Introduzione

As the European medical devices regulations (MDR) enters its third year of application, the industry is striving to comply with MDR compliance in a challenging economic and regulatory environment.

As first movers approach their recertification dates, other companies are achieving their initial product and quality system certifications, while some industry players are still in the application phase to meet the transitional requirements.

At the same time, the regulatory system is scrutinised to see how it delivers on its promises of better regulation, less burdensome requirements, and competitiveness and attractiveness in a global perspective.

This year’s MedDev Day will focus on the attractiveness of the European regulatory landscape for medical devices, improvements made and future developments.

Delegates will get practical insights on:

  • how to meet MDR requirements and cost of compliance,
  • the comparison of the European system to other regulatory regimes and global regulatory and clinical strategy
  • how to streamline and cost effectively meet post market obligations
  • how to achieve recertifications in a least burdensome approach
  • how to minimize efforts for phasing out MDD/AIMDD and how to successfully shift to MDR as for transition delegates
  • latest developments on the regulation, EUDAMED and clinical standards

The one-and-a-half-day program features Industry and competent authority talks followed by interactive workshops to allow elaborate solutions for post market programs and clinical strategy.

Scientific Board:

Bassil Akra, Chief Executive Officer at AKRA TEAM
Arkan Zwick, Corporate Regulatory Affairs Director at CROMA Pharmaceutical


Who should attend?

The conference is aimed at medical device professionals from Regulatory Affairs, Quality, Clinical Operations, Medical Affairs, Post Marketing Surveillance departments working in Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organisations, Competent Authorities, EU Commission and Regulatory Authorities.

Programma

It will be one day and a half, starting on the 7th of October in the afternoon.
Programme work in progress

Relatori
Bassil Akra
Info Scientific Board

Bassil Akra

Chief Executive Officer at AKRA TEAM GmbH
Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.
Arkan Zwick
Info Scientific Board

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical
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.
Contatti

Valeria Quintily
Sr. Scientific Project Manager
valeria.quintily@lsacademy.com

Ilaria Butta
Events and Training Manager
ilaria.butta@lsacademy.com


Quote di iscrizione

€ 670,00 Early Bird fee until 09 September 2024
€ 790,00 Ordinary fee
€ 430,00 Freelance, Individual, Academy, Public Administration

Fee includes: seat at the conference, pdf copy of presentations of Speakers who allow the distribution, networking lunch, coffee breaks, organisational office assistance, certificate of attendance.


Informazioni utili

The conference will take place at:

Hotel Scandic Copenhagen
Vester Søgade 6, Copenhagen – Denmark

Centrally located, 500 metres from Copenhagen Central Station, this contemporary hotel offers stunning views of the lakes and the Copenhagen skyline. From Copenhagen Airport: only 12 km by car. By public transport (via metro or bus), journey time around 25-minutes.

Edizioni Passate
2023
Attractiveness of the EU market with the MDR. Where the Regulation stands - what is next?
2022
MDR 2017/745 Reality Check – Readiness of the EU System
2021
MedDev Day 2021
2020
MedDev Day 2020
2019
MedDev Day 2019
Registrati
Early bird
Acquistabile fino al 09/09/2024
670,00
Ordinaria
Acquistabile fino al 06/10/2024
790,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 06/10/2024
430,00
Svuota

Versione Stampabile
Contattaci per ricevere maggiori informazioni sulle opportunità di sponsorizzazione
Diventa Sponsor
<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>

Hotel Scandic Copenhagen
Vester Søgade 6
Copenhagen – Denmark

<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>
<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>
<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>