The Impact of the new MDR on Clinical Research

Description
Regulatory

The Medical Device Regulation (EU 2017/745) has been published and will replace the Medical Device Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union. The MDR describes the need for clinical evaluation and post-market clinical follow-up.
This 2-hour recorded session will focus on the impact of the new MDR on clinical investigations and our daily work in clinical research.

At the end, you will receive a certificate and the course hand-outs.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Summarize the applicable regulatory framework for medical devices in the EU.
  • Identify the key changes to the requirements related to clinical investigations today
Intended audience

Skilled Level
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”