About

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, in-vitro diagnostics and software medical devices.

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

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
Programme

5 sessions to choose from based on your interests:

> Medical Devices Clinical Evaluation & Clinical Investigation
> Surveillance
> Regulatory Management
> In-Vitro Diagnostics
> Sofware Medical Devices

We’re working on the agenda. More details available soon

Speakers
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.
Contacts

Laura C Collada Ali
Medical Writing Consultant & Scientific Coordinator
medicalwriting@lsacademy.com
+39.320.3671224

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


Registration Fee

Registrations will open soon

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

2 general sessions + 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

2 general sessions + 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.

Past Conferences
2020
MedDev Day 2020
2019
MedDev Day 2019
Book Now

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Become Sponsor Printable Version
<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>