Friday special - save 75% on "GCP for Medical Device Trials: Upcoming Revisions to ISO 14155"

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.

This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.

But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits was presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad Inc. and aired on 2008-10-09. For more details or to download this conference, please visit our site at www.fxconferences.com

Taking the Literature Route for Clinical Evaluations

Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, a clinical trial or a combination of the two.

This audio conference focuses on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation highlights pitfalls and best practices, and describe Medical Device Directive (MDD) requirements concerning clinical evaluations. This presentation also discusses use of the clinical literature review as a tool for post-market surveillance and as an input into risk management processes.

Taking the Literature Route for Clinical Evaluations was presented by Carol Houts, Director of Regulatory, Quality and Safety Concerns, with Pleiad and aired on 2008-07-24. This audio conference is available for download at www.fxconferences.com

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision. This audio conference will focus on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation will review the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants will also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker will also provide attendees with an essential clinical investigation document checklist.

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 is being presented by Carol Houts, Director of Regulatory, Quality & Safety, with Pleiad, Inc. and airs on Thursday, February 26th, 2009. For more details or to register please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - part 1 and 2) is currently under revision. This audio conference will focus on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. The presentation will review the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants will also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Part 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker will also provide attendees with an essential clinical investigation document checklist.

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 is being presented by Carol Houts, Director of Regulatory, Quality & Safety, with Pleiad, Inc. and airs on Thursday, February 26th, 2009. For more details or to register please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one credit toward a participant's RAC recertification upon completion.

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits is presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad on Thursday, Oct. 9, 2008. For more details or to register. please visit our site www.fxconferences.com