Programmes

See below for the most up-to-date programme details for the 2021 TOPRA Symposium. Additional information about these sessions will be announced as they are finalised.

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Medical Devices / IVDs Symposium 2021

23 September

 

All times CEST (GMT+2)
11:15 – 11:55

TOPRA Annual Lecture: From ‘knocking on the door’ to co-creation: 25 years of patient engagement in R&D
Virginie Hivert, Therapeutic Development Director, EURORDIS France

Patients and their families are strong advocates and active players when it comes to developing treatment for their own diseases or those of their loved ones. This session is the opportunity to share some thoughts, experiences and insights from the point of view of a patient representative on the importance of educating all the stakeholders involved, the evolution and current trends in patient engagement.

12:00 – 13:00

TOPRA Annual Review Meeting

We invite all TOPRA members to attend the Annual Review Meeting to hear about TOPRA’s financial results for the previous year, key activities and achievements for the current year and plans for the next year. The meeting is an opportunity to be introduced to new Board Directors and celebrate the various awards and honours conferred by the Board to recognise significant contributions within our valued TOPRA Community.

13:00 – 13:45 Networking Break
13:45 – 15:15

MD1: MDR implementation – is there a future for legacy devices?
Leader and Chair: Margareth Jorvid, CEO, Regulatory Affairs & Quality Assurance at Methra Uppsala AB, Sweden

Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).This session will address the importance of not waiting to transfer these products into the MDR. How will Legacy Devices will be identified in EUDAMED and how will Unique Device Identifiers for the Legacy Devices will be generated/assigned. What are the MDR implicationns for these devices if not successfully transferred in time? What are the implications for health care and patients if they have to be taken off the market?

13:45 Introduction

13:50 MDR Implementation - Is there a future for Legacy Devices? - Darek Foit, Director, Medical Devices Department, State Institute for Drug Control (SUKL), Czech Republic

  • What is a Legacy device? Examples
  • Conditions and UDI
  • Economic operators and timelines

14:10 Legacy Devices – Key considerations when planning MDR Application - Theresa Jeary, Technical Specialist & Scheme Manager, BSI, Ireland

  • Planning submissions and communication with NB
  • Timescales involved in Conformity Assessment process
  • Common misconceptions and key considerations

14:30 A perspective from the medical device industry - Miroslav Palát, President, Czechmed, Czech Republic

14:50 Panel discussion 

15:15 – 16:00

Networking Break
16:00 – 17:30

MD2: Global development strategy – Which market should you go to first?
Leader and Chair: Natasha Bankowski, Head of Global Regulatory Affairs and Pharmacovigilance, Kora Healthcare, Ireland

For medical device manufacturers, gaining access to multiple major markets is important for the success of the company. Global differences in regulations and requirements typically result in a long and costly path to global regulatory approval.

Taking a strategic approach in achieving regulatory approval can be an effective tool in reducing the compliance burden facing medical device manufacturers.

Manufacturers may find that first obtaining FDA or EU approval for access to the US or European market can result in leveraging documentation required for the prompt and efficient review of new device applications in other markets.

The decision where to start (whether EU first, US first, or simultaneously) has different advantages that need to be considered and must be assessed on a case-by-case basis, depending on the characteristics and features of your device, your company setup, and the corresponding regulatory control.

For the last number of years, many companies would have obtained EU approval first before approaching the FDA/ROW markets. However, with the introduction of the EU MDR and the United Kingdom leaving the European Union, more and more companies are now choosing the US as the preferred initial market due to the additional restrictions and complexities that the EU MDR and Brexit have brought.

16:00 Introduction

16:05 US as first choice for your new medical device rather than EU! Is this a good or bad choice? – Michelle Lott, Regulatory Strategist, Principal and Founder, Lean RAQA, US

  • Need for a market analysis to make a business case for the EU/UK market compared to US with regulatory AND reimbursement considerations
  • Considerations of companies holding valid MDD certs vs. companies new to the EU market
  • Compare and contrast bringing a product to market with the FDA vs Notified Body

16:25 How does the MDR impact your overall global development strategy? – Bassil Akra, Chief Executive Officer, AKRA TEAM, Germany

  • Specific and evidence-based claims
  • Higher Clinical and PMS Requirements
  • Long certification timelines impacting registration and non-EU market access

16:45 As the UK has now left the United Kingdom with NI still following EU rules? Where does UK now fit into your global development strategy? – Monisha Phillips, Head of MHS Certification Body, TUV SUD, UK

  • What are the UKCA requirements for medical devices?
  • When do manufacturers need to act?
  • What next? 
17:05 Panel discussion

 

24 September

 

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 session.

10:00 – 11:30

MD3: Digit(al)isation: How to bring paradise into regulatory work
Leader and Chair: Martin Witte, Global Director Focus Team, Active Implantable & Cardiovascular Devices, TÜV SÜD Product Service, Germany

During the past months we all experienced the potential of digitalisation and the benefits from using digital tools. The medical device ecosystem is an innovative industry when finding technically advanced solutions for improving patients’ lives. However, our ecosystem sometimes lacks effective digitalisation, especially when it comes to setting up a technical documentation smartly. Traditionally, technical documentations were created as binders filled with paper, sometimes dozens of binders for one product. That has changed over the past few years. Today, the leading principle is a collection of PDFs or one large PDF provided in a folder structure. Such an approach is a “digitisation” step. “Digitalisation” would result in an improved use of data and will result in a boost of efficiency but also requires a lot of preparation and investments. In this session we will learn how a notified body, a manufacturer, and a think-tank are approaching the topic of digitalisation of the technical documentation. Learn further how all data in an organisation is linked and how you can benefit from a smart data structure in your daily work life.

Speakers:

  • Martin Witte, Global Director Focus Team, Active Implantable & Cardiovascular Devices, TÜV SÜD Product Service, Germany
  • Sarah Panten, Product & Strategic Business Development and Managing Partner, avasis, Germany
  • Markus Pöttker, Post-Market Surveillance Lead - Safety & Surveillance, Smith & Nephew, Switzerland
9:45 – 11:30

IVD3: EU Implementation: Current State

Leader and Chair: Amanda Brown, Head of Regulatory Affairs and Quality, GNA Biosolutions, Germany

This session will focus on evaluating the current state of the IVD Regulation implementation in the European Union. Starting with understanding the importance of the IVDR and seeing the Competent Authority perspective, we will then move on to comprehend where we stand and what lessons have been learnt from the IVDR reviews so far by the Notified Bodies. As the deadline for the new IVDR is soon approaching, this represents the perfect opportunity to look at the current situation, exchange ongoing best practices and see what the major hurdles at the moment are.

Speakers:

  • Olga Tkachenko, Scientific Policy Officer, Unit B6, DG SANTE, European Commission
  • Julien Senac, Global Director, IVD Focus Team, TÜV SÜD
  • Maurizio Suppo, Vice-President, qarad, Belgium
  • Thomas Wejs Møller, Danish Medicines Agency, Denmark
11:30 – 12:15 Networking Break
12:15 – 13:45

MD4: Clinical investigations - Is the coordinated CA assessment the future?

Leader and Chair: Alwin van den Broek, Project Manager and Data Protection Officer, Avania Clinical, the Netherlands

Where a clinical investigation is to be conducted in more than one Member State, the Sponsor should have the possibility of submitting a single application in order to reduce administrative burden. Whereas the aim is to reduce the administrative burden for the applicant and the workload for the Member States, ensuring consistent assessments as well as the implementation of an uniform application process is still a challenge. During this session the attendee will learn about the current status of the single application process, the voluntary character for Member States as well as the impact on strategy for MedTech Companies that are designing their Investigations. This session will be concluded with a discussion and the outlook on the future from the expert panel.

Speakers:

  • Tomáš Kučera, Medical Devices Section, State Institute for Drug Control (SUKL), Czech Republic
  • Mathias Fink, Manager Clinical Focus Team North America, TÜV SÜD, US
  • Amy Bennett, Quality Manager, Orthox, UK
13:45 – 14:30 Networking Break
 

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

14:30 – 16:00

HM9MD5: Innovation in drug-device combinations – how to navigate a complex regulatory environment

Leader and Chair: Bjorg K. Hunter, Department manager, Regulatory Affairs NextGen Drug-device, Novo Nordisk, Denmark

Innovation in drug delivery has been on the rise in recent years. This has been a result both of a more patient centric focus, new technology development and a wish for more and better at home treatment. Further to this the trend has been to integrate the medicine and the delivery device into one product to reduce user steps and for easier access. The introduction of the Final Rule of Combination products in the United States as well as the update to the MDR and introduction of Article 117 in Europe are examples of regulatory pathways also changing to meet the challenges in regulating these new innovative solutions. However, as medicines are still primarily regulated though the medicinal offices in the Health Authorities it becomes very complex to navigate regulatory interactions for innovative drug-device combination products. This session will focus on discussions between regulators and industry to share best practises and ideas on how it is possible to have meaning interactions on early innovation.

Speakers:

  • Christelle Bouygues, European Medicines Agency (EMA)
  • John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, US FDA
  • Manfred Maeder, Global Head Device Development & Commercialization, Novartis, Switzerland

Panellist:

  • Nada Alkhayat, Policy Officer – Medical Devices, Unit B6, DG Sante, European Commission

IVD5: Help! How do I Implement IVDR? I've Submitted My Files - What's Next?

Leader and Chair: Amanda Brown, Head of Regulatory Affairs and Quality, GNA Biosolutions, Germany

The date of application is drawing closer and you might still have questions that have not been answered. How to prepare my application document? What are the expectations for performance evaluation or post-market clinical follow-up? How will the new IVD Regulation impact global markets? This 2-in-1 session will focus on offering guidance both to those who are still working towards IVDR implementation, as well to those looking at strategic issues.

Speakers:

  • Bassil Akra, Chief Executive Officer, AKRA TEAM, Germany
  • Erica Conway, Global Head- IVD Medical Devices, BSI, UK
  • Manoja Ranawake, Vice President, Regulatory Affairs – EMEA, Becton Dickinson, Switzerland
  • Julien Senac, Global Director, IVD Focus Team, TÜV SÜD
   End of the Medical Devices/IVDs Symposium  

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TOPRA Symposium 2021

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