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 


11.00 - 12.30: 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 MDR (and well underway for transitioning to the IVDR), where are we now? A status update on the MDR / IVDR progress, NB accreditation 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?

Speakers:
- Niall MacAleenan - Deputy Director and Head of Medical Devices Department, Health Products Regulatory Authority (HPRA) - Ireland
-
Erik Hansson - Deputy Head, Unit D/4 - Health Technology and Cosmetics, European Commission
- other speakers to be announced


12.30 - 13.15
Lunch
in Exhibition Hall (with option to join Human Medicines Symposium to hear TOPRA annual lecture over lunch)

13.20 - 14.50:  Session 2*

(*Choice between Device and IVD stream sessions)

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.

Speakers:

- Beata Wilkinson - Head of Regulatory Services, Cromsource CRO, UK/Italy
Robert van Boxtel - Principal Consultant, Medical Device Project, The Netherlands
- Cécile van der Heijden - Attorney-at-law, Axon Lawyers, The Netherlands

or

IVD Performance Evaluations 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.  

Speakers:
- Stephen Lee - Senior Regulatory Policy Manager - IVD, Devices Division, MHRA, UK

Maurizio Suppo - Co-owner and Principal Consultant, QARAD
 


15.15 - 16.45:  Session 3*

(*Choice between Device and IVD stream sessions)

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.

Speakers:
- Jaap Noordmans - Senior Consultant, Qserve Group, The Netherlands
- Philip Siberg - CEO and Co-founder, Coala Life AB, Stockholm, Sweden 
- other speakers to be announced


or

IVD Technical Documentation Requirements

Under the IVD Directive, the majority of IVD devices are self-certified, therefore, many manufactures 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 product on the market after that date, manufacturer’s will have to prepare the applicable Technical Documentation and undergo Notified Body review.  This session will cover the additional Technical Documentation requirements that manufacturers will have to prepare for all products to show compliance with the IVD Regulation.

Speakers:
- Antonia Claasz - Senior Consultant (Medical Devices - Regulatory Affairs and Quality Assurance), Symbioteq, Sweden
- Sophie Pernice - Senior Director, Quality Systems and Regulatory Compliance, Cepheid, Sweden



17.15 - 18.45: 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.

Introduction: 
David Jefferys - Senior Vice-President, Eisai, UK

Speakers:
- Marie Gårdmark - Director of Licensing, Medical Products Agency, Sweden
- Alan Morrison - Vice-President, International Regulatory Affairs, MSD
- Maurizio Suppo - Co-owner and Principal Consultant, QARAD
- Marie-Helene Pinheiro - Industry Stakeholder Liaison, Corporate Stakeholder Department, Stakeholders & Communication Division, EMA
- other speakers to be announced

18.45
Networking drinks

Tuesday, 2 October

09.00 - 10.30: 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 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.

Speakers:
- Beat Steffen - Founder and CEO at Confinis AG
- Stephen Dew - Associate Director, Regulatory Affairs CMC Medical Devices and Combination Products at Biogen Idec



11.00 - 12.30: 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.

Speakers:
- Maud Perrudin - Deputy Director, Association of the European Self-Medication Industry (AESGP), Belgium
- Ilona Reischl - Vice-chair CAT and Head of Clinical Trials for Medicines and Dedical devices, AGES, Austria
- Niall MacAleenan - Deputy Director. Head of Medical Devices Department at Health Products Regulatory Authority (HPRA)
- other speakers to be announced


12:30 - Close of Medical Device/IVD Symposium
Attendees are invited to attend the afternoon's Professional Competencies sessions.

  

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