|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]
“delaPlex Software provides software outsourcing services. We have a hybrid model where we have onshore developers and project managers that we can place anywhere in the U.S. or in Europe,” explained Manish Sachdeva, CEO at delaPlex Software, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 26, 2016 12:00 AM EDT Reads: 1,537
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Jul. 26, 2016 12:00 AM EDT Reads: 2,135
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Jul. 25, 2016 11:15 PM EDT Reads: 2,011
"We've discovered that after shows 80% if leads that people get, 80% of the conversations end up on the show floor, meaning people forget about it, people forget who they talk to, people forget that there are actual business opportunities to be had here so we try to help out and keep the conversations going," explained Jeff Mesnik, Founder and President of ContentMX, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 25, 2016 11:15 PM EDT Reads: 1,307
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Jul. 25, 2016 11:00 PM EDT Reads: 1,023
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 25, 2016 11:00 PM EDT Reads: 1,512
"When you think about the data center today, there's constant evolution, The evolution of the data center and the needs of the consumer of technology change, and they change constantly," stated Matt Kalmenson, VP of Sales, Service and Cloud Providers at Veeam Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 25, 2016 10:45 PM EDT Reads: 1,299
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
Jul. 25, 2016 10:15 PM EDT Reads: 1,677
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products. But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast. Download our guide to laying the groundwork for a scalable continuous testing strategy.
Jul. 25, 2016 10:15 PM EDT Reads: 1,920
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, discussed 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 efficienc...
Jul. 25, 2016 10:00 PM EDT Reads: 1,941
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jul. 25, 2016 10:00 PM EDT Reads: 2,501
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Jul. 25, 2016 08:30 PM EDT Reads: 1,934
StackIQ has announced the release of Stacki 3.2. Stacki is an easy-to-use Linux server provisioning tool. Stacki 3.2 delivers new capabilities that simplify the automation and integration of site-specific requirements. StackIQ is the commercial entity behind this open source bare metal provisioning tool. Since the release of Stacki in June of 2015, the Stacki core team has been focused on making the Community Edition meet the needs of members of the community, adding features and value, while ...
Jul. 25, 2016 08:15 PM EDT Reads: 240
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...
Jul. 25, 2016 08:00 PM EDT Reads: 1,916
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
Jul. 25, 2016 08:00 PM EDT Reads: 1,972