is being presented by Helen Colquhoun, CEO, Pleiad Inc. and airs on Wednesday, March 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Showing posts with label ISO 14155. Show all posts
Showing posts with label ISO 14155. Show all posts
Wednesday, March 14, 2012
Friday, January 13, 2012
Preparing for 2012: Regulatory Update for Device & Diagnostic Companies
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, January 31st, 2012. For more details, or to register please visit our site at www.fxconferences.com
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
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.
Friday, July 8, 2011
Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, August 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Thursday, May 5, 2011
The 2011 ISO 14155 Revision: Keeping SOPs Up-to-Date
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, June 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The ISO 14155 standard for the conduct of clinical trials -- published in 2003 and updated in 2009 -- was revised again in 2011. However, some companies still haven't updated their standard operating procedures (SOPs) to reflect the 2009 revision, and lack the internal processes to ensure that SOPs are always updated in concert with new or revised regulations and guidance.
This audio conference presentation outlines a process by which companies can keep up-to-date with changes in regulations and guidance, and make sure their SOPs and working practice documents (WPDs) are in compliance with the latest regulatory requirements and guidance.
Our speaker uses the latest ISO 14155 guidance update as an example, to show how a robust process for regulatory intelligence gathering and SOP review can keep you on top of the latest standards. The presentation reviews the important changes in this latest version of the ISO 14155 guidance, and draws upon recent real-life client experience to look at how these can be incorporated into revisions to SOPs and WPDs.
The ISO 14155 standard for the conduct of clinical trials -- published in 2003 and updated in 2009 -- was revised again in 2011. However, some companies still haven't updated their standard operating procedures (SOPs) to reflect the 2009 revision, and lack the internal processes to ensure that SOPs are always updated in concert with new or revised regulations and guidance.
This audio conference presentation outlines a process by which companies can keep up-to-date with changes in regulations and guidance, and make sure their SOPs and working practice documents (WPDs) are in compliance with the latest regulatory requirements and guidance.
Our speaker uses the latest ISO 14155 guidance update as an example, to show how a robust process for regulatory intelligence gathering and SOP review can keep you on top of the latest standards. The presentation reviews the important changes in this latest version of the ISO 14155 guidance, and draws upon recent real-life client experience to look at how these can be incorporated into revisions to SOPs and WPDs.
Wednesday, March 16, 2011
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Monday, December 13, 2010
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 19th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Friday, November 6, 2009
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.
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.
Thursday, September 10, 2009
Preparing for Increased European Clinical Data and Evaluation Requirements
The newly revised European Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) come into effect on March 21, 2010. There is no transition period, which means that medical devices placed on the market or put into service as of that date will be expected to comply with the revised directives. Some of the most important revisions concern clinical data and clinical evaluation, and the types of adverse events that must be reported if they occur during the clinical study.
In this audio conference, the speaker reviews these changes to the directives, their relationship to ISO 14155, and explores effective ways to prepare for compliance.
Preparing for Increased European Clinical Data and Evaluation Requirements is being presented by Dr. Maria Donawa, President, of Donawa Lifescience Consulting and airs on Thursday, October 8, 2009. For more details, or to register for this audio conference, please visit our site at www.fxconferences.com
In this audio conference, the speaker reviews these changes to the directives, their relationship to ISO 14155, and explores effective ways to prepare for compliance.
Preparing for Increased European Clinical Data and Evaluation Requirements is being presented by Dr. Maria Donawa, President, of Donawa Lifescience Consulting and airs on Thursday, October 8, 2009. For more details, or to register for this audio conference, please visit our site at www.fxconferences.com
Monday, January 19, 2009
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.
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.
Thursday, January 15, 2009
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.
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.
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