We’re proud to announce that Marieke Meulemans will present “ European Clinical Trial Regulation (ECTR) and Medical Device Regulation (MDR)” on April 21st, 2021, with co-panelists Rianne Tooten and Isabelle van der Haegen. This session will be held between 13:15 and 14:00, EMT, as part of the SCRS EU Site Solutions Summit. Vivienne van der Walle will facilitate the session
What Is Changing?
Marieke and the other presenters will cover several critical upcoming changes to regulations and clinical trials within the European Union during the presentation.
The European Clinical Trials Regulation aims to create a favorable environment for clinical trials within the EU. ECTR will revolutionize and streamline the way trials are conducted and harmonize submission and assessment processes. It will also pave the way for more transparency of information and increase safety standards.
On May 26th, 2021, the new Medical Devices Regulation will come into effect, creating transparent, robust frameworks for medical devices. These new regulations will bring safety, international recognition, and access to technology.
These critical changes to the clinical trials landscape mean a different way of approaching new trials and their technology.
Presentation: What to Expect
Entitled “European Clinical Trial Regulation (ECTR) and Medical Device Regulation (MDR),” the presenters will guide you through the following:
- What is the European Clinical Trial Regulation (ECTR)
- What are the critical changes to Medical Device Regulation (MDR) on Clinical Investigations?
- How do they work?
- What is the site impact?
During the 45 minute presentation, these key learning objectives will enhance your understanding of existing regulations and further your knowledge of the new rule changes
Marieke will update you on the following:
- Identifying the critical changes in MDR and ECTR and how they differ from current knowledge.
- How your site can best prepare for the changes.
- Strategies for ensuring your site is compliant right now.
Sign up for the EU Site Summit Solutions here. [link https://eusitesolutionssummit.com/2021-registration-pricing/]
Further Your Knowledge on MDR
When ECTR launched in 2020, GCP Central was one of the first companies to introduce specialized training courses tailored for each role in clinical trials. Created for both the Dutch and the International market, this on-the-go training has proven to be popular with busy professionals.
With the Medical Device Regulation changing, your team must remain updated with the latest knowledge and changes. GCP Central has stepped up to this vital task and created a new series of courses targeting this legislation change.
Launching in September 2021, GCP Central will extend its course catalog to include a new module on this critical new piece of legislation and including ISO14155. We are developing this course with our trusted partner, Esther Daemen, CEO of JEAR BVBA in Belgium.
MDR training is critical for those wanting to sell medical devices within Europe and those involved in clinical trials. These new courses are tailored towards two essential groups:
- Clinical Researchers involved in trials with medical devices
- Sponsors involved in the setup of trails, leading to device marketing.
These comprehensive online training courses will enable your teams to understand their role in medical device research. Through our intelligent, continuous learning system, they stay up to date with the latest changes to regulations as they evolve. The training is designed to be anywhere, anytime, suiting the needs of your busy professional team.
Attend The Live Discussion At Breakout Session 2!
On the same day, Marieke will join a panel discussion about GCP Certification. This lively discussion will take place at 16:00, on April 21st.
Titled “Can I Show My Certificate Collection?” Marieke joins Suzanne Nicholl, PhD, (CCRA, Director, Customer Success Bio-Optrionics), Teresa Brodniewicz, PhD, MSc (CEO MTZ Clinical) , and Roman Fishchuk, MD, MSc (CEO Clinical Trials Unit, Central City Clinical Hospital Ivano-Frankivsk). In this lively discussion, the panel will discuss solutions for redundant site training.
With sites utilizing GCP, Vendor, eCOA and EDC technologies daily, sites are often required to complete training for these systems every 2-3 years. The panel will talk about the ways sites can show proficiencies in these technologies and replace redundant training. Sponsors may change, but vendors don’t.
Facilitated by Fiona Maini, MSc ( Prinicipal Global Compliance and Strategy, Medidata), in this session, you’ll be able to hear this panel of experts discuss the related challenges and solutions to this issue.
More About The EU Site Solutions Summit
The European Site Solutions Summit is held annually, providing sites, sponsors, and CROs the opportunity to share the latest knowledge, trends, and best practices in the EU. Register now to access the sessions featuring Marieke, as well as other valuable insights from other industry leaders.