1. 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

2. 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

3. 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

4. Thank you for joining!

5. 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)