2018 Programmes

The 2018 Annual Symposium programmes are taking shape. The latest programmes for the Human Medicines, Medical Devices/IVDs, Veterinary Medicines, Professional Competencies and SME sessions below.

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Monday, 1 October

10.30 – 11.30   Registration, exhibition and refreshments
11.00  Introduction to Medical Devices Symposium 

 

SESSION 1: Update on Progress and Preparation for the Medical Device and In Vitro Device Regulations

Nearly half way through the transition period for the Medical Device Regulation (MDR) – and well underway for transitioning to the In Vitro Diagnostic Regulation (IVDR) – where are we now? A status update on the progress of the MDR/IVDR, Notified Body (NB) designation and EUDAMED will be shared and discussed by key players. How far along are the organisations with implementing the new regulations, are sufficient resources available and will the timelines hold? 

Leader: Sofia Faraasen – Technical Specialist and Certification Scheme Manager, BSI, Sweden 
Chair: Helena Dzojic – Head of Medical Devices, Swedish Medical Products Agency (MPA)

11.05 Introduction 
11.10 

Progress on MDR/IVDR – European Commission perspective

  • MDR/IVDR update – What is the current status? 
  • Implementation priorities
  • Adaptations required in a wider global context
  • Resources and timelines
Speaker: Erik Hansson - Deputy Head, Unit D/4 - Health Technology and Cosmetics, European Commission
 
11.30 

Progress on MDR/IVDR – Competent Authority perspective 

  • MDR/IVDR – Status on the national level
  • Cooperation of implementation
  • The work of CAMD
  • Resources and timelines  

Speaker: Niall MacAleenan - Deputy Director and Head of Medical Devices Department, Health Products Regulatory Authority (HPRA) - Ireland

11.50 

Extended panel discussion 

Panellists: 

  • Sofia Faraasen – Technical Specialist and Certification Scheme Manager, BSI Group, Sweden
  • Ian Carmichael – IVD Technical Specialist, Medical Directives Team, IVD Notified Body, LRQA, UK
  • Giovanni Di Rienzo - Global Director - Cardiovascular Focus Team, TÜV SÜD Product Service, UK
12:30  Lunch in Exhibition Hall (with option to join Human Medicines Symposium to hear TOPRA annual lecture over lunch)

SESSION 2 - CHOICE BETWEEN DEVICE AND IVD STREAMS 
 
SESSION 2 – DEVICE STREAM
Gathering Clinical Evidence, Evaluating Clinical Data and Determination of Post-market Clinical Follow-up under the MDR
Additional clinical evidence will be needed for many devices under the MDR. Stricter rules will apply to clinical data requirements for new products as well as devices already on the market subject to mandatory re-registration under the MDR. This session will explore clinical evaluation requirements and how post-marketing surveillance should be used to update clinical evaluation reports. 

Chair and Leader:   Beata Wilkinson, Medical Director – CERs, Cactus Communications, UK/India/USA  
 
13.20 

Introduction
Speaker: Robert van Boxtel – Principal Consultant, Medical Device Project BV, the Netherlands

13.25 

Clinical trial agreements – guidance on contracting under MDR

  • Research regime
  • MDR vs ISO 14155
  • Impact of the General Data Protection Regulation (GDPR) on agreements for the performance of clinical research and informed consent
Speaker: Cécile van der Heijden – Attorney-at-law, Axon Lawyers, The Netherlands
 
13.45 

Clinical evaluation and how it determines adequacy of clinical evidence 

  • Clinical evaluation requirements
  • Sources of clinical data
  • Assessment of medical device benefits
Speaker: Beata Wilkinson – Medical Director – CERs, Cactus Communications, UK/India/USA
 
14.05 

Post-market surveillance and how it should update clinical evaluation reports

  • Post-market clinical follow-up (PMCF) planning based on clinical evaluation
  • Post-market surveillance planning
  • Data gathering and analysis
  • Updating clinical evaluation and re-assessing benefits/risk
Speaker: Robert van Boxtel – Principal Consultant, Medical Device Project B.V., the Netherlands 
 
14.25  Panel discussion
   
SESSION 2 – IVD STREAM 
IVD Performance Evaluation Requirements
The IVD Regulation has increased requirements for Performance Evaluation to confirm conformity with the relevant General Safety and Performance Requirements. This session will review the scientific validity, analytical performance and clinical performance requirements that manufacturers will have to meet and the evidence required in the technical documentation to meet the requirements of Annexes XIII and XIV of the IVD Regulation. 

Leader: Nick Baker – Head of IVD Notified Body, LRQA, UK
Chair:  Ian Carmichael – IVD Technical Specialist, LRQA, UK

13.20  Introduction 
13.25 

Performance Evaluation – New requirements under the IVDR

  • What evidence is needed for IVDR?
  • When will a study be required?
  • What are the general requirements for a study?
  • What are the additional requirements for a CDx study?
Speaker: Stephen Lee – Senior Regulatory Policy Manager – IVD, Devices Division, MHRA, UK
 

13.45 

Requirements for Clinical Evidence

  • Practical implications for IVD manufacturers of the three pillars of clinical evidence: scientific validity, analytical performance, clinical performance
  • Outsourcing strategies for scientific validity and clinical performance
  • How the Clinical Evidence Report ties into the requirements for Post-Market Performance Follow-up (PMPF). Differences between PMS and PMPF requirements and processes
Speaker: Maurizio Suppo – Principal Consultant, Qarad
 
14.05  Panel discussion 
14.50  Break 

SESSION 3 – CHOICE BETWEEN DEVICE AND IVD STREAMS 
 
SESSION 3 – DEVICE STREAM
Digital Health and the New General Data Protection Regulation (GDPR)
There are exciting opportunities for digital health with medical devices, with increasing connectivity and convergence with medicinal products enabled by software not imagined when the medical device directive was published. Systems are increasing in complexity, with artificial intelligence coming into play. Software developers may not be familiar with medical device regulations; there are also fears and risks that need to be addressed regarding safety, security and privacy. This session will consider the challenges of regulating in this fast-moving space, including the impact of the General Data Protection Regulation on the medical device sector and how to successfully navigate the minefield of applicable regulations.

Leader and Chair: Janine Jamieson – JCombinations and IPQ Publications, Sweden 
 
15.15  Introduction 
15.20 

Competent Authority perspective on digital health and software medical devices

  • Impact of the MDR on software as a medical device
  • Complex systems
  • Regulatory guidance
Speaker: Mats Artursson – Assessor, Medical Products Agency, Sweden
 
15.40 

Industry perspective on GDPR preparations and data protection

  • How does cybersecurity relate to GDPR?
  • How to integrate security and safety risk management
  • Framework of applicable standards
  • Transparency when dealing with patient data
Speaker: Jaap Noordmans – Senior Consultant, Qserve Group, the Netherlands
 
16.00 

Case study: Coala heart monitor

  • How the company successfully took a new, digital medical device to market
  • Using all tools and support available - lessons learned
  • Preparing for the MDR and GDPR
Speaker: Philip Siberg – CEO and co-founder, Coala Life AB, Sweden

16.20  Panel discussion
16.45  Break 
17.15  Join Human Medicines Symposium for Brexit session 
   
SESSION 3 – IVD STREAM 
IVD Technical Documentation Requirements
Under the IVD Directive, the majority of IVD devices are self-certified, therefore, many manufacturers will not have experience of submitting technical documentation for Notified Body review. The date of application of the IVD Regulation is 26 May 2022. To place a product on the market after that date, manufacturers will have to prepare the applicable technical documentation and undergo Notified Body review. This session will cover the additional technical documentation requirements needed to show compliance with the IVD Regulation.

Leader: Nick Baker – Head of IVD Notified Body, LRQA, UK
Chair:  Ian Carmichael – IVD Technical Specialist, Medical Directives Team, IVD Notified Body, LRQA, UK
 
15.15  Introduction 
15.20 

IVDR Technical Documentation Requirements

  • Existing documents that can be updated
  • New documents required:
    • Performance Evaluation Report (scientific validity, analytical and clinical performance)
    • Post-market Surveillance Plan
    • Post-market Performance Follow-up
    • Periodic Safety Update Report
Speaker: Antonia Claasz - Senior Consultant (Medical Devices - Regulatory Affairs and Quality Assurance), Symbioteq, Sweden
 
15.40 

Preparing Technical Documentation under the IVDR – Challenges Faced by a Manufacturer

  • Performance Evaluation Reports for Legacy Products – New or Reformatted Reports?
  • “Clear, organised, readily searchable and unambiguous”
  • Impact of new IVDR requirements on  products already registered globally
  • Compliance with (Not So) Common Specifications
Speaker: James Kelly - Executive Director, Regulatory Affairs, Cepheid, USA
 
16.00  Panel discussion 
16.45  Break 
17.15  Join Human Medicines Symposium for Brexit session 

SESSION 4  Brexit 
(This is a joint session with the Human Medicines Symposium)
The impact of the UK’s decision to leave the EU continues to have significant ramifications for the pharmaceutical and medical devices industry as well as the EMA, the National Competent Authorities and the Regulatory Network. The UK have made it clear that continued close cooperation in the regulation of medical products is the desired outcome, but negotiations continue between the European Commission and the UK government and the final impact on the healthcare industries is still to be clarified. In the meantime, the EMA prepare to relocate to Amsterdam, which in itself will have a major impact on all stakeholders. This session will consider preparations being made by the EMA and all European Agencies to ensure the continued functioning of the network. Preparations required by the Pharmaceutical and Medical Device Industries will also be discussed. 

Leader: Sharon Gorman – Director, EU Regulatory Policy, Pfizer, UK
Chair: David Jefferys - Senior Vice President, Eisai, UK
 
17.15 

Introduction

  • What is known to date and what is still to be determined
Speaker: David Jefferys – Senior Vice President, Eisai, UK 
17.25 

Progress and impact of EMA relocation and impact on current and future centralised products
Speaker: Marie-Hélène Pinheiro – Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders & Communication Division, EMA

17.35 

Impact on the Regulatory Network

  • Impact on MRP/DCP products
  • Impact on the national agencies
Speaker: Marie Gårdmark – Director of Licensing, Swedish MPA
 
17.45 

Pharmaceutical industry views and the preparations required by industry
Speaker: Virginia Acha - Executive Director, Regulatory Policy, Regulatory Affairs International, MSD; and member of  EFPIA Brexit and ABPI/BIA Brexit taskforces

17.55  Medical device industry views and the impact for the devices industry
Speaker: Maurizio Suppo – Co-owner & Principal Consultant, Qarad 
 
18.05  Panel discussion
Additional panellist: Jonathan Mogford – Policy Director, Medicines and Healthcare products Regulatory Agency, UK 
 

18.45 Networking Reception in Exhibition Hall   

Tuesday, 2 October

08.55  Introduction to Day 2 - TOPRA speaker

SESSION 5 – Medicinal Products with Integral Medical Devices: Bringing Two Worlds Together
(This is a joint session with the Human Medicines Symposium)
Each year we are seeing progressively more drug-device combinations, often associated with self-administration to treat chronic diseases. Such combinations can be pre-filled, integrated, single-use solutions for patient/user convenience. These non-CE marked medicinal product configurations are the subject of much industry and regulator debate, as interpretation of the applicable regulations, standards and guidelines is needed. The Medical Device Regulation (EU) 2017/745 will amend the Medicinal Product Directive (2001/83/EC) via Article 117, and as of 2020 place greater focus on the safety, performance and usability of a delivery device constituent. A Notified Body opinion on integral device constituents will be required in many cases, raising questions and concerns across industry. In this session we aim to share some different views from both industry and regulators on the approaches to approval of such products. 

Leader and Chair: Mark Chipperfield – Corvus Device Ltd, UK

09.00  Introduction  
09.05 

A regulator’s view – Observations and reflections from reviewing combined products

  • Recent issues and regulator expectations for medical device constituents
  • Update on CHMP guidance development
  • Advice to manufacturers on preparing for Article 117
Speaker: Armin Ritzhaupt - Regulatory Affairs, European Medicines Agency 
09.25 

A consultant view – Observations from supporting industry in gain combined product approvals 

  • Reflections on the approach in Switzerland
  • Bringing together device Clinical Evaluation and drug Clinical Investigation
  • Who reviews what?
Beat Steffen - Founder and CEO at Confinis AG
 
09.45 

An industry perspective - Experiences with EU review of integrated products

  • Past difficulties with obtaining ‘voluntary’ opinions to support MAA
  • Anticipated challenges with the Art. 117 requirements
  • Expectations and needs to smooth the future path
Speaker: Stephen Dew - Associate Director, Regulatory Affairs CMC Medical Devices and Combination Products at Biogen Idec
 
10.05 Panel discussion 
10.30  Break 

 


SESSION 6 – Developing Cooperation at the Interface Between Medicinal Products and Medical Devices 
(This is a joint session with the Human Medicines Symposium)
In recognition of the increasingly blurred distinction between medicinal products and medical devices, the Heads of Medicines Agencies (HMA) and Competent Authorities for Medical Devices (CAMD) are developing further cooperation to address the challenges of merging regulations. A diverse range of products are being considered, from over-the-counter substance-based medical devices to combination products, off-label use of medicines with CE-marked devices, in vitro and companion diagnostics and combined ATMPs. In this session, we will hear an update on progress of this cooperation initiative at both operational and strategic level and the challenges of classification and working at the drug-device interface from regulator and industry perspectives. 

Leader and Chair: Janine Jamieson – JCombinations and IPQ Publications, Sweden

11.00  Introduction 
11.05 

Cooperation on medical device regulation, combination and borderline products

  • Cooperation between authorities/CAMD/implementation roadmap
  • HMA-CAMD cooperation
  • Increasing convergence and cooperation with medicines regulators
Speaker: Niall MacAleenan - Head of Medical Devices Department, Health Products Regulatory Authority (HPRA), Ireland and member of CAMD EG 
11.25 

Industry perspective on preparations for Rule 21, substance based medical devices

  • Background and debate about MDR Rule 21, substance-based medical devices
  • Changes in classification for currently marketed products: upclassification of Class I devices
  • Consultation procedure with relevant medicines authorities or EMA in the context of the conformity assessment
  • Regulatory expectations and industry guidance in development
Speaker: Maud Perrudin - Deputy Director, Association of the European Self-Medication Industry (AESGP), Belgium
11.45 

Classification of therapies incorporating tissues and cells/blood

  • Medicinal products or medical devices – what determines classification?
  • How do clinical trial requirements differ?
  • Experience of combined ATMPs with device components
Speaker: Ilona Reischl - Vice-chair CAT and Head of Clinical Trials for Medicines and Medical devices, AGES, Austria
12.00  Panel discusssion
Guest panellist: Armin Ritzhaupt - Regulatory Affairs, European Medicines Agency 
12.30  Close of Medical Devices/IVD Symposium - Attendees are invited to attend the afternoon's Professional Competence sessions 


  

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