DUBLIN, Oct. 29, 2019 /PRNewswire/ -- The "Medical Device Studies: Clinical Evidence" conference has been added to ResearchAndMarkets.com's offering.

Clinical evidence is key to bringing a device to market and is a very important aspect of post-market evidence gathering to meet the 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 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 and help them to run studies in Europe and other countries. Delegates will benefit from the advice and tips 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
• R&D
• Marketing
• Regulatory Affair
• Those who conduct clinical evaluations/investigations/post market follow up studies
• Those moving from Pharma to Medical Device studies

Agenda:

Programme day one

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

Programme day two

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

Post-market clinical follow-up studies

• Practical considerations for conducting post market clinical follow up studies
• The differences between PMCFU and regulatory studies
• When to conduct PMCFU 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

For more information about this conference visit https://www.researchandmarkets.com/r/tsd51o

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SOURCE Research and Markets

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