Regulatory Project Director Lars Hyveled-Nielsen, Zealand Pharma IFF Meeting RA Network Drug-device combinations regulated as medicines - Revised regulatory framework with implementation of the new Medical Device Regulation from 26 May 2020 Regulatory Project Director Lars Hyveled-Nielsen, Zealand Pharma Symbion 28 January 2019 Chair: Ulla Schmit Haagen, LEO Pharma

Agenda Monday 28 January 16:30-18:30 Wellcome to the RA Network, Ulla Schmit Haagen, LEO Pharma Presentation round – All Drug-Device Combinations Regulated as Medicines - Revised Regulatory Framework with introduction of the new Medical Device Regulation from May 2020, Regulatory Project Director Lars Hyveled- Nielsen, Zealand Pharma Break Discussion of regulatory impact Goodbye/Sandwichs

Planned meetings 2019 7 Jan 2019: Fixed Dose Combination, CORS PhD Student Asbjørn Nøhr-Nielsen, Copenhagen Centre for Regulatory Science 28 Jan 2019: Drug-Device Combinations Regulated as Medicines - Revised Regulatory Framework with introduction of the new Medical Device Regulation from May 2020, Regulatory Project Director Lars Hyveled- Nielsen, Zealand Pharma 28 March 2019: Brexit and EMA relocation, Director of Europe for Global Regulatory & Science Policy Pedro Franco, Merck KGaA London, Regulatory Intelligence Specialist Dorte Björn Larsen, Novo Nordisk A/S, NN, LEO Pharma 21 May 2019: ICH Guideline E17 Multi-Regional Clinical Trials, Manager RA Intelligence Vibeke Bjerregaard TBD 26 Aug/9 Sep 2019: China Regulatory Environment, Intelligence Manager Anette Hjelmsmark, Novo Nordisk  

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Back up slide TOPRA London TOPRA Sweden (Margaret Jorvid) Collaboration established – 1 yearly meeting event in Denmark together with TOPRA London We share our plans with TOPRA London TOPRA Sweden (Margaret Jorvid) CORS positive about collaboration (Merete Schmiegelow represents)