Gert Thurau
F. Hoffman-La Roche AG
CMC Reg Policy Manufacturing Innovation
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering the spectrum from continuous processing, use of process models, robotics and artificial intelligence, to name a few.
Over the last 20 years, he has been involved in many key initiatives and regulatory interactions in the field of technology innovation, Quality by Design, including Real-Time Release Applications, advanced control systems but also the implementation of ICH Q12. Previous responsibilities at Roche include the lead of the synthetic molecule Reg CMC team with 2 successful submissions to the FDA and Health Canada Pilot Program on Established Conditions. Within the greater community, he has been chairing conference sessions on QbD incl. ICH Q12 and technology innovation in manufacturing throughout his career.
Over the last 20 years, he has been involved in many key initiatives and regulatory interactions in the field of technology innovation, Quality by Design, including Real-Time Release Applications, advanced control systems but also the implementation of ICH Q12. Previous responsibilities at Roche include the lead of the synthetic molecule Reg CMC team with 2 successful submissions to the FDA and Health Canada Pilot Program on Established Conditions. Within the greater community, he has been chairing conference sessions on QbD incl. ICH Q12 and technology innovation in manufacturing throughout his career.