16.11.2020 - 17.11.2020 | Wien

CSMD 2020 - The European Conference on Clinical Studies with Medical Devices and IVDs

Veranstaltungsort: Radisson Blu Park Royal Palace Hotel, Schlossallee 8, Vienna 1140, Austria

The Conference is designed to address the most challenging and perplexing aspects of planning and conducting medical device and IVD clinical studies in accordance with the requirements of the European Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746).
 

Topics

  • Regulatory authority view of the new clinical study regulations
  • Notified Body procedures related to the evaluation of clinical investigations
  • Newly developed European guidance documents important for European clinical study conduct
  • International standards for conducting medical device and IVD studies: revised ISO 14155 and ISO 20916:2019
  • Quality system concepts in clinical study planning, management, and regulatory compliance
  • Clinical Investigation Plans that meet regulatory and operational requirements
  • Key statistical elements of a successful clinical study
  • Critical considerations in site selection and subject enrollment
  • PMCF investigations, regulatory requirements and practical considerations
  • New medical device clinical safety reporting requirements
  • Investigator-initiated studies, new requirements, new considerations
  • Effective compliance with clinical study-related European privacy requirements
  • Manufacturer best practices for working with CROs
     

Target Audience

  • Medical Professionals
  • Quality assurance individuals working in the medical device and IVD ecosystem
  • Clinical Trials Specialists
  • R&D Personnel
  • CEOs
  • Regulatory Affairs Specialists
  • CROs / CRAs
  • Clinical Research Facility Managers & Entities
  • Pharmaceutical, Biomedical and Medical Device Industries
  • Start-Up Companies


Conference Chair: 

Maria E. Donawa, MD
President, Donawa Lifescience, Italy

Weitere Informationen

Teilnahmegebühr:

Informationen zur Teilnahmegebühr erhalten Sie hier.
 

Anmeldung:

Zur Anmeldung gelangen Sie hier.
 

Weitere Informationen:

https://csmd2020.com/
 

Ansprechpartner:

Congress Secretariat
Tel UK:  +44-203-051-4032 ext. 519
Tel US:  +1-857-400-0035 ext. 519
rosemarie@bioevents-congress.com