|By PR Newswire||
|March 21, 2014 07:22 AM EDT||
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.
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
1 & 2 April 2014
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
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 http://www.researchandmarkets.com/research/4m4gr3/medical_device
Media Contact: Laura Wood , +353-1-481-1716, [email protected]
“This win means a great deal to us because it is decided by the readers – the people who understand how use of our technology enables new insights that drive the business,” said Matt Davies, senior director, EMEA marketing, Splunk. “Splunk Enterprise enables organizations to improve service levels, reduce operations costs, mitigate security risks, enhance DevOps collaboration, create new product and service offerings and obtain deeper insight into customer behavior. Being named Best Business App...
Jan. 25, 2015 10:30 PM EST Reads: 1,743
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, ...
Jan. 25, 2015 07:45 PM EST Reads: 2,296
The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
Jan. 25, 2015 07:00 PM EST Reads: 2,326
SYS-CON Media announced that Cisco, a worldwide leader in IT that helps companies seize the opportunities of tomorrow, has launched a new ad campaign in Cloud Computing Journal. The ad campaign, a webcast titled 'Is Your Data Center Ready for the Application Economy?', focuses on the latest data center networking technologies, including SDN or ACI, and how customers are using SDN and ACI in their organizations to achieve business agility. The Cisco webcast is available on-demand.
Jan. 25, 2015 07:00 PM EST Reads: 1,201
Datapipe has acquired GoGrid, a provider of multi-cloud solutions for Big Data deployments. GoGrid’s proprietary orchestration and automation technologies provide 1-Button deployment for Big Data solutions that speed creation and results of new cloud projects. “GoGrid has made it easy for companies to stand up Big Data solutions quickly,” said Robb Allen, CEO, Datapipe. “Datapipe customers will achieve significant value from the speed at which we can now create new Big Data projects in the clou...
Jan. 25, 2015 06:30 PM EST Reads: 1,562
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what th...
Jan. 25, 2015 06:15 PM EST Reads: 3,781
The Internet of Things (IoT) is rapidly in the process of breaking from its heretofore relatively obscure enterprise applications (such as plant floor control and supply chain management) and going mainstream into the consumer space. More and more creative folks are interconnecting everyday products such as household items, mobile devices, appliances and cars, and unleashing new and imaginative scenarios. We are seeing a lot of excitement around applications in home automation, personal fitness,...
Jan. 25, 2015 06:00 PM EST Reads: 2,701
Security can create serious friction for DevOps processes. We've come up with an approach to alleviate the friction and provide security value to DevOps teams. In her session at DevOps Summit, Shannon Lietz, Senior Manager of DevSecOps at Intuit, will discuss how DevSecOps got started and how it has evolved. Shannon Lietz has over two decades of experience pursuing next generation security solutions. She is currently the DevSecOps Leader for Intuit where she is responsible for setting and driv...
Jan. 25, 2015 06:00 PM EST Reads: 1,396
Dale Kim is the Director of Industry Solutions at MapR. His background includes a variety of technical and management roles at information technology companies. While his experience includes work with relational databases, much of his career pertains to non-relational data in the areas of search, content management, and NoSQL, and includes senior roles in technical marketing, sales engineering, and support engineering. Dale holds an MBA from Santa Clara University, and a BA in Computer Science f...
Jan. 25, 2015 06:00 PM EST Reads: 2,975
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., showed what is needed to leverage the IoT to transform your business. ...
Jan. 25, 2015 04:30 PM EST Reads: 3,011
SYS-CON Media announced today that PagerDuty has launched a popular blog feed on DevOps Journal. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done.
Jan. 25, 2015 04:00 PM EST Reads: 1,336
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP ...
Jan. 25, 2015 04:00 PM EST Reads: 2,419
SYS-CON Events announced today that CodeFutures, a leading supplier of database performance tools, has been named a “Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. CodeFutures is an independent software vendor focused on providing tools that deliver database performance tools that increase productivity during database development and increase database performance and scalability during production.
Jan. 25, 2015 04:00 PM EST Reads: 1,539
Cloud Technology Partners on Wednesday announced it has been recognized by the Modern Infrastructure Impact Awards as one of the Best Amazon Web Services (AWS) Consulting Partners. Selected by the editors of TechTarget's SearchDataCenter.com, and by votes from customers and strategic channel partners, the companies acknowledged by the Modern Infrastructure Impact Awards represent the top providers of cloud consulting services for AWS including application migration, application development, inf...
Jan. 25, 2015 03:00 PM EST Reads: 1,198
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
Jan. 25, 2015 03:00 PM EST Reads: 2,426