is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 18th, 2012. For more details, or to register please visit our site at www.fxconferences.com
An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.
This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time.
Showing posts with label Frestedt Incorporated. Show all posts
Showing posts with label Frestedt Incorporated. Show all posts
Monday, April 9, 2012
Monday, February 13, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Wednesday, February 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Monday, January 9, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
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.
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.
Wednesday, August 18, 2010
The Virtual CRO: Future of Drug Development Partnerships?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Thursday, September 30th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.
But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.
The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.
But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.
Tuesday, May 11, 2010
Reducing the Impact of Risk Management on Development Budgets and Timelines
is being presented by Dr. Joy Frestedt, President & CEO, with Frestedt Incorporated and airs on Thursday, June 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Tuesday, January 12, 2010
Current FDA Thinking on Risk Evaluation and Mitigation Strategies
In September of 2009, the FDA issued a draft guidance for industry on the format and content of a proposed risk evaluation and mitigation strategy (REMS), which included REMS assessments and proposed REMS modifications. Many industry experts are working to manage the detailed requirements of this new pharmacovigilence standard to include more and tighter control over drug uses.
This session provides insight into medication guides, patient package inserts, communication plans, timelines and other elements to ensure safe use. Attendees receive helpful tips about the format and contents of REMS submissions, as well as some good practices for execution of REMS strategies.
Current FDA Thinking on Risk Evaluation and Mitigation Strategies is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Thursday, February 11, 2010. For more details or to register, please visit our site at www.fxconferences.com
This session provides insight into medication guides, patient package inserts, communication plans, timelines and other elements to ensure safe use. Attendees receive helpful tips about the format and contents of REMS submissions, as well as some good practices for execution of REMS strategies.
Current FDA Thinking on Risk Evaluation and Mitigation Strategies is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Thursday, February 11, 2010. For more details or to register, please visit our site at www.fxconferences.com
Thursday, September 17, 2009
Clinical Data Requirements under the New MDD & AIMDD
The Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) have been significantly changed by the European Amended Device Directive (2007/47/EC), and many of these changes are expected to become active in March 2010. Clinical evaluations must follow a well-defined and methodologically sound procedure. In this audio conference, the speaker describes these expectations for clinical evaluations and provides suggested templates for clinical evaluation reports (literature reviews and clinical studies).
This session provides valuable information to Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. It also provides important insights for regulatory, clinical and quality departments within device manufacturing companies, as well as to CROs and consultants who are assisting these companies with their 2010 compliance preparations.
Clinical Data Requirements under the New MDD & AIMDD is being presented by Dr. Joy Frestedt, President/CEO, of Frestedt Incorporated and airs on Wednesday, October 21, 2009. For more details, or to register please visit our site at www.fxconferences.com
This session provides valuable information to Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. It also provides important insights for regulatory, clinical and quality departments within device manufacturing companies, as well as to CROs and consultants who are assisting these companies with their 2010 compliance preparations.
Clinical Data Requirements under the New MDD & AIMDD is being presented by Dr. Joy Frestedt, President/CEO, of Frestedt Incorporated and airs on Wednesday, October 21, 2009. For more details, or to register please visit our site at www.fxconferences.com
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