Webinar Topic
Medical Device Regulation (MDR): Challenges, Opportunities & Best Practices in Clinical Trials
Webinar Date & Time
24 May from 03:30 PM to 05:00 PM (CEST)
Webinar Overview
The MDR has been in effect for over a year now. So high time for sharing experiences and lessons learned that benefit us all as medical device researchers!
To get the most out of this event, we kick off with two key speakers with MD clinical trial conduct & independent Ethics Committee experience. They will cover key topics that challenged them most, like the increased need for clinical trials in the industry, the confusion in the field between clinical evaluations and clinical investigations, the risk of oversight of general MDR rules that also impact clinical trial management, ensuring the correct regulatory submissions per trial type, the increased and extended safety reporting needs, the increased post-market clinical follow-up requirements and related reporting requirements and timelines, the challenges you face with EUDAMED not being fully operational yet, the extension of the grace period for legacy devices, and last but not least the overlap and difference between the MDR and ISO 14155:2020 for trial conduct.
Next, a panel of four experts will discus and provide practical advice, enabling the participants to immediately understand potential challenges in the field of clinical trials upon webinar completion.
The panel discussion will be supported by real life cases from ongoing and recently conducted trials.
The webinar will be concluded with a Q&A session to give the participants the opportunity to ask all their questions, comment and/or share useful insights.
A lot to learn in a short timeframe that can have a huge positive impact on your trial conduct, outcome, budget and/or timelines, so please join our group of experts!
Learning objectives
By the end of this webinar, the participants should be able to:
- List the MDR rules that impact clinical trial conduct, including general rules, regulatory submissions, safety reporting, post-marketing requirements, and how they differ from ISO 14155:2020
- Explain the difference between clinical evaluations and clinical investigations
- List the main challenges in MD trial management
- Describe lessons learned and potential solutions to overcome these challenges
Presenters
Rianne Tooten
Owner
Rianne Tooten - Clinical Trial Services
Rianne Tooten holds a Bachelor of Science degree in Medical Biology. She currently brings more than 15 years of experience in clinical research with medical devices. From pre- till post-market studies and from medium- to high-risk medical devices.
Rianne Tooten is founder of “Rianne Tooten - Clinical Trial Services”, a training and consultancy company dedicated to support clinical research with medical devices and new medical technologies.
She is a Medical Device Expert of the Medical Research Ethics Committee of the University Medical Center in Groningen, The Netherlands. She is member of the NVFG and ACRON and has an active role in the Medical Device Working Group of the EUCROF.
It is her mission to transfer her knowledge and experience to help clinical research professionals to find practical solutions on the interpretation and implementation of the MDR and ISO14155, the GCP for clinical investigations of medical devices, by translating it into their daily practice.
Esther Daemen
Trainer at GCP Central and owner
JEA&R
Esther has 30 years global (EU, US, APAC) industry experience in biotech-pharma and medical devices, offering monitoring, project management, training, quality, compliance, inspection readiness, regulatory and GDPR services for clinical trials and businesses to assure compliance with clinical research guidelines, protocol requirements, ISO standards and applicable regulations. Experience includes monitoring, managing, performing audits and inspection readiness activities of research Institutes, Contract Research Organizations (CROs), Vendors, Consultants, Sponsors and Electronic Systems. Over 7 years EU, US and Japan industry experience in medical devices, offering strategic and operational regulatory services for attaining CE-mark and medical device FDA clearance and assisting EU authorized representatives and DPOs in their duties. Over 5 years of global (EU, US, APAC) experience, acting as certified DPO (GDPR/UK GDPR) for the healthcare industry (hospitals, sites, CROs, biotech-pharma and medical devices companies) and assisting organization in finding a trustworthy EU GDPR representative. Proficient in setting strategies and objectives aligned with business goals, developing, and managing quality, compliance, regulatory, clinical trials, and training departments, (clinical) Quality Management Systems (QMS), Learning Management Systems (LMS), GDPR/GCP and general ethical compliance, change-, conflict-, risk management and process -and system improvements. Certified in project management, synchronous learning design, data protection (GDPR) and certified Lead Auditor ISO 13485:2016. Registered nurse and master’s in business. Sought after trainer and presenter on clinical operations, GCP/ISO standards (ISO 14155:2020; 13485:2016; ISO 14971:2019; ISO 9001; ISO 19011), quality and compliance, audits and inspection readiness and regulations like EMA/FDA/MDR/CTR, vendor-, risk and process management and improvements and general leadership skills. Known for creating a quality culture and for inspiring individuals and teams across different cultures to attain a human, professional, positive, compliant, and loyal ethical code of conduct whiles executing tasks and for remediating complex or conflict situations whiles listening with patience and integrity.
Panel Participants
Mieke Tempels
Clinical Operations Manager and Quality Manager
Archer Research
After her studies in Biomedical and Pharmaceutical Sciences, Mieke started her career in clinical research in a global Pharma CRO (IQVIA) in 2010. After working as a senior CRA on international projects in various therapeutic areas, Mieke chose to broaden her knowledge and expertise and continued her career in a medical device CRO. Mieke joined Archer Research in 2015. This enabled her to use her experience to manage medical device studies efficiently for a company in start-up phase. Now, 8 years later, Mieke is currently Clinical Operations Manager and Quality Manager at Archer Research, together with an amazing team of clinical research professionals and clinical trial assistants. She is an engaged person, eager to take initiatives and responsibility to move things to the next level. Her interest in science and research and her will to make a difference in medical treatments and healthcare, brought her to her current role. Mieke is also a trainer for the ECCRT and member of the BeCRO and EUCROF Medical Device Working group.
Karen Gabriels
Clinical Research Manager
Archer Research
After finishing her master’s in biomedical sciences in Belgium, Karen Gabriëls started her career in research in The Netherlands and obtained her PhD degree at the Cardiovascular Research Institute in Maastricht in 2014. She continued her postdoctoral research in Biomedical Engineering at the University of Technology in Eindhoven. Packed with broad experience in project organization and management, she joined Archer Research in 2016 where she is currently the Clinical Research Manager. She is the regulatory and ethics expert, providing comprehensive support for medical device companies. Furthermore, she is a trainer for the ECCRT and member of the EUCROF Medical Device Workgroup.
Antoinette van Dijk
Clinical & Medical Affairs Director
D.O.Research
In 2016 she founded her own company D.O. Research, an Associate Member of EUCROF, providing consultancy in the clinical research and development for pharmaceuticals and medical devices. In the role of Clinical and Medical Affairs Director she has sound understanding of the complexity of global clinical development with a specific focus on methodological and ethical aspects of development and has more than 20 years of experience of both pharma and CRO industry and in the organisational set up of clinical trial centres. Antoinette is currently covering the role of Director Growth & Operations Europe at the Decentralised Research Organisation Care Access. She is a registered Physician. She is also a founding member of the Italian Association of CRO's, AICRO, in which she covered the role in the Board as Scientific Director for 15 years and is now still active as Chair of the Working Group Clinical Trial Centres. Through this role often involved in program committees and as speaker or chair at seminars and events. Within the European CRO Federation (EUCROF) she has been Chair of the working group for Education & Training and created the Working Group Clinical Trial Centres within EUCROF.
In March 2020 she was recognised as Global Fellow in Medicines Development, an award received from the IFAPP academy and in January 2022 she has been nominated as honorary member of the Italian Association of CRO’s (AICRO).
Şebnem Yasarogullari
VP Clinical Operations, BU Director
MENE Health Group, Chrondel SA
Şebnem Yaşaroğulları, graduated from Bogazici University Molecular Biology and Genetics. She also compleyed English teacher pedagogical formation programme at Yıldız Technical University. In 2003, Şebnem joined clinical research ecosystem in Lundbeck Pharmaceuticals to perform both the scientific and humanistic part of her profession. She continued to this exciting journey in other multinational companies like PPD CRO and Eli Lilly Pharma till 2018. During these years, she played active role in AIFD CT executive committee (research based companies pharma association) to shape the country environment to increase both research potential as well as performance. Yaşaroğulları led the MENE region on top of Turkey responsibilities and established strong clinical research teams in the region.
She had been assigned to Country Sales and Marketing Manager role for 2 years; which helped her to discover the industry from a different angle. Following this role, she became regional manager in clinical research, responsible of 24 countries in EMEA region in 2015. During all these assignments, she actively participated in several projects at local and/or global level, specifically focusing on restructuring of the business. She successfully managed those changes from brainstorming phase till execution.
Sebnem is currently working as VP Clinical Operations of MENE Health Group and laso BU Director at Chrondel SA for EMEA region.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
24 May 2023 at 6 p.m.
How to register?
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