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RSNN annual workshop 2021

Van Derden


The Regulatory Science Network Netherlands (RSNN) will organize its annual workshop this year on Tuesday 23 November (Jaarbeurs, Utrecht, The Netherlands). This meeting will focus on the ‘upstream’ coordinated, structured and harmonized regulatory framework established at a European level (high level of convergence) transferring ‘downstream’ to individual member states with each their own interpretations (lower level of convergence).

In this RSNN workshop we want to explore if and how these differences in downstream interpretation between nations affect accessibility of medicines and treatments for patients. Are the existing differences undesirable and/or inevitable? What is the view of the stakeholders involved (regulator, academia, industry, and patients) regarding international differences in interpretation of upstream harmonised systems? Specific present day regulatory topics will be presented to elaborate upon this topic, including (inter)national differences in vaccination strategies, ATMP treatment under the Hospital Exemption, and health technology assessment.

Registration is now open

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13:30Registration and coffee
14:00Welcome – Sjaak Bot (Janssen)
14:05Opening & Problem analysis – Sabine Straus (MEB, PRAC)
14:15COVID-19 vaccination strategies – Hans Schikan (Special Envoy vaccines Netherlands, VWS)
14:30ATMP-treatment under the Hospital Exemption – Delphi Coppens (KWF)
14:45Health Technology Assessment – Wim Goettsch (UU)
15:00The perspective of the patient on upstream convergence and downstream divergence – Wim Altena & Carine Besselink (EUPATI)
15:15The perspective of the regulator on upstream convergence and downstream divergence – Anthony Humphreys (EMA)
16:10Upstream convergence and downstream divergence in other domains – Bernard Steunenberg (LUMC)
16:35Plenary discussion  – Chaired by Marjon Pasmooij (MEB)
Panellist 1: Sini Eskola (EFPIA)
Panellist 2: Anthony Humphreys (EMA)
Panellist 3: Sabine Straus (MEB, PRAC)
Panellist 4: Bert Leufkens (Lygature)
Panellist 5: Larissa de Lannoy (PSC Patients Europe)
Panellist 6: Hans Schikan (Special Envoy vaccines Netherlands, VWS)
17:20Closing – Sjaak Bot (Janssen)
17:30Drinks & Networking