Introduzione

The MedDev Day keeps the discussion going!
Enrol in the online event to take place in 21st – 24th September 2021!
A 4-day event to discuss ongoing hot topics in the world of Medical Devices (MDs), In-Vitro Diagnostics (IVDs) and Software Medical Devices (SaMD).

The regulations are already tough – and getting tougher. The MDR and the IVDR place more emphasis on a life-cycle approach to safety, backed up by clinical performance data. Both regulations present stringent requirements for Notified Bodies, control and monitoring by competent authorities. Within this context, staying up to date with the latest news and discussions in the global medical device industry is a complex task.

The MedDev Day, organized by LS Academy has reached its third edition, and will once again serve as a central meeting place for the medical technology industry, bringing together lecture forums, interviews, workshops and networking opportunities. The event will be 360-degree overview of the evolving context of medical devices, in-vitro-diagnostics and software.
Hot topics in discussion will include:

  • Strategic approach to the claims in the clinical evaluation and MDR requirements
  • RWD & RWE in clinical evaluations
  • Benchmarking clinical data for better study designs
  • How to implement Post-Market Surveillance processes following MDR art. 88
  • IVDR and technical documentation
  • Regulatory management of medical devices under the MDR
  • Cybersecurity of medical devices
  • Scientific validation of algorithms

«Over the past 10 years, the medical device industry has been growing on average 4.2% per annum in the European medical device market. (…) Medical technology is characterized by a constant flow of innovations, which are the results of a high level of research and development within the industry, and of close cooperation with the users (1).»

Scientific Board
Francesco Dell'Antonio - Vice President, Regulatory Affairs and Quality Assurance at Quanta System
Laura Michellini -Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Sascha Wettmarshausen - Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Laura C Collada Ali - MedDev Day Scientific Coordinator, LS Academy

Who should attend?
The event is designed for professionals in the field of Medical Devices, devoted to departments such as:

  • Clinical Operations
  • Product Managers
  • Regulatory Affairs
  • Quality Assurance/Control
  • Risk Management
  • Medical Device Engineering
  • Device vigilance
  • R&D
  • Medical Affairs
  • Medical Writring

from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.

(1)MedTech Europe. The European Medical Technology Industry in figures 2020.
Available here: https://www.medtecheurope.org/wp-content/uploads/2020/05/The-European-Medical-Technology-Industry-in-figures-2020.pdf
Programma

5 sessions to choose from based on your interests:
SESSION 1 | General: Medical Devices Clinical Evaluation & Clinical Investigation
SESSION 2 | General: Post-market Surveillance
SESSION 3: In-Vitro Diagnostics
SESSION 4: Regulatory Management
SESSION 5: Software Medical Devices

Complete programme available soon
Morning sessions: from 10:00 AM to 12:30 PM CET
Afternoon sessions: from 2:00 PM to 4:30 PM CET

21 September 2021
Morning
SESSION 1 | General: Medical Devices Clinical Evaluation & Clinical Investigation
To claim or Not to Claim - Practical Considerations on How to Approach Claims within the Clinical Evaluation of a Medical Device
Silvia Casagrande - Clinical Evidence Manager at Orthofix SRL

The clinical evaluation process allows a manufacturer of a medical device to evaluate if there is sufficient clinical evidence to declare compliance with safety, performance and benefit / risk ratio essential requirements. Within this process the claims made by the manufacturer are a fundamental input that should be taken into consideration at a very early stage, namely during planning and scoping of the clinical evaluation. Indeed, the claims made embody the foundations for the entire process.
The aim of this session is not only to discuss the controversy under the definition of “claim”, but also to provide practical considerations and best practices on how to analyze and find correct sources to substantiate claims. In particular, we will discuss:

  • The different types of claims
  • The importance of claims in the clinical evaluation process
  • Sources for substantiation of claims: clinical data and more
  • The re-evaluation of claims in the post market phase
  • Considerations for legacy medical devices transitioning to MDR
Benchmarking Clinical Data for Medical Devices to improve your Study Design
Jasminka Roth - Founder and Director of The Tao of Excellence

Putting a medical device on the market is widely seen as a linear process with two separate stages, that of pre and post-market. These tend to be independently managed, and although they rely one another they are unlikely to know each other’s regulatory requirements or the ways that they could collaborate to help a product to thrive on the market. The observational data of real-world evidence (RWE) has not traditionally been a focus for pre-market clinical teams. Now however, the EU’s medical device regulation (MDR) and in vitro diagnostic medical device regulation (IVDR) radically reinforces the regulatory requirements for clinical trials for pre and post-marketing, citing these as vital to ensuring the safety and performance of a product on the market.

New technology now enables us to review, analyse and utilise clinical data from real-world applications for regulatory purposes, health tech assessments and more. We can design clinical trials with the RWE manuscript in mind and in turn use RWE to influence new clinical trials that can support the lifecycle of a product on the market.

Whilst this talk will define the framework of these new regulatory requirements, it will also highlight the fact that RWE can now be used and shared to support the regulatory requirements for a device.

Afternoon
SESSION 2 | General: Post-Market Surveillance
PMCF under the MDR: the Latest Insights
Wiebe Postma - Sr Consultant & CRO Lead at Qserve CRO

The EU Medical Device Regulations reinforce the rules on clinical evidence and post market surveillance for medical devices. Manufacturers are required to perform Post Market Clinical Follow-up (PMCF) as a continuous process that updates the clinical evaluations of their devices with new clinical data. A wide range of PMCF activities can be used to collect this data including clinical investigations, registries, surveys and literature reviews. The PMCF methods vary in the type and quality of clinical evidence that can be collected. In this presentation we will review the PMCF requirements and, based on recent experience with PMCF planning, data collection and notified body acceptance, we will give insights in how to identify and address clinical data gaps using appropriate PMCF methods. Lastly, the role of PMCF in life cycle management will be discussed.

22 September 2021
Morning
SESSION 3: In-Vitro Diagnostics
Technical Documentation for IVDs according IVDR: a Case-Study
Stefanie Giesener - Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, Germany

How have manufacturers implemented the IVDR requirements into their Quality Management System?

This presentation will give an overview of the regulatory requirements followed by examples to demonstrate how a manufacturer has implemented the requirements in its QMS:
The individual elements of the technical documentation, where they come from, what they must contain will be explained and demonstrated with examples.
A deep dive into the challenges for a manufacturer to fulfil those requirements and adjust existing processes and structures. Differences based on risk classification and the resulting consequences.

The lecture concludes with a question and answer session.

Post-Market Surveillance for In-Vitro Diagnostic Medical Devices
Marta Carnielli - Technical Officer IVD at TÜV SÜD

The presentation will focus on:

  • An overview of the PMS requirements under the IVDR and their impact on Technical Documentation
  • Current status of guidance on PMS for IVDs: what guidance documents are already available and which are still expected after the IVDR Date of Application
  • Notified Body perspective
23 September 2021
Morning
SESSION 4: Regulatory Management
24 September 2021
Morning
SESSION 5: Software Medical Devices
Cybersecurity Requirements for Software as Medical Device (SaMD)
Leon Doorn - Head of Regulatory Compliance [PRRC, DPO] at Aidence

During this session we will take a deep-dive into the requirements around Cybersecurity for medical devices and touch on the definition of requirements, testing and risk management.
Among others, we will address:

  • What are the sources for cybersecurity requirements for SaMD (MDR 2017/745, FDA, other)
  • Which are the requirements coming forth from Medical Device Standards (e.g. ISO 27001, IEC 82304, other)
  • What do you need to consider with regards to Security Risk Management for SaMD?
  • Are there specific risks for AI SaMD?
  • How do you validate Cybersecurity for medical devices?
  • How does your cybersecurity approach link to the Clinical Evaluation Report (CER)?
Relatori
Francesco Dell'Antonio
Info Scientific Board

Francesco Dell'Antonio

Vice President, Regulatory Affairs and Quality Assurance at Quanta System
Francesco Dell’Antonio, VP regulatory & quality of Quanta System Spa (El.En Group), biomedical engineer with 15 years experience in the medical device industry in either notified body and manufacturing companies. Strong expertise in complex active medical devices with software (in particular medical laser devices), with a high focus on the access to key regulated markets (EU, US, Korea, Japan, Canada, Brazil etc), with impressive success track in international approvals.
Laura Michellini
Info Scientific Board

Laura Michellini

Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Graduated in Chemistry and Pharmaceutical Technologies at the University of Genoa, she has more than twenty years of experience in the field of CROs. She has worked as Project Manager for numerous clinical projects for the most important pharmaceutical companies and for Health Institutions. After having held the role of Clinical Operation Manager at a CRO for some years, Laura is now the Scientific Director of Latis Srl and of Elle Research Srl, two CROs that deal with the design and conduct of pre and post-market clinical studies with medical devices, supporting manufacturer in the acquisition of clinical data on their products.
Sascha Wettmarshausen
Info Scientific Board

Sascha Wettmarshausen

Head of Regulatory Affairs at VDGH e.V. (German IVD-Association)
Sascha Wettmarshausen was involved in the entire legislative process of the IVDR and in constant contact with the EU Parliament, the Council and the Commission. At the VDGH, Mr. Wettmarshausen is responsible for the entire area of regulatory affairs (7 committees and working groups) and is heavily involved with the European association Medtech Europe (MTE). At MTE he holds the position of the Vice-Chair of the Regulatory Affairs Committee and is involved in 5 further working groups. Furthermore, he was involved in various guidance documents and is in close contact with the German Notified Bodies and other stakeholders.
Arkan Zwick
Info Scientific Board

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific. Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.
Marta Carnielli
Info Speaker

Marta Carnielli

Technical Officer IVD at TÜV SÜD
Marta Carnielli works for TUV SUD as IVD Technical Officer; in this role, she is responsible to gather and distribute regulatory information in the IVD field, represent TÜV SÜD in relevant regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group. Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department. In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.
Silvia Casagrande
Info Speaker

Silvia Casagrande

Clinical Evidence Manager at Orthofix SRL
Dr. Silvia Casagrande works as Clinical Evidence Manager in the Clinical Affairs department in Orthofix SRL. In her role Silvia defines and execute the clinical strategy for CE marking & FDA clearance/approval products in development, manages the preparation and update of CERs, PMCF plans and reports, and SSCPs. She is also involved in the preparation of operative techniques and Instructions For Use leaflets. Before she worked as Clinical Regulatory Lead in the Global Regulatory Compliance team in BSI where she was involved in the development of the processes for clinical evaluation and post-market requirements and in monitoring, maintaining and improving these processes. She also contributed to regulatory supervision of clinical oversight process and delivered internal training in these areas. Silvia holds a MSc in Pharmaceutical Biotechnology from University of Padua, Italy and a PhD in Cancer Biology from ETH Zurich, Switzerland.
Leon Doorn
Info Speaker

Leon Doorn

Head of Regulatory Compliance [PRRC, DPO] at Aidence
Leon is responsible for Regulatory Affairs within a scale up company, who are developing AI solutions to detect abnormalities in imaging. He is working for over 12 years in the medical industry, within the quality and regulatory field and has gained his specific knowledge on Artificial Intelligence while working at Aidence.
Stefanie Giesener
Info Speaker

Stefanie Giesener

Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, Germany
Stefanie Giesener has continuously worked for various companies in the medical device industry in the field of quality management and regulatory affairs since 1995. Since 2009, she is Head of Quality Management & Regulatory Affairs at the German IVD manufacturer DiaSys Diagnostic Systems GmbH. Beside her responsibilities in these companies, she was already engaged since 1997 in various committees in the German association of IVD manufacturers (VDGH), and in the European association (MedTech Europe) as well. In 2017 she became Member of the board at VDGH. She has already accompanied IVD manufacturers in their migration from the German Arzneimittelgesetz (AMG) to the European In vitro Diagnostic Directive (98/79/EC) and now she is responsible for the implementation of the IVDR at DiaSys.
Jan Bart Hak
Info Speaker

Jan Bart Hak

Head Medical Device Department at ProPharma Group
Jan-Bart Hak is heading the medical device department of ProPharma Group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy, vigilance and product development. Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a start-up company in biodegradable medical devices, which is currently a successful company. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.
Sarah Panten
Info Speaker

Sarah Panten

Strategic Business Development, Managing Partner at Avasis
Biography available soon
Wiebe Postma
Info Speaker

Wiebe Postma

Sr Consultant & CRO Lead at Qserve CRO
Wiebe Postma, PhD is a Sr Consultant and CRO Lead at Qserve group with close to a decade of experience in the medical device industry. A generalist with in-depth knowledge of the medical device regulations and clinical operations, his goal is to help manufacturers find practical solutions to clinical data collection and regulatory compliance. He has been involved in the setting up of pre- and post-market clinical investigations with medical devices in Europe, as well as clinical evaluation and post-market clinical follow-up planning for a broad range of devices and indications. In recent years, he had a leading role in the growth of Qserve’s CRO services.
Jasminka Roth
Info Speaker

Jasminka Roth

Founder and Director of The Tao of Excellence
Jasminka Roth is the founder and director of The Tao of Excellence. A company that provides services for strategic quality management and smart process design that is located in Switzerland - a global leader in medical technology and a hub for innovation in the industry. Jasminka is passionate about developing integrative and holistic approaches to business challenges in quality management and strategy and enabling sustainable solutions at every stage. Her leadership in quality management and business excellence for a number of high-profile companies, such as Johnson & Johnson, Novartis and a multitude of highly innovative small and midsized medical device companies has given her the specialist insight that enables her to implement creative, innovative and lasting solutions. Her long-standing experience and expertise spans healthcare, pharmaceuticals and the medical devices industry, and she is actively interested in affecting change and strengthening Switzerland’s industrial standpoint in these sectors. Jasminka holds a MSc and BSc in biochemistry and biotechnology from ETH Zürich and has carried out research at the Insel Spital in Bern and at the University of Sydney, Australia.
Danny Van Roijen
Info Speaker

Danny Van Roijen

Digital Health Director at COCIR
Biography available soon
Contatti

Laura C Collada Ali
MedDev Day Scientific Coordinator
medicalwriting@lsacademy.com
+39.320.3671224

Ilaria Butta
Events & Training Executive
ilaria.butta@lsacademy.com
+39.379.1492960


Quote di iscrizione

Full attendance | 5 sessions
€ 640,00* Early Bird fee until July 21st, 2021
€ 720,00* Ordinary fee
€ 370,00* Freelance, Academy, Public Administration

General sessions 1 and 2 + 2 sessions based from your interest
€ 580,00* Early Bird fee until July 21st, 2021
€ 650,00* Ordinary fee
€ 330,00* Freelance, Academy, Public Administration

General sessions 1 and 2 + 1 session based from your interest
€ 420,00* Early Bird fee until July 21st, 2021
€ 470,00* Ordinary fee
€ 240,00* Freelance, Academy, Public Administration

* for Italian companies: +22% VAT

Fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.
Please remind to indicate in the box “note” the session/s you would like to attend while registering.

Edizioni Passate
2020
MedDev Day 2020
2019
MedDev Day 2019
Acquista
ISCRIZIONE COMPLETA - Early Bird
Acquistabile fino al 21/07/2021
640,00
ISCRIZIONE COMPLETA – Freelance – Accademia – Pubblica Amministrazione
Acquistabile fino al 20/09/2021
370,00
SESSIONI GENERALI + 2 SESSIONI A SCELTA – Early Bird
Acquistabile fino al 21/07/2021
580,00
SESSIONI GENERALI + 2 SESSIONI A SCELTA – Freelance – Accademia – Pubblica Amministrazione
Acquistabile fino al 20/09/2021
330,00
SESSIONI GENERALI + 1 SESSIONE A SCELTA – Early Bird
Acquistabile fino al 21/07/2021
420,00
SESSIONI GENERALI + 1 SESSIONE A SCELTA – Freelance – Accademia – Pubblica Amministrazione
Acquistabile fino al 20/09/2021
240,00
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<p>Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

Virtual conference with presentations, slots for Q&A and discussion among delegates.
LS Academy will provide the link to join the conference some days before.

<p>Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>