Gert Thurau

Background

About Gert Thurau

Accomplished pharmaceutical professional with 24 years of international experience and proven success as a leader in drug technical development, product registration and manufacturing. In the current role as the lead of CMC Reg Policy for Advanced Manufacturing and Technology Innovation I am combining my career experiences and leadership in manufacturing technology innovation as well as CMC registration. Particular focus is on the use of Artificial Intelligence and Machine Learning in regulated applications in pharmaceutical manufacturing, within the spectrum of GMP-to-dossier relevance. Representing on the topic of AI and ML in manufacturing in international industry associations such as BIO, EFPIA, IFPMA. Other topic areas include Process Modeling, DM and POC Manufacturing, RTRT Applications, Continuous Manufacturing. Skilled negotiator in face-to-face meetings with global health authorities, recognized within the industry for leadership in Quality by Design (QbD), ICH Q12 guideline and innovative manufacturing technology emerging regulation. Multiple interactions with the FDA Emerging Technology Program, EMA Quality Innovation Group, Swissmedic Scientific Advice on manufacturing innovation. Past accomplishments include product registrations with significant QbD elements, Real-Time Release Testing (RTRT), PAT methods registration. Experienced people leader incl. manager of managers with local management experience in several countries (Switzerland, USA, Canada, Ireland). Expertise- Advanced manufacturing, AI & ML, RTRT, DM and POC Manufacturing, Robotics - CMC clinical trial registration, regulatory strategy for accelerated drug development (Break-through, PRIME, Sakigake)- Life Cycle management of registrations including ICH Q12. Strategy development for Process Analytical Technology (PAT) and Quality by Design (QbD)