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Medical Device Studies: Clinical Evidence Training Course
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Details
Course overview
Clinical evidence is crucial to bringing a device to market and is a very important aspect of post-market compliance to meet the requirements of current legislation. The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market.
This practical and intensive two-day course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices. It will cover the full range of activities that should be applied during the collection of clinical evidence for both pre- and post-market studies and will also provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies. Participants will benefit from advice and tips from industry experts on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant with the new MDR.
Benefits of attending
- Understand the regulatory requirements and guidance applicable to clinical evidence
- Clarification on Clinical Evaluations (Literature Reviews)
- Understand what is required in terms of clinical data prior to CE marking and post CE mark
- Know what documentation is needed for the pre-and post-market phases of clinical data collection
- Discover how to conduct a clinical investigation and post market clinical follow-up study
- Plan how to prepare regulatory notifications to the competent authorities and obtain other necessary approvals
- Understand the key aspects of pre and post market study setup, management, monitoring and close down
- Discuss how to prepare a paper or presentation for publication and marketing
- Understand the differences between drugs and devices
Who should attend
- Personnel involved in setting up, managing and monitoring studies
- Setting up, managing and monitoring studies
- R&D
- Marketing
- Regulatory Affair
- Those who conduct clinical evaluations/investigations/post market follow up studies
- Those moving from Pharma to Medical Device studies
Programme
The regulatory aspects of gathering clinical evidence for devices
- An overview of the regulations governing the clinical evidence aspects of devices
- How the regulations impact on clinical data for regulatory studies and post market studies
- Standards and guidelines applicable to medical device clinical evidence, ISO, GHTF (IMDRF), MEDDEV and NBMED
Conducting a pre-market clinical evaluation and the literature review
- The Clinical Evaluation (Literature Review)
- What’s involved and how it should be conducted
- What documents are required – how is clinical data used?
Example documents and templates will be provided to help delegates understand this process
Conducting a pre-market (regulatory) clinical investigation
- What types of studies and study designs are applicable to pre-market studies?
- What to consider in designing and implementing appropriate pre-market studies
Documentation for pre-market (regulatory) clinical investigation
- What documentation is needed?
- How this should be produced and what detail is required
This presentation will include template documentation for clinical investigation plans, investigator brochures, case report forms and consent forms
How to obtain the necessary approvals for pre-market studies
- How to obtain Researth Ethics approval
- How to obtain National competent authority approvals
- Other necessary approvals
- What to provide, timescales and practicalities
The differences between drugs and devices
Study management and monitoring of regulatory clinical investigation
- Key aspects study set up
- Management, monitoring and close down
- Getting the best data
How to write a final study report for a regulatory clinical investigation pre-market study
- Practical considerations for final study reports, publications and presentations of study results
Examples and templates will be provided to help delegates understand the processes - How to prepare a paper or presentation for publication and marketing
PMCF
- Practical considerations for conducting PMCF studies
- The differences between PMCF and regulatory studies
- When to conduct PMCF studies and other PMC data requirements
Current key issues affecting clinical evidence for medical devices
- The effect of changes to the directives and current initiatives throughout Europe
Presenters
Janette Benaddi (More...)
Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.
Robin Stephens (More...)
Robin Stephens is CEO & Principal Consultant, Psephos Biomedica a clinical, regulatory & quality consultancy in client-partnerships and/or interim management relationships with entrepreneurial corporations and venture-backed companies since 2001. Robin has more than 30 years experience in clinical research and regulatory affairs for medical devices throughout the world, but principally in Europe. Prior to his role with Psephos Biomedicca, Robin was the Director of QA/RA/CA for Apica Cardiovascular that is now part of the Thoratec Corporation. He was held senior roles with Conor Medsystems as well as Medtronic Vascular (previously AVE); and before that held several positions with CR Bard. Robin has been Scientific Adviser to a medical technology publishing house as well as being an author on regulatory matters and editor for a series of books on biomaterials. He holds a Masters Degree in Applied Theology from University of Wales, Bangor, a Bachelor of Science degree in Applied Chemistry from Northumbria University and is a member of the Royal Society of Chemistry.
Book now
Book now
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9-10 Nov 2020 Live webinar |
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9-10 Nov 2020 Live webinar |
GBP 1,099.00 EUR 1,579.00 USD 1,786.00 Until 28 Sep* |
Enrol now
to attend Live webinar |
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10-11 May 2021 Live webinar |
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10-11 May 2021 Live webinar |
GBP 1,099.00 EUR 1,579.00 USD 1,786.00 Until 29 Mar 21* |
Enrol now
to attend Live webinar |
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17-18 May 2021 Face-to-face, (venue not yet confirmed) |
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17-18 May 2021 Face-to-face (venue not yet confirmed) |
GBP 1,299.00 EUR 1,819.00 USD 2,026.00 Until 5 Apr 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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8-9 Nov 2021 Live webinar |
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8-9 Nov 2021 Live webinar |
GBP 1,099.00 EUR 1,579.00 USD 1,786.00 Until 27 Sep 21* |
Enrol now
to attend Live webinar |
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15-16 Nov 2021 Face-to-face, (venue not yet confirmed) |
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15-16 Nov 2021 Face-to-face (venue not yet confirmed) |
GBP 1,299.00 EUR 1,819.00 USD 2,026.00 Until 4 Oct 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
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Customised in-house training
We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.
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- Medical Device Software: Complying with the MDR & FDA Regulations
- An Essential Overview of the Medical Device Industry
- Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
- Medical Device Regulation in the Eurasian Union, Russia and the CIS
Previous customers include...
- Abiogen Pharma S.p.A.
- Air Liquide Santé International
- Allergan
- American Express Global Business Travel Espana
- Atos Medical AB
- Biogen Idec Ltd
- BSN medical GmbH / Essity
- Casen Recordati SL
- Croatian Agency for Medicinal Products and Medical Devices (HALMED)
- DePuy Synthes
- Emergo Consulting (UK) Ltd
- FIRE1
- Fisher & Paykel Health Care
- GlaxoSmithKline (GSK)
- Glycobond
- Grunenthal GmbH
- Institut Straumann AG
- Merz Pharmaceuticals GmbH
- Nobel Biocare Services AG
- Omron Healthcare Europe BV
- ORIGIO
- PAGB
- Quanta Dialysis Technologies Ltd
- SPD Development Company Limited
- SSI Diagnostica
- Terumo BCT
- Thornton & Ross Ltd
- Unomedical
- Urgo Laboratoires
- Zimmer Biomet
“A very interesting course, good for networking. Speakers were very prepared and good in enhancing discussions. ”
Barbara Acca, CRA Lead/ CTM, Cepheid, Nov 19
“I appreciated the interactive way of presenting and the incorporation of questions and examples. I learned a lot.”
Sandra Tobisch, Clinical Trial Manager, BSN medical GmbH / Essity, Nov 19
“This course was extremely helpful and relevant. The trainers were very knowledgeable and experienced. ”
Jessica Allen, Regulatory Affairs Specialist, JRI, May 19
“For me the course content was pitched well for the time allowed. I thought the presenters did a great job of managing the participants expectations.”
Stephen Rowe, Managing Director, SGR Consulting Services Ltd, Nov 18
“Overall it was a great opportunity to get more awareness on clinical studies with medical devices. The documentation provided was very clear and provided valuable input for setting procedures in my company. The speakers were very open to interaction and there was enough time for discussion. The combination with hands-on tasks was also key to understand the content.”
Ricardo De Sa, Regulatory Affairs Manager, Definiens AG, Nov 18
“Great course to give an overview of a very big topic”
Louise Corcoran, Director of Quality and Regualtory Affairs, FIRE1, Nov 18
“Great knowledge within the area of clinical studies and MDs. Interactive and willing to share their knowledge and experience. Entertaining to listen to, I never got bored despite listening for 2 days. Great!”
Anne-Christine Nilsson, COO, Glycobond, Nov 18
“I am very happy about the training, the atmosphere and the venue. Janette was great and very friendly.”
Sébastien Malaise, R&D Manager, Sinclair, May 18
“Excellent”
David Browne, Development Technician, Biovotec, May 18
“Very experienced and knowledgable [speakers]. Excellent. ”
Dawn Chesher, Regulatory Affairs Director Consumer Healthcare, GlaxoSmithKline (GSK), May 18
“I got what I needed. Theory and practical examples, Thank you!”
Karmela Kopcic, Senior Associate for Medical Devices, Croatian Agency for Medicinal Products and Medical Devices (HALMED), May 18
“Very well organised. Speaker is really experienced and knows how to teach in a friendly manner.”
Diana Villanueva, Project Manager, Precision for Medicine, May 18
“I got what I needed. Theory and practical examples, Thank you!”
Karmela Kopcic, Senior Associate for Medical Devices, Croatian Agency for Medicinal Products and Medical Devices (HALMED), May 18
“Good overall overview of clinicals ”
Julie Eyers, Regulatory Affairs Manager, Boston Scientific, Nov 17
“Open, knowledgable and clear with good detail ”
Mina Patel, RA Manager, Medtrade Products Limited, Nov 17