WHY SHOULD I JOIN THE WORKSHOP
The workshop “MDR MASTER CLASS” blends Academy and Industry to offer the most modern education for Medtech and Clinical Professionals. It is designed to discover the steps for a winning transition to the new Medical Device Regulation.
The program includes exclusive content developed by Meditrial experts and is suitable for professional at any level of kwonledge (beginner to advanced professional).
Lectures allow a direct interaction with the Keynote Speaker who is an academic clinician personally involved in developing the new regulation and has hands-on experience of challenges for startups and large corportations.
Participants are exposed to a combination of trainings for regulatory and clinical skills. Learning is delived trough a dedicated portal, Meditrial Academy, where the participant can access the lecture slides, a variety of recommended readings, and take a final exam to obtain a course certification.
TOPICS
Explore the new Medical Device Regulation (MDR) 745/2017 and learn the phylosophy of the new European System based on centralized information and much closer now to the rules already enforced by the US FDA. You will understand the key changes in the transition from the MDD to the new MDR. The knowledge gained will allow you to asses the impact for your organization and the appropriate next steps to meet the new requirements.
Learn how to run clinical trials under the new Medical Device Regulation (MDR) 745/2017. Get ready for the evolutions that will enhance your trials and increase your success. Discover the key changes of ISO 14155:2019 – GCP for medical devices – from Dr. Tocchi who is one of the international experts that developed this new standard. Get ready for applying the new concepts for clinical trial design and conduct, risk management, data capture and safety assessments.
WHO SHOULD PARTICIPATE?
Members of the Medtech Industry and Clinical Research Community who want to quickly gain a complete skillset to be successful in the new MDR era.
The course is ideal for
– Clinical and Biomedical Engineers
– Manufacturers of Medical Devices
– Medical devices designers
– Regulatory affairs specialists
– Quality system specialists
– Clinical project managers
– Clinical trial monitors
EVENT SCHEDULE
- 09:00 Registration for Workshop MDR MASTER CLASS
- 09:15 MDR Overview and implementation timelines, EUDAMED 101, UDI tips and tricks, new approaches for labeling and IFU
- 11:00 Coffee break
- 11:15 Postmarket program: how to steramline surveillance, PMCF, Vigilance. Select and manage the economic operators for market success
- 13:00 lunch Brake
- 14:00 MDR for Clinical Trials. New MDR Rules for Clinical Investigations. What, when and how to get ready
- 15:45 Coffee break
- 16:00 New ISO 14155:2019, key changes and how they affect your trials
- 17:00 F2F meetings
EVENT KEY NOTE SPEAKER
Dr. Monica Tocchi
Meditrial Medical Director | Medical Device Expert
Dr. Monica Tocchi is a physician with a specialization in cardiology and PhD in cardiovascular pathophysiology, author of multiple groundbreaking research publications. She is medical director of Meditrial, a CRO that manages clinical trials and market approvals for some of the most innovative devices in the world. As CEO of a medical device startup company, she understands the needs and challenges of innovators.
Dr Tocchi is an expert on European and U.S. regulations and works with the ISO (lnternational Standardization Organization) and AAMI (Association for the Advancement of Medical Instrumentation) committees to develop new regulations on clinical trials (ISO 14155) cardiac valves (ISO 5840, ISO 5910) and other medical device standards.
COURSE MATERIAL
- Personal Access to Meditrial
- Academy Online Training Portal
- Guidelines and Training Materials
- Meditrial MDR Pocketbook
- Meditrial Academy App
- Final Online Exam
- Meditrial Academy Certificate
A certificate of attendance for professional development will be given to each participant who completes the workshop.
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