Vigilance Planning for Device Trials Under the Revised MDD

is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Wednesday, September 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com

Manufacturers placing medical devices on the European market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS).

In the EU the medical devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.

This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.

Data Management for Medical Device Trials: Best Practices

There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation covers the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.

There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.

Data Management for Medical Device Trials: Best Practices was presented by Helen Colquhoun, MD, CEO, of Pleiad Devices and aired on 2007-11-01. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Monitoring Essentials for International Medical Device Trials

The FDA publishes warning letters on its website, and these are increasingly concerned with the monitoring of medical device clinical studies. It is clear that some device manufacturers are finding it difficult to comply with the FDA's current guidance and regulations governing the monitoring of medical device clinical trials. In Europe, monitoring standards are similar but there is often a lack of clarity of what is expected because the audience for the clinical trial application (the competent authorities) and the CE marking dossier (the notified bodies) is different.

In this presentation, Dr. Helen Colquhoun will summarize the regulations and official guidance governing the monitoring of medical device clinical trials in the USA and EU. She will also provide the audience with the essentials necessary to ensure compliance with these regulations, including giving practical examples of what monitors need to do at site. Dr. Colquhoun will also cover how to deal with difficult investigators and sites that are unwilling to comply with regulatory standards. A discussion will follow on the consequences of non-compliance, as well as how to prepare for a monitoring audit by the FDA. Dr. Colquhoun will also discuss how clinical research departments need to be resourced to deal adequately with monitoring demands. The presentation will be illustrated by real-life examples.

Monitoring Essentials for International Medical Device Trials is presented by Helen Colquhoun, MD, CEO, Pleiad Devices. For more details on this presentation, please visit our web site www.fxconferences.com

Data Management for Medical Device Trials: Best Practices

There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation will cover the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.

There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.

This audio conference is presented Helen Colquhoun, MD, CEO of Pleiad Devices. For more information of Data Management for Medical Device Trials: Best Practices, please visit our site www.fxconferences.com