|By PR Newswire||
|March 21, 2014 07:21 AM EDT||
DUBLIN, Mar. 21, 2014 /PRNewswire/ --
Research and Markets
) has announced the addition of the
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
Laura Wood , +353-1-481-1716, [email protected]
SOURCE Research and Markets
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 5, 2016 07:00 PM EST Reads: 146
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. 5, 2016 04:00 PM EST
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 5, 2016 04:00 PM EST Reads: 107
With microservices, SOA and distributed architectures becoming more popular, it is becoming increasingly harder to keep track of where time is spent in a distributed application when trying to diagnose performance problems. Distributed tracing systems attempt to address this problem by following application requests across service boundaries, persisting metadata along the way that provide context for fine-grained performance monitoring.
Feb. 5, 2016 03:45 PM EST Reads: 759
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 5, 2016 03:00 PM EST
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay 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. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 5, 2016 02:45 PM EST
SYS-CON Events announced today that Fusion, a leading provider of cloud services, 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. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
Feb. 5, 2016 02:30 PM EST Reads: 684
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 5, 2016 02:00 PM EST Reads: 111
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of 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, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 5, 2016 01:30 PM EST Reads: 322
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 5, 2016 01:30 PM EST Reads: 305
The maker of automated server migration software reports sales bookings increased 460 percent year-over-year and last week IDC forecast spending on public cloud services will grow to more than $141 billion in 2019. Seems (at last) we are at the tipping point where enterprises are adopting cloud in a big way opening opportunities for those who can help with the transition.
Feb. 5, 2016 01:27 PM EST
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, 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. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 5, 2016 01:15 PM EST Reads: 316
@DevOpsSummit taking place June 7-9, 2016 at Javits Center, New York City, and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Feb. 5, 2016 01:00 PM EST Reads: 487
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. 5, 2016 12:00 PM EST
SYS-CON Events announced today that VAI, a leading ERP software provider, 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. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 5, 2016 12:00 PM EST Reads: 510