Programmes

See below for the most up-to-date programme details for the TOPRA Annual Symposium.

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Medical Devices / IVDs Symposium 2022

18 October

 

  All times CEST (GMT+2)
 

10:30 – 11:00

Registration Medical Devices/IVDs Symposium
  11:00– 11:45

TOPRA Annual Lecture

  11:45 – 12:30

TOPRA Annual Review Meeting 

  12:30 –  13:30 Lunch Break
  13:30 –  14:00 Welcome to the Medical Devices/IVDs Symposium – key note speaker
  14:00 – 15:30

HM5MD1: Digital health opportunities and advancements in healthcare

Lead:

  • Bjorg Hunter - Department Affairs Director, Regulatory Affairs Digital Health, Novo Nordisk, Denmark

The advancements in Digital Health are on a steep increase, further fuelled by the restrictions of COVID-19. During the lockdown period it became even more apparent how digital solutions can be a significant help for both patients and HCPs in managing disease. Digital Heath can also be many things: from simple log book apps and health monitoring devices to complex algorithms and Artificial Intelligence (AI) capable of providing insight and recommendations to care. As digital tools become more and more advanced so will the regulatory landscape around it. Of course, patient safety is always at the core and because of this we have to collectively find ways that ensure patient safety while also encouraging innovation. Organisations around the world including WHO, EMA and FDA, have therefore developed a Digital Health strategy and so will most pharmaceutical and Medical Device companies. This session will explore the complexity of regulating Digital Health in an ever evolving world.

Speakers:

  • Vikas Jaitely - Head Digital Health and Devices, Merck, Switzerland
  • Søren Smed Østergaard - Vice President Digital Health, Novo Nordisk, Denmark
  • Thorsten Vetter - Scientfic Administrator, European Medicines Agency (EMA)

Panellist:

  • Georg Neuwirther - Head of IT, Austrian Medicines and Medical Devices Agency (AGES), Austria
 
 

15:30 – 16:00

Networking Break
  16:00 – 17:30

MD2: How to approach Artificial Intelligence and Cybersecurity now and in the future

Lead:

  • Martin Witte - Global Director Focus Team, Active Implantable & Cardiovascular Devices, TÜV SÜD Product Service, Germany

Artificial intelligence and cybersecurity are two hot topics in the medical device sector. However, there are also a lot of uncertainties around these two topics, in this session an insight to the latest developments on Artificial Intelligence will be provided, showing the complexity of the law-making process currently ongoing on EU level.

Notified bodies are obliged to assess artificial intelligence and cybersecurity topics already now within their assessment, of importance interest here is the level of evidence that can be provided to show compliance to the MDR requirements.

Another key part of the process is actively developing and creating the current state of the art around requirements which shall be applied for AI & cybersecurity assessments.

Speaker:

  • Jan Kuefner - Senior Product Specialist for Cybersecurity of Medical Devices, TUV SUD, Germany
  • Michelle Jump - Vice President Security Services, MedSec, USA
  • Koen Cobbaert - Senior Manager - Quality, Standards & Regulations. Philips, Belgium

 

19 October

 

  All times CEST (GMT+2)
    Welcome to Day 2

    Delegates have the option to follow an MD stream or an IVD stream for the next two sessions.

 

  9:00 – 10:30

MD3: Clinical investigation from a virtual setting perspective

Lead:

  • Alwin van den Broek - Project Manager and Data Protection Officer, Avania Clinical, the Netherlands

Over the past couple of years digitalization has entered the industry, probably faster and sooner than many of us anticipated. This development has definitely impacted many processes in the industry and medical devices are surely not an exempt to this. With the implementation of the MDR, Med-Tech companies have more than ever embraced the importance of data generation and data collection. Therefore, it is not surprising that already within the design of medical devices more and more digital communication tools are implemented. During this session the attendee will learn the current environment and the complexities surrounding digital features of medical devices, while also looking at the security challenges and possible solutions that would help overcome them. This session will be concluded with a discussion and the outlook on the future from the expert panel.

Speakers:

  • Jón Ingi Bergsteinsson -  Founder & Director of EMEA Sales, Smart Trial, Denmark
  • Conor Hogan - Senior Information Governance Manager, BSI, Ireland
  • Walter van der Weegen - Researcher and Data Scientist, St. Anna Hospital, the Netherlands

 

 
9:00 – 10:30

IVD1: IVDR: Current state – An update on the IVDR implementation

Leader and Chair:

  • Amanda Brown - Head of Regulatory Affairs and Quality, GNA Biosolutions, Germany

The IVD Regulation is finally here! This session offers an update on the current state of play regarding IVDR implementation and it’s supporting infrastructure within the European Union.

During this session we will hear perspectives from Regulatory Agencies, Industry and Notified Bodies in review of what has taken place and changed over the past several months since May 26th. We will cover what has been observed so far and lessons learned, as well as learn about what is coming in the future.

Speaker:

  • Marta Carnielli - IVD Technical Director, Tüv Süd, Germany
  • Claudia Popp - Head EU Regulatory Science and EMA Liaison, Roche, Switzerland
  • Olga Tkachenko - Scientific Policy Officer, European Commission

 

 

10:30 – 11:00

Networking Break
  11:00 – 12:30

MD4: Challenges and opportunities for small companies and start-ups

Chair:

  • Margareth Jorvid - Regulatory Affairs Director, Ilya Pharma, Sweden

Working in a start-up is hard. Bringing a medical device to market is even harder. This session will address the challenges faced by small companies and the impact of the new Regulation (EU) 2017/745 (MDR) on how to CE mark your device. How to do the right things from the start and use the right tools. How to approach and talk to a Notified Body. In the end it is making your device available to the benefits of patients that counts.

Speakers:

  • Theresa Jeary - Technical Specialist & Scheme Manager, BSI, Ireland
  • Natasha Bankowski - Director of Regulatory Affairs and Quality Assurance, Beyond Air, Ireland
  • Oliver Eidel - Founder, OpenRegulatory, Germany
  • Margareth Jorvid - Regulatory Affairs Director, Ilya Pharma, Sweden


 

 
11:00 – 12:30

IVD2: Clinical performance studies under IVDR

Lead:

  • Amanda Brown - Head of Regulatory Affairs and Quality, GNA Biosolutions, Germany

With the implementation of the IVD Regulation this year, one of the biggest impacts for companies both large and small, are the changes to Clinical Performance Studies. This session will cover Clinical Requirements under IVDR and give both Competent Authority and Industry perspectives on implementation to date. We will cover challenges, lessons learned, and best practices, as well as more specialized topics such as PMPF studies, the use of leftover samples, and borderline issues.

Speakers:

  • Dr. Stefan Strasser - Head of Clinical Trials, Institute Surveillance, Austrian Federal Office for Safety in Health Care (AGES), Austria
  • Heike Moehlig-Zuttermeister - VP Intelligence & Innovation, RQM+, Germany
  • Andreas Franke - Chief Operating Officer, TRIGA-S Scientific Solutions, Germany
 

 

  12:30 –  13:10  Lunch Break
  13:10 – 14:40

MD5: How to maintain your medical device on the market and fulfil ongoing obligations in the post-launch phase

Leader and Chair:

  • Natasha Bankowski Director of Regulatory Affairs and Quality Assurance, Beyond Air, Ireland

With all of the complexities of the MDR, other Global Regulations and constant changes, it is difficult enough to achieve a CE certificate or licence approval to launch your product in your target market/s.

As the years go by, the ongoing obligations you must fulfill and the post-market activities to maintain your medical device on the market keep increasing and becoming more challenging and complex.

Post-market surveillance activities even for the lowest risk classes have dramatically increased along with your vigilance requirements. But what about the Eudamed database? What about your Economic Operators and the on-going obligations there? Are you sure about what is required from the QMS and Technical documentation requirements to maintain the product on the market post-launch?

Some companies believe that the work is mostly done when you get the product to the market. This is however, far from the truth and some might say that the work to keep the product on the market post-launch is even more difficult than the pre-market phase.

Speaker:

  • Richard Houlihan - CEO, EirMed, Belgium
  • Heidrun Eberl - Deputy Head, Austrian Agency for Health and Food Safety (AGES), Austria
  • Juliette Cook - Vice President Regulatory Affairs and Quality Assurance, Implantica, Switzerland

 

 
13:10 – 14:40

IVD3: IVDR for small companies and start-ups

Lead:

  • Amanda Brown - Head of Regulatory Affairs and Quality, GNA Biosolutions, Germany

The challenges small companies and start-ups face when looking at the daunting challenge of launching a product under IVDR can be stressful. From understanding the steps of the conformity assessment process, to what are the requirements and how to get clinical data, and where to find resourcing to perform these tasks, represent just a few of the struggles that companies may face. Throughout this session we will look at answering these questions, present a Case Study from a small company that has implemented IVDR, and point to resources to support professionals in this area.

Speakers:

  • Marta Carnielli - IVD Technical Director, Tüv Süd, Germany
  • Alexandra Stamati - Quality Assurance and Regulatory Director, Medicon Hellas SA, Greece

 

 

   End of the Medical Devices/IVDs Symposium  

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TOPRA Symposium 2022
Hilton Vienna Park, Vienna, Austria
Am Stadtpark 1, 1030

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