Programme

Swissmedic information event

"Regulatory&Beyond"

20 September 2022, Hotel Allegro/Kursaal Bern, 9.00 a.m. to 5.30 p.m.

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:

  • Raimund Bruhin, Executive Director, Swissmedic
  • Claus Bolte, Head of Authorisation Sector
  • Philippe Girard, Head of Licensing Sector
  • Helga Horisberger, Head of Legal Affairs Sector
  • Daniel Leuenberger, Head of Infrastructure Sector
  • Karoline Mathys, Head of Market Surveillance Sector
  • Jörg Schläpfer, Head of Management Services & International Affairs Sector
  • Barbara Schütz, Head of Human Resources and Finance Sector

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

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

  • What does centre of expertise for ATMPs mean? Why is such a centre needed?
  • Tasks and goals of the centre of expertise for ATMPs
  • Developments in the field of ATMPs as a challenge
  • The regulatory response to ATMP innovations – The role of Swissmedic

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

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

  • Fast-track evaluation of Phase 1 studies
  • DCTs

Alex Mion

2.15–3.00 p.m.

Digitalisation: Opportunity, challenge and limits

  • Paperless establishment licences from submission to issuance: Utopia or imminent reality?
  • Remote assessment instead of on-site inspections: Conceivable? Desirable? Feasible?

Federico Cimini

Georges Meseguer

Christian Schärer

3.00–3.20 p.m.

Remote approaches to GCP and GVP regulatory oversight

  • Remote GCP/GVP inspections, opportunities and challenges
  • Desk-based inspections

Simone Ferbitz

3.20–3.40 p.m.

Changes in narcotics legislation concerning the medical use of cannabis

  • What is now possible?
  • Cultivation of cannabis for medical use

Monika Joos

4.00–5.30 p.m.

Swissmedic Info Market incl. drinks reception

 

Session: Authorisation and life cycle management

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

  • Review/outlook: Access
  • Review/outlook: Orbis

Cornelia Bigler

Ulrich Rohr

2.20–2.40 p.m.

Temporary additional indications

Anna Barbara Stalder

2.40–3.00 p.m.

Nanosimilars / 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

(number of reports, SwissPAR, EPAR in the public eye)

Christoph Küng

4.00–5.30 p.m.

Swissmedic Info Market incl. drinks reception

 

Session: Veterinary medicinal products

Presentations in German without simultaneous interpreting

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

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

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 17.06.2022

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