is being presented by Janette Benaddi, CEO, of Medvance and airs on Tuesday, March 6th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.
This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.
Showing posts with label Medvance. Show all posts
Showing posts with label Medvance. Show all posts
Monday, February 20, 2012
Tuesday, November 1, 2011
Conducting Clinical Evaluations to Support Regulatory Approval and Marketing of Medical Devices
is being presented by Janette Benaddi, CEO, of Medvance and airs on Wednesday, November 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com
With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.
This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.
With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.
This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.
Tuesday, August 16, 2011
Conducting Medical Device Studies Under the Revised ISO 14155
is being presented by Janette Benaddi, CEO, with Medvance and airs on Tuesday, September 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.
In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.
The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.
In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.
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