National Regulatory Conference
Everything you need to know about present and future regulations
The National Regulatory Conference will shed a light on all regulatory aspects that will affect the medtech industry today and in the near future. Aside from the ongoing matters around MDR/IVDR and the Swiss MdeDO/IvDO, it will also deal with the use of health data and the reporting of sustainability topics.
A plenary session will show in a concise overview what everybody needs to know about medical device regulation, health data, sustainability and corporate governance. Following that, plenty of time is reserved for breakout sessions where the individual topics will be addressed in depth.
Secure your ticket now, as the attendance is limited to 500 participants. The event language is English.
National Regulatory Conference
18 October 2023
BERNEXPO Congress 1.3
Mingerstrasse 6, 3014 Bern
Website
Programme
Morning
Dr Beat Vonlanthen, President Swiss Medtech
Moderated by Dr Daniel Delfosse, Head of Regulation & Innovation Swiss Medtech
- Who benefits from the patient data? Opportunities and risks of digitization from the perspective of those affected
Susanne Gedamke, SPO Swiss Patient Organisation - Handling of health data: what everyone needs to know
Dominik Geller, Hygiaso - Non-financial reporting and supply chain management: what everyone needs to know
Simon Heller, Deloitte - Status of acceptance of FDA approved products for Switzerland
Sandra Rickenbacher-Läuchli, Head of Public Affairs & Legal Counsel Swiss Medtech - Round table «Third country to the EU: How the UK is shaping its medical device regulation»
Phil Brown, Director Regulatory & Compliance, Association of British Health Tech Industries ABHI with Dr Daniel Delfosse
Afternoon
- Who benefits from the patient data? Opportunities and risks of digitization from the perspective of those affected
- Genom meets iPhone – Health data and data democracy
Prof. Ernst Hafen (Swiss Health Data Space) - Smart segregation of Medical Device Software (MDSW)
Christoph Anderegg (ISS AG, Integrated Scientific Services) - Funding opportunities in Europe? Yes, more than you think!
Sasha Hugentobler (Euresearch) - Outlook & Farewell
Breakout Sessions
Morning
Breakout Session 1
MDR/IVDR
11.15 – 12.30
Pain points for Swiss economic operators
moderated by Markus Wipf (Axxos)
Talks
- How to prepare for Swissmedic inspections of manufacturers, CH-REPs and importers
Dr Sebastian Fuchs (Swissmedic) - Pitfalls for importers and distributors
Angelina Hakim (Qunique) - 5000 articles from 200 manufacturers – Case report of the MedDO implementation at a large Swiss distributor
Janik Weigele (Gribi Belp)
Breakout Session 2
Health Data
11.15 – 12.30 h
The European health data space – Impact on Switzerland
moderated by Jasminka Roth (The Tao of Excellence)
Talks
- EU data laws affecting the MedTech industry and implementation in Switzerland
Eva von Mühlenen (Sidley) - MedTech Europe Position on EHDS (European Health Data Space)
Verena Thaler (MedTech Europe) - Preparing the Health Data Foundation in Switzerland
Rajesh Nair (Swiss Post)
Breakout Session 3
Sustainability
11.15 – 12.30 h
The European & Swiss framework for sustainability and reporting of ESG
moderated by Dr Holger Hoffmann-Riem (Go for Impact)
Talks
- The impact of the EU laws on medtech companies (The green deal)
Jesus Rueda Rodriguez (MedTech Europe) - What is requested from you? How to deal with the EU laws – no overkill
Simon Heller (Deloitte) - Crossroads of EU and Swiss reporting initiatives for Swiss based companies
Johann Weicht (ERM)
Afternoon
Breakout Session 4
MDR/IVDR
13.45 – 15.00 h
How to bring innovations on the market in Europe
moderated by Frederike Brühschwein-Mandic (Confinis), Michael Maier (Medidee)
Talks
- First experience with (technical documentation of) AI under the MDR: what is needed
Prof Dr Stephen Gilbert (Else Kröner Fresenius Center for Digital Health) - Handling of conformity assessment requests for Medical Device innovations by TÜV Süd
Alberto Mangone (TÜV Süd Italy) - How to get clinical data for innovative products
Rainer Voelksen (Cairdac)
Breakout Session 5
Health Data
13.45 – 15.00 h
Electronic health data in Switzerland
moderated by Bernhard Bichsel (ISS AG)
Talks
- Navigating the future of healthcare: Exploring DigiSanté's role in healthcare transformation
Matthias Becher (BAG, Federal Office of Public Health) - Eye to eye with AI: Opportunities and pitfalls
Prof Raphael Sznitman (CAIM, University of Bern) - Health data's edge – Insights in a data-rich era
Jasminka Roth (The Tao of Excellence)
Breakout Session 6
Sustainability
13.45 – 15.00 h
The carbon footprint of the Swiss medtech industry
moderated by Barbara Mettler (Swiss Medtech)
Talks
- Practical implications of the new Swiss requirements on climate-related disclosures
Jonathan Schwieger (First Climate) - Ambitious journey to net-zero: challenges and promising approaches of a manufacturing company
Sabine Huber (Ypsomed) - Tackling carbon accounting and the roadmap to Net-Zero
Raïna Rasper (Cendres+Métaux)
Speakers
Pricing
The following elements are included in the ticket price:
- Conference ticket incl. refreshments
- Access to list of participants and presentation documents
- Certificate of attendance
CHF 430 – Standard ticket
CHF 290 – Reduced ticket
The following participants are granted a 33% discount on the standard rate:
- Swiss Medtech members
- SVDI/ASID members
- SwAPP members
- ASD members
- Representatives of public authorities / politics
- Start-ups
Venue
The event will be held at BERNEXPO Congress 1.3.
Information on how to get there and access to parking can be found here.
Area under construction
The expo area is currently undergoing major cunstruction. Therefore, the access route has changed slightly, see detailed plan below.
We recommend to exit Tram no. 9 at the stop "Wankdorf Center" and following the signs from there for easiest access to Congress 1.3.
