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TIDES Europe: Oligonucleotide and Peptide Therapeutics

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Delivered as Hybrid Event from 16-18 November 2022
Live In-Person Conference Delivered 16-18 NovemberAustria Center Vienna

Christian Wetter, PhD
Portfolio Leader, Pharma Technical Regulatory at Roche

Profile

Christian is a chemist by training. He completed his studies at ETH Zurich and his PhD at University of Marburg.

He started his career in industry in chemical development at Roche in 2004. In 2009 he moved to Regulatory CMC at Novartis where he worked in roles with increasing responsibilities. In 2020 Christian moved back to Roche and currently acts as a Portfolio Leader in technical regulatory.

In his current role Christian’s focus lies on oligonucleotide development, new technologies development, device development, as well as nitrosamines/mutagenic impurities. In the oligonucleotide field he leads the regulatory subteam in the European Pharma Oligoncleotide Consortium (EPOC).This group works on gaining regulatory acceptance for solution APIs.

Today’s talk will provide insights on benefits of using solution APIs, faced regulatory challenges, and proposed paths forward.

Agenda Sessions

  • Solution Oligonucleotide APIs: Regulatory Considerations

    09:45