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Gert Thurau, PhD
Head of Manufacturing Technology Innovation in CMC Reg Policy
Roche
Dr. Gert Thurau is the Lead of Advocacy for Manufacturing Technology and Innovation 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.
With a focus on the use of AI and ML in Manufacturing, he is participant in multiple industry associations teams on AI, such as leading the EFPIA Manufacturing Quality Expert Group topic team “Process Modeling”, the IFPMA Quality Manufacturing Working group Advanced Manufacturing team, the ISPE Community of Practice AI regulatory subcommittee co-lead and in BIO and PhRMA. He also participated for Roche in the EMA Quality Innovation Group “Listen and Learn” session on “AI in Manufacturing” in 2023 and 2024 and is a frequent speaker and session host at relevant regulatory conferences such as DIA, CASSS CMC, ISPE and the PIC/S inspectors seminar topic “AI in Manufacturing” in Hongkong in 2025.
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