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 The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring.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 Helen Colquhoun. Show all posts
Showing posts with label Helen Colquhoun. 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, 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
Tuesday, October 20, 2009
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 also addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
Medical Device Clinical Evaluations: EU vs. US was presented by Helen Colquhoun, MD, CEO, with Pleiad Devices. For more details, or to download this event please visit our site at www.fxconferences.com
To learn more about German Translations, please visit ForeignExchange Translations website at www.fxtrans.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 also addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
Medical Device Clinical Evaluations: EU vs. US was presented by Helen Colquhoun, MD, CEO, with Pleiad Devices. For more details, or to download this event please visit our site at www.fxconferences.com
To learn more about German Translations, please visit ForeignExchange Translations website at www.fxtrans.com
Friday, August 28, 2009
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
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
Wednesday, August 12, 2009
Medical Device Vigilance in the EU: Reporting Requirements & Event Trending
The revised MEDDEV 2.12-1 Rev 5 guidance regarding medical device vigilance was issued in April 2007, and came into effect on January 1, 2008. Whilst not legally binding, this guidance does reflect EU competent authority expectations, and companies are advised to build their vigilance system around the guidance, which needs to be fully understood. For example, 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). Examination of the patient reveals movement in the joint, demonstrating lack of fusion. Is this a reportable event?
In this session the speaker reviews the guidance, explains some key definitions and responsibilities, provides a vigilance process map and examines the criteria for reporting, using several examples. Event trending is also discussed, and how to make sense of the information that is delivered via the vigilance system.
Medical Device Vigilance in the EU: Reporting Requirements & Event Trending is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Tuesday, September 22, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
In this session the speaker reviews the guidance, explains some key definitions and responsibilities, provides a vigilance process map and examines the criteria for reporting, using several examples. Event trending is also discussed, and how to make sense of the information that is delivered via the vigilance system.
Medical Device Vigilance in the EU: Reporting Requirements & Event Trending is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Tuesday, September 22, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
Wednesday, June 10, 2009
Medical Device Vigilance: An Input to Risk Management
Risk management is the process by which medical device manufacturers ensure that their devices are used with the minimum of risk. The risk management process involves assessing all theoretical, potential and actual risks for a product (the inputs), assessing the impact of those risks on the user of the device, and putting in place strategies to mitigate those risks (the outputs). Early in the device development process, most of the risks are theoretical. However, as the device moves into clinical use, safety data are generated and real risks are identified or confirmed.
This audio conference presents information about how vigilance (the collection and appraisal of human safety information), supplemented by non-clinical and bench data, feeds into the risk management process, and how the outputs are managed. This sounds like a fairly simple process, but interpreting vigilance data is not always easy. There may be internal corporate resistance to ideal modes of risk mitigation, and it is difficult to deal with risks that arise from misuse of the device. All of these issues are dealt with and illustrated by case studies presented in the audio conference.
Medical Device Vigilance: An Input to Risk Management is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Thursday, July 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
This audio conference presents information about how vigilance (the collection and appraisal of human safety information), supplemented by non-clinical and bench data, feeds into the risk management process, and how the outputs are managed. This sounds like a fairly simple process, but interpreting vigilance data is not always easy. There may be internal corporate resistance to ideal modes of risk mitigation, and it is difficult to deal with risks that arise from misuse of the device. All of these issues are dealt with and illustrated by case studies presented in the audio conference.
Medical Device Vigilance: An Input to Risk Management is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Thursday, July 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
Wednesday, October 15, 2008
The Revised MDD: Practical Implications for Devices
The Medical Devices Directive (MDD), which sets down the rules and regulations for marketing medical devices in the EU, is in the final stages of a lengthy revision process. The general consensus is that the directive has been working well to date, but that certain aspects need to be tightened up. To this end, there are no radically new requirements, but there will be an increased demand for clinical data and post-market surveillance. What will this mean for medical device manufacturers?
In this audio conference, Dr. Helen Colquhoun summarizes the revisions and describe in detail those with the greatest potential impact. She discusses the implications of these revisions for medical device manufacturers, illustrating points with practical examples and using different scenarios to explain how best to approach the issues raised.
The Revised MDD: Practical Implications for Devices was recorded on 2006-02-23 and is available for download at www.fxconferences.com
In this audio conference, Dr. Helen Colquhoun summarizes the revisions and describe in detail those with the greatest potential impact. She discusses the implications of these revisions for medical device manufacturers, illustrating points with practical examples and using different scenarios to explain how best to approach the issues raised.
The Revised MDD: Practical Implications for Devices was recorded on 2006-02-23 and is available for download at www.fxconferences.com
Wednesday, September 10, 2008
Industry Update: Revisions to the Medical Devices Directive
Due to the widely held view that certain aspects needed to be clarified, the EU Medical Devices Directive (MDD) is being revised. A number of proposed revisions have been under consideration for over a year now. Among the likely changes, there will be an increased demand for clinical data and post-market surveillance.
In this audio conference, Dr. Helen Colquhoun provides an update on the review progress, and describe the revisions, giving detail on those of greatest importance to device companies.
Industry Update: Revisions to the Medical Devices Directive was recorded on 2007-02-22 and is now available for download at www.fxconferences.com
In this audio conference, Dr. Helen Colquhoun provides an update on the review progress, and describe the revisions, giving detail on those of greatest importance to device companies.
Industry Update: Revisions to the Medical Devices Directive was recorded on 2007-02-22 and is now available for download at 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.
Friday, August 1, 2008
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
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
Subscribe to:
Posts (Atom)