Conference Room “Arena”
Time |
Topic |
Speaker |
---|---|---|
From 8.30 a.m. |
Welcome coffee and registration |
|
9.00 a.m. |
Introduction & welcome |
Eliane Schmid |
9.05–9.15 a.m. |
Executive Director's welcome |
Raimund Bruhin |
9.15–10.10 a.m. |
Swissmedic – fit for the future Podium discussion with the Management Board:
|
Moderated by Eliane Schmid |
10.10–10.30 a.m. |
Innovation@Swissmedic How innovative can a regulatory agency be? – Opportunities, limits & approaches |
Philippe Girard |
10.30–10.55 a.m. |
Swissmedic 4.0: Digitalisation in concrete terms |
Michael Renaudin |
10.55–11.00 a.m. |
Organisational information |
Eliane Schmid |
11.00–11.25 a.m. |
Short coffee break |
|
& Beyond: Parallel session: Medicinal products – Life cycle and special topics
Conference Room “Arena”
Time |
Topic |
Speaker |
---|---|---|
11.30–11.35 a.m. |
Welcome and presentation of the programme |
Claus Bolte |
11.35–11.55 a.m. |
Real world evidence |
Lorenzo Hess Leonie Rudofsky |
11.55 a.m.–12.10 p.m. |
Centre of expertise for ATMPs
|
Julia Djonova |
12.10–12.30 p.m. |
Market surveillance of medicinal products: Genotoxic impurities – What Swissmedic expects |
Susanne Wegenast Thomas Hottiger |
12.30–1.45 p.m. |
Lunch break with buffet lunch & Swissmedic Info Market |
|
Session: Clinical trials and licensing
Conference Room “Aare”
Time |
Topic |
Speaker |
---|---|---|
1.45–1.50 p.m. |
Welcome and presentation of the programme |
|
1.50–2.15 p.m. |
Focus on innovation: Early phase clinical trials and DCTs
|
Alex Mion |
2.15–3.00 p.m. |
Digitalisation: Opportunity, challenge and limits
|
Federico Cimini Georges Meseguer Christian Schärer |
3.00–3.20 p.m. |
Remote approaches to GCP and GVP regulatory oversight
|
Simone Ferbitz |
3.20–3.40 p.m. |
Changes in narcotics legislation concerning the medical use of cannabis
|
Monika Joos |
4.00–5.30 p.m. |
Swissmedic Info Market incl. drinks reception |
|
Session: Authorisation and life cycle management
Conference Room “Arena”
Time |
Topic |
Speaker |
---|---|---|
1.45–1.50 p.m. |
Welcome and presentation of the programme |
Simon Dalla Torre |
1.50–2.20 p.m. |
International cooperation
|
Cornelia Bigler Ulrich Rohr |
2.20–2.40 p.m. |
Temporary additional indications |
Anna Barbara Stalder |
2.40–3.00 p.m. |
Non-biological complex drugs (NBCDs) |
Matthias Gautschi |
3.00–3.20 p.m. |
Experience with applications per Art. 14 para. 1 let. abis-quater TPA |
Martina Gerber |
3.20–3.40 p.m. |
Experience with patient reports during the COVID pandemic in Switzerland |
Thomas Stammschulte |
3.40–4.00 p.m. |
Limits of transparency illustrated by COVID-19 | Christoph Küng |
4.00–5.30 p.m. |
Swissmedic Info Market incl. drinks reception |
|
Session: Veterinary medicinal products
Presentations in German without simultaneous interpreting
Conference Room “Panorama 4”
Time |
Topic |
Speaker |
---|---|---|
1.45–2.00 p.m. |
Welcome |
Nina Walser |
2.00–3.00 p.m. |
Transfer of immunological veterinary medicinal products from IVI to Swissmedic |
Rosa Stebler-Frauchiger Barbara Wieland (IVI) Nina Walser |
3.00–3.30 p.m. |
Revised VMP legislation |
Peter Schmid Stefan Herrli |
3.30–4.00 p.m. |
International collaboration |
Catharina Lany |
4.00–5.30 p.m. |
Swissmedic Info Market incl. drinks reception |
|
Session: Complementary and herbal medicines
Presentations in German without simultaneous interpreting
Conference Room “Panorama 1”
Time |
Topic |
Speaker |
---|---|---|
1.45–2.00 p.m. |
Welcome |
Martin Ziak Bilkis Heneka |
2.00–2.20 p.m. |
Presenting our new complementary and herbal medicines website! |
Christine Ruppen Michaela Stach-Rüefli |
2.20–2.40 p.m. |
Simplified authorisation procedure for herbal medicines according to Art. 14 para. 1 let. cbis and abis-quater TPA |
Anne-Isabelle Reich Tobias Schlechtinger |
2.40–3.00 p.m. |
Complementary medicines: Requirements for bibliographical evidence in connection with simplified authorisation procedures |
Julie Morciano |
3.00–3.10 p.m. |
Medicinal products and procedures authorised in foreign countries for CHM (Art. 13 TPA) |
Julian Affolter |
3.10–3.30 p.m. |
Notification procedure for homeopathics/anthroposophics – efficient submissions |
Conwitha Lapke |
3.30–4.00 p.m. |
Q&A session |
All |
4.00–5.30 p.m. |
Swissmedic Info Market (without CHM stand) incl. drinks reception |
|
& Beyond: Parallel session: Medical devices – Life cycle of and special topics
Conference Room “Szenario 1 & 2“
Time |
Topic |
Speaker |
---|---|---|
11.30–11.35 a.m. |
Welcome and presentation of the programme |
Karoline Mathys |
11.35 a.m.–12.15 p.m. |
Global Regulatory Requirement for medical devices Presentation in English |
Michael King Senior Director, Product & Strategy, IQVIA |
12.30–1.45 p.m. |
Lunch break with buffet lunch & Swissmedic Market |
|
1.45–2.15 p.m. |
Cyber security and medical devices Presentation in French |
Solange Ghernaouti Professor, Director of the Swiss Cybersecurity Advisory & Research Group, University of Lausanne |
2.15–2.45 p.m. |
Clinical data – Challenges since the introduction of the MDR |
tbd |
2.45–3.15 p.m. |
Transparency and medical devices – Implementation in the EU and Switzerland Presentation in English |
Richard Houlihan CEO, EirMed (@ eudamed.com) |
3.15–3.45 p.m. |
Artificial intelligence in medical devices Presentation in German |
André Baumgart Advisor Medical AI Products / Lead Scientist AI-based Health Systems |
4.00–5.30 p.m. |
Swissmedic Info Market incl. drinks reception |
|
Last modification 08.09.2022