is being presented by Cheryl Hill, Regulatory Manager, with Pleiad Inc. and airs on Wednesday, May 2nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Showing posts with label Pleiad. Show all posts
Showing posts with label Pleiad. Show all posts
Tuesday, April 24, 2012
Wednesday, March 14, 2012
Monitoring Essentials for Medical Device Trials
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 The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring.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.
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.
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, October 4, 2011
Best Practices for Conducting Ophthalmology Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, November 2nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There are many challenges facing those who design, set up, and monitor ophthalmology trials. The first is deciding whether to study one eye or both eyes, and to understand the statistical implications of that choice. The next challenge is to understand the many assessments, measurements, and endpoints utilized in ophthalmology trials, and how to standardize their collection over many sites. Finally, monitors need to understand the data they are monitoring, in order to identify adverse trends and improbable values, thereby improving data quality.
In this audio conference, our speaker reviews the common and some not-so-common ophthalmic tests used as outcome measures in clinical trials, giving pointers for monitoring best practices in ophthalmology, and discussing site certification and standardization. The presentation also describes the statistical and study design issues, so that attendees understand how they will impact their decisions about study design and analysis.
There are many challenges facing those who design, set up, and monitor ophthalmology trials. The first is deciding whether to study one eye or both eyes, and to understand the statistical implications of that choice. The next challenge is to understand the many assessments, measurements, and endpoints utilized in ophthalmology trials, and how to standardize their collection over many sites. Finally, monitors need to understand the data they are monitoring, in order to identify adverse trends and improbable values, thereby improving data quality.
In this audio conference, our speaker reviews the common and some not-so-common ophthalmic tests used as outcome measures in clinical trials, giving pointers for monitoring best practices in ophthalmology, and discussing site certification and standardization. The presentation also describes the statistical and study design issues, so that attendees understand how they will impact their decisions about study design and analysis.
Thursday, August 18, 2011
In-Vitro Diagnostics: Testing Times
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
Wednesday, June 29, 2011
Usability and Clinical Testing for Home-use Medical Devices
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, August 3rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.
In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.
This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.
There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.
In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.
This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.
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.
Friday, April 1, 2011
MEDDEV 2.7/3: Best Practices for Clinical Evaluation Reports
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, May 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of 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, clinical trials, or a combination of the two.
This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.
Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of 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, clinical trials, or a combination of the two.
This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.
Tuesday, February 8, 2011
Safety Reporting for Clinical Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, March 9th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
Friday, December 10, 2010
Medical Device Vigilance - Reporting Requirements in the EU
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, January 12th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The revised MEDDEV 2.12-1 Rev 6 guidance about medical device vigilance came into effect in December of 2009. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
The revised MEDDEV 2.12-1 Rev 6 guidance about medical device vigilance came into effect in December of 2009. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
Monday, September 20, 2010
Medical Device Vigilance - Reporting Requirements in the EU
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, October 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The revised MEDDEV 2.12-1 Rev 5 guidance about medical device vigilance came into effect on January 1, 2008. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
The revised MEDDEV 2.12-1 Rev 5 guidance about medical device vigilance came into effect on January 1, 2008. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
Friday, May 7, 2010
Running Home-based Clinical Trials for Medical Devices and Diagnostics
is being presented by Helen Colquhoun, CEO, of Pleiad Inc and airs on Tuesday, June 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA recently (20 April 2010) issued a news release about formulating guidance about the challenges of using complex medical devices in the home. There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate home-use because payers will not pay for and patients will not attend prolonged hospital or clinic-based treatment regimens. There is good evidence from patients with renal failure on dialysis that more frequent, short-duration treatment sessions improve clinical outcomes and that may be true of many therapies delivered by complex devices.
In order to obtain labelling that allows use of a complex device or a diagnostic in the home, clinical data need to be obtained that demonstrate that patients of different ages, with different education and professional backgrounds, and different physical abilities (the so-called human factors), can all use the device or diagnostic successfully in the intended setting (the home). Setting up and managing clinical trials in patients' homes is very challenging but not impossible. In this audio conference, Dr. Helen Colquhoun describes these challenges and how best to meet them, using liberal examples.
The FDA recently (20 April 2010) issued a news release about formulating guidance about the challenges of using complex medical devices in the home. There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate home-use because payers will not pay for and patients will not attend prolonged hospital or clinic-based treatment regimens. There is good evidence from patients with renal failure on dialysis that more frequent, short-duration treatment sessions improve clinical outcomes and that may be true of many therapies delivered by complex devices.
In order to obtain labelling that allows use of a complex device or a diagnostic in the home, clinical data need to be obtained that demonstrate that patients of different ages, with different education and professional backgrounds, and different physical abilities (the so-called human factors), can all use the device or diagnostic successfully in the intended setting (the home). Setting up and managing clinical trials in patients' homes is very challenging but not impossible. In this audio conference, Dr. Helen Colquhoun describes these challenges and how best to meet them, using liberal examples.
Thursday, January 28, 2010
Electronic vs. Paper Data Capture: Which Option is Best for Your Trial?
There are many factors that come into play when deciding whether to employ electronic or paper data capture (EDC or PDC) for data management of a clinical trial. Most people focus on the perceived benefits of EDC, mainly relating to the ability to look at data on an ongoing basis. But there are other aspects that require consideration, such as set-up time, cost, and whether there are patient-generated data. These considerations are particularly important for small companies who run few trials, and therefore do not have in-house data management capabilities.
This presentation covers all aspects of EDC vs. PDC, describing the pros and cons of each for different situations. For example, what is the most cost-effective solution for a medical device company that runs one trial a year on average, has no in-house data management capability, and whose trials involve few patients, long follow-up periods, and patient-generated data? Conversely, what is the best solution for an in-vitro diagnostics company that performs large studies of several thousand patients with a very small case report form, almost no follow-up period, and the requirement to import large amounts of laboratory data?
Electronic vs. Paper Data Capture: Which Option is Best for Your Trial? is being presented by Helen Colquhoun, CEO, with Pleiad Inc. and airs on Wednesday, February 24, 2010. For more details or to register, please visit our site at www.fxconferences.com
This presentation covers all aspects of EDC vs. PDC, describing the pros and cons of each for different situations. For example, what is the most cost-effective solution for a medical device company that runs one trial a year on average, has no in-house data management capability, and whose trials involve few patients, long follow-up periods, and patient-generated data? Conversely, what is the best solution for an in-vitro diagnostics company that performs large studies of several thousand patients with a very small case report form, almost no follow-up period, and the requirement to import large amounts of laboratory data?
Electronic vs. Paper Data Capture: Which Option is Best for Your Trial? is being presented by Helen Colquhoun, CEO, with Pleiad Inc. and airs on Wednesday, February 24, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
Tuesday, September 1, 2009
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
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
Monday, March 30, 2009
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
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
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.
Thursday, September 18, 2008
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
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
Wednesday, August 20, 2008
Medical Device Clinical Evaluations: EU vs. US
In this presentation, Dr. Colquhoun explains the circumstances in which medical device manufacturers need to generate de novo clinical data. The audio conference also looks at the different types of clinical evaluations and the importance of conducting them in the EU (and USA).
The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.
The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.
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