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Medical Device Clinical Studies - Understand How to Conduct Pre and Post Market Medical Device Clinical Studies (Course, London)

DUBLIN, Mar. 21, 2014 /PRNewswire/ --

Research and Markets



) has announced the addition of the

"Medical Device Clinical Studies - Understand How to Conduct Pre and Post Market Medical Device Clinical Studies (Course, London)"

conference to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769)

The Medical Device Clinical Studies Course will take place on the 1st & 2nd April 2014 at the Rembrandt Hotel, London


- Understand the effect of regulatory requirements on medical device clinical studies

- Clarify what is involved in a Clinical Evaluation (Literature Review)

- Discover how to design pre market and postmarket clinical follow up studies

- Know what documentation is needed and what should go in a study master file

- Discover how to obtain Research Ethics approval in the countries of Europe

- Plan how to prepare regulatory notifications to the Competent Authorities

- Understand the key aspects of pre and post market study set up, management, monitoring and close down and the differences between medical device and medicinal product studies

- Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study

- Discuss how to prepare a paper or presentation for publication and marketing

This course has been designed specifically for those involved in conducting medical device clinical investigations and post market clinical follow-up studies. The collection of clinical data to demonstrate safety and performance of a device is pivotal to CE marking a medical device. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market.

This course will cover the full range of clinical research activities that should be applied during the collection of data for both pre and post market studies. It will provide delegates with information on the European regulations for conducting medical device studies and help them to run studies in Europe and other countries. Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe.


Participants should expect two extremely informative days with ample time for discussion, questions and case studies. Delegates will:

- Understand the role of clinical research in device development within the medical device industry

- Discover clinical trials methodology in the preparation and conduct of clinical trials of medical devices

- Take away practical knowledge on how to plan, organise and conduct clinical trials of medical devices successfully


This course will be of value to those who are involved in conducting medical device studies (clinical evaluations, clinical investigations and post market clinical follow up studies) and particularly where data may be used to support the CE marking process. Personnel involved in setting up, managing and monitoring studies will benefit from this seminar. Those involved in research and development, marketing and regulatory would enhance their understanding of device studies by attending this course. It will be of interest to professionals at all levels either new to device studies or those wishing to update and enhance their current knowledge and skills. It will be particularly useful to those moving from pharma studies to device studies.

A Certificate of Attendance for Professional Development will be given to each participant who completes the course


1 & 2 April 2014


1 April 2014 Start: 09.30 - Finish: 17.00

2 April 2014 Start: 09.00 - Finish: 16.30


1 April 2014 09.00


The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS


Opposite V&A Museum. Nearest underground station: South Kensington.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged

Key Topics Covered:

DAY ONE - 1 April 2014

Welcome, Introductions and Course Objectives

The Regulatory Framework Applicable to Medical Device Studies

- An overview of the regulations for placing medical devices on the market

- How the regulations effect device studies

- Standards and guidelines applicable to medical device studies, ISO, GHTF, MEDDEV and NBMED

Conducting a Pre Market Clinical Evaluation/Literature Review

- The Clinical Evaluation (Literature Review)

- What's involved and how it should be conducted

Example documents and templates will be provided to help delegates understand this process

Designing Pre Market and Post Market Studies

- What types of studies and study designs are applicable to pre and post market studies

- What to consider in designing and implementing appropriate pre and post market studies

Documentation for Medical Device Studies

- What documentation is needed

- How should this be produced, what should go in to a study master file

This presentation will include template documentation

DAY TWO - 2 April 2014

Ethical Considerations Throughout Europe for Pre and Post Market Studies

- How to obtain Research Ethics approval in each European Country

- What to provide, timescales and practicalities

Regulatory Clinical Investigation Notifications

- How to prepare regulatory notifications to the Competent Authorities

- What to provide, timescales and practicalities

Study Management and Monitoring

- Key aspects of pre and post market study setup

- 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

Current Key Issues Affecting Medical Device Studies

- This presentation will provide an update on the current issues affecting medical device studies, it will include the effect of changes to the directives and current initiatives throughout Europe


Janette Benaddi is Director of Clinical & Consulting Europe for NAMSA-MEDVANCE. She has 20 years experience of managing clinical studies in both devices and pharmaceuticals throughout Europe. Prior to joining NAMSA-MEDVANCE, Janette worked in Paris for a medical device consultancy group as Project Director in Clinical Affairs. She has also worked with several multi-national organisations in clinical and regulatory roles. Her knowledge and experience in medical device clinical research is vast and covers all aspects of the process. Janette is a registered nurse, has a BSc and a Diploma in Management Studies, is a Chartered Scientist and also holds a teaching certificate. She is involved with several international committees governing medical device clinical studies. She has published a number of articles related to medical device clinical investigations.

Robin Stephens is Managing Director of Psephos Biomedica Limited. Robin specialises in clinical and regulatory services to the cardiovascular medical device industry. He has more than 20 years experience in clinical research and regulatory affairs for medical devices throughout the world, but principally in Europe. Prior to establishing Psephos Biomedica, Robin was the Director of International Clinical Research & Regulatory Affairs for Medtronic Vascular (previously AVE). Before joining AVE he was Managing Director of Global Regulatory Associates Limited 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 has a BSc in Applied Chemistry/Biochemistry and is a member of the Royal Society of Chemistry.

For more information visit


Media Contact:

Laura Wood , +353-1-481-1716, [email protected]

SOURCE Research and Markets

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