|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]
SYS-CON Events announced today that FalconStor Software® Inc., a 15-year innovator of software-defined storage solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. FalconStor Software®, Inc. (NASDAQ: FALC) is a leading software-defined storage company offering a converged, hardware-agnostic, software-defined storage and data services platform. Its flagship solution FreeStor®, utilizes a horizonta...
Feb. 14, 2016 07:30 AM EST
WebSocket is effectively a persistent and fat pipe that is compatible with a standard web infrastructure; a "TCP for the Web." If you think of WebSocket in this light, there are other more hugely interesting applications of WebSocket than just simply sending data to a browser. In his session at 18th Cloud Expo, Frank Greco, Director of Technology for Kaazing Corporation, will compare other modern web connectivity methods such as HTTP/2, HTTP Streaming, Server-Sent Events and new W3C event APIs ...
Feb. 14, 2016 07:30 AM EST
Silver Spring Networks, Inc. (NYSE: SSNI) extended its Internet of Things technology platform with performance enhancements to Gen5 – its fifth generation critical infrastructure networking platform. Already delivering nearly 23 million devices on five continents as one of the leading networking providers in the market, Silver Spring announced it is doubling the maximum speed of its Gen5 network to up to 2.4 Mbps, increasing computational performance by 10x, supporting simultaneous mesh communic...
Feb. 14, 2016 05:00 AM EST
Sensors and effectors of IoT are solving problems in new ways, but small businesses have been slow to join the quantified world. They’ll need information from IoT using applications as varied as the businesses themselves. In his session at @ThingsExpo, Roger Meike, Distinguished Engineer, Director of Technology Innovation at Intuit, showed how IoT manufacturers can use open standards, public APIs and custom apps to enable the Quantified Small Business. He used a Raspberry Pi to connect sensors...
Feb. 14, 2016 04:30 AM EST Reads: 404
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Feb. 14, 2016 04:00 AM EST Reads: 263
Father business cycles and digital consumers are forcing enterprises to respond faster to customer needs and competitive demands. Successful integration of DevOps and Agile development will be key for business success in today’s digital economy. In his session at DevOps Summit, Pradeep Prabhu, Co-Founder & CEO of Cloudmunch, covered the critical practices that enterprises should consider to seamlessly integrate Agile and DevOps processes, barriers to implementing this in the enterprise, and pr...
Feb. 14, 2016 04:00 AM EST Reads: 490
Eighty percent of a data scientist’s time is spent gathering and cleaning up data, and 80% of all data is unstructured and almost never analyzed. Cognitive computing, in combination with Big Data, is changing the equation by creating data reservoirs and using natural language processing to enable analysis of unstructured data sources. This is impacting every aspect of the analytics profession from how data is mined (and by whom) to how it is delivered. This is not some futuristic vision: it's ha...
Feb. 14, 2016 03:45 AM EST Reads: 479
The principles behind DevOps are not new - for decades people have been automating system administration and decreasing the time to deploy apps and perform other management tasks. However, only recently did we see the tools and the will necessary to share the benefits and power of automation with a wider circle of people. In his session at DevOps Summit, Bernard Sanders, Chief Technology Officer at CloudBolt Software, explored the latest tools including Puppet, Chef, Docker, and CMPs needed to...
Feb. 14, 2016 03:30 AM EST Reads: 396
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
Feb. 14, 2016 02:00 AM EST Reads: 439
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, will discuss how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved effi...
Feb. 14, 2016 01:15 AM EST Reads: 298
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Feb. 13, 2016 11:15 PM EST Reads: 317
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 13, 2016 09:00 PM EST Reads: 261
Data-as-a-Service is the complete package for the transformation of raw data into meaningful data assets and the delivery of those data assets. In her session at 18th Cloud Expo, Lakshmi Randall, an industry expert, analyst and strategist, will address: What is DaaS (Data-as-a-Service)? Challenges addressed by DaaS Vendors that are enabling DaaS Architecture options for DaaS
Feb. 13, 2016 08:45 PM EST Reads: 403
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Feb. 13, 2016 08:00 PM EST Reads: 158
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 13, 2016 07:00 PM EST Reads: 425