely and efficient batch release of commercial and clinical drug product supply