Congress Program
08:00
Registration
08:50
Conference Opening & Welcome
Bassil Akra, Conference Chair
09:00
Session 1: General Requirements and Classification
09:00 - 09:30
MDR Implementation and Legal Requirements
Glenda Marsh
Senior Director, EMEA Regulatory Affairs, Johnson & Johnson, Switzerland
09:30 - 10:00
Changes in the Classification System
Elizabeth Gfoeller
Corporate Director Regulatory Affairs, MED-EL, Austria
10:00 - 10:30
Strategic Considerations for the Conformity Assessment
Bassil Akra
Founder and CEO Akra Team, Germany
10:30
Coffee Break, Networking and Visit the Exhibition
11:00
Workshop 1
- Workshop in different break-out groups, led by the presenters of Session 1 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Tasks will be identical for each group but with different examples
- Group will ‘develop’ one device including classification and regulatory strategy
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
12:30
Lunch Break, Networking and Visit the Exhibition
13:30
Session 2 – Conformity Assessment Plan
13:30 - 14:00
Labeling Changes under the MDR
Daniel Rubisoier
Regulatory Affairs Specialist, TÜV SÜD, Austria
14:00 - 14:30
Content of the Technical Documentation
Morwan Choli
Executive Vice President R&Q, Occlutech, Japan
14:30 - 14:45
EUDAMED Update (
Pre-Recorded)
Pre-Recorded)
Richard Houlihan
CEO, EirMed, Belgium
14:45 - 15:00
UDI Requirements
Daniel Rubisoier
Regulatory Affairs Specialist, TÜV SÜD, Austria
15:00
Coffee Break, Networking and Visit the Exhibition
15:30
Workshop 2
- Workshop in different break-out groups, led by the presenters of Session 2 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Participants will develop a draft IFU and draft TD structure for their developed device
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
17:00
End of Day One
08:30
Registration
09:00
Session 3: Clinical Evaluation
09:00 - 09:30
Planning of the Clinical Evaluation Including Clinical Strategies
Rachel Mead
Clinical Regulatory Lead, BSI Group, UK
09:30 - 10:00
Relevant Aspects of a Scientifically Valid Literature Search
Shelley Jambresic
Senior Clinical Evaluation Manager, Geistlich Pharma, Switzerland
10:00 - 10:30
Medical Device Software and Cybersecurity
Eric Vollebregt
Partner, Axon Lawyers, Netherlands
10:30
Coffee Break, Networking and Visit the Exhibition
11:00
Workshop 3
- Workshop in different break-out groups, led by the presenters of Session 3 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Based on the example device and the draft CEP they would decide on the clinical strategy
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
12:30
Lunch Break, Networking and Visit the Exhibition
13:30
Session 4: Post-Market Requirements
13:30 - 14:00
PMS and Vigilance Requirements
Danielle Giroud
Founder and CEO, MD Clinicals, Switzerland
14:00 - 14:30
General and Specific PMCF Activities
Matthias Fink
Senior Clinical Consultant, Akra Team, Germany
14:30 - 15:00
PSUR and SSCP
Christoph Ziskoven
Clinical Expert Medical Devices, TÜV Rheinland, Germany
15:00
Coffee Break, Networking and Visit the Exhibition
15:30
Workshop 4
- Workshop in different break-out groups, led by the presenters of Session 4 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Groups would develop draft PMCF Plan, PSUR and SSCP for their example devices
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
17:00
Conference Closing
