Welcome!

News Feed Item

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 (http://www.researchandmarkets.com/research/4m4gr3/medical_device) 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

BENEFITS OF ATTENDING THIS TWO DAY PRACTICAL COURSE:

- 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.

FURTHER BENEFITS IN ATTENDING:

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

WHO SHOULD ATTEND

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

DATES:

1 & 2 April 2014

TIMES:

1 April 2014 Start: 09.30 - Finish: 17.00
2 April 2014 Start: 09.00 - Finish: 16.30

REGISTRATION & COFFEE

1 April 2014 09.00

VENUE & ACCOMMODATION

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

DIRECTIONS:

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

Speakers

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 http://www.researchandmarkets.com/research/4m4gr3/medical_device
Media Contact: Laura Wood , +353-1-481-1716, [email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Many organizations adopt DevOps to reduce cycle times and deliver software faster; some take on DevOps to drive higher quality and better end-user experience; others look to DevOps for a clearer line-of-sight to customers to drive better business impacts. In truth, these three foundations go together. In this power panel at @DevOpsSummit 21st Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, industry experts will discuss how leading organizations build application success from all...
SYS-CON Events announced today that Daiya Industry will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Daiya Industry specializes in orthotic support systems and assistive devices with pneumatic artificial muscles in order to contribute to an extended healthy life expectancy. For more information, please visit https://www.daiyak...
SYS-CON Events announced today that SIGMA Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. uLaser flow inspection device from the Japanese top share to Global Standard! Then, make the best use of data to flip to next page. For more information, visit http://www.sigma-k.co.jp/en/.
The last two years has seen discussions about cloud computing evolve from the public / private / hybrid split to the reality that most enterprises will be creating a complex, multi-cloud strategy. Companies are wary of committing all of their resources to a single cloud, and instead are choosing to spread the risk – and the benefits – of cloud computing across multiple providers and internal infrastructures, as they follow their business needs. Will this approach be successful? How large is the ...
Your clients expect transactions to never fail, cloud access to be fast and always on, and their data to be protected - no exceptions. Hear about how Secure Service Container (SSC), an IBM-exclusive open technology, enables secure building and hosting of next-generation applications, both cloud and on-premises. SSC protects the full stack from external and insider threats, allows automatic encryption of data in-flight and at-rest, and is tamper-resistant during installation and runtime – with no...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that B2Cloud will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. B2Cloud specializes in IoT devices for preventive and predictive maintenance in any kind of equipment retrieving data like Energy consumption, working time, temperature, humidity, pressure, etc.
SYS-CON Events announced today that NetApp has been named “Bronze Sponsor” of SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. NetApp is the data authority for hybrid cloud. NetApp provides a full range of hybrid cloud data services that simplify management of applications and data across cloud and on-premises environments to accelerate digital transformation. Together with their partners, NetApp em...
SYS-CON Events announced today that Interface Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Interface Corporation is a company developing, manufacturing and marketing high quality and wide variety of industrial computers and interface modules such as PCIs and PCI express. For more information, visit http://www.i...
SYS-CON Events announced today that Massive Networks, that helps your business operate seamlessly with fast, reliable, and secure internet and network solutions, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. As a premier telecommunications provider, Massive Networks is headquartered out of Louisville, Colorado. With years of experience under their belt, their team of...
SYS-CON Events announced today that Mobile Create USA will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Mobile Create USA Inc. is an MVNO-based business model that uses portable communication devices and cellular-based infrastructure in the development, sales, operation and mobile communications systems incorporating GPS capabi...
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...
SYS-CON Events announced today that N3N will exhibit at SYS-CON's @ThingsExpo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. N3N’s solutions increase the effectiveness of operations and control centers, increase the value of IoT investments, and facilitate real-time operational decision making. N3N enables operations teams with a four dimensional digital “big board” that consolidates real-time live video feeds alongside IoT sensor data a...
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
SYS-CON Events announced today that Suzuki Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Suzuki Inc. is a semiconductor-related business, including sales of consuming parts, parts repair, and maintenance for semiconductor manufacturing machines, etc. It is also a health care business providing experimental research for...