is being presented by Elisabethann Wright, Hogan Lovells International LLP and airs on Tuesday, December 6th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The Internet provides an ever-growing source of information, both for healthcare professionals and consumers, concerning medicinal products. Although many countries around the world have developed regulations intended to govern the promotion of medicinal products, the very nature of the Internet makes it difficult to police. There are both opportunities and risks for the pharma company engaging in promotion using social media. This audio conference presentation examines the laws currently in place in the European Union governing promotion of medicinal products, and how these apply to promotion on the Internet and, in particular, via social media. Our speaker also examines the risks pharmaceutical companies face when establishing corporate websites and social media accounts.
Showing posts with label risk. Show all posts
Showing posts with label risk. Show all posts
Tuesday, November 22, 2011
Friday, August 26, 2011
Customizing and "Right-sizing" Computer Validation
is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Thursday, September 22nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Computer validation isn’t about checking the boxes. It’s about satisfying compliance requirements and meeting business objectives in a productive and useful fashion. Far too often validation resources do not take into consideration why deliverables are generated, and simply say they must be done. Computer validation should not be executed with a cookie-cutter approach, and the thought process and justification should be documented as part of the validation effort.
Computer validation makes sense from a business perspective in that it gives you documented evidence that your computer system is installed, operates and performs per your business requirements. It also gives your organization a control framework and baseline for change management. Approaching computer validation as a value-add to the business to decrease overall costs, rather than just an exercise to ‘check the box’ in a one-size-fits-all validation approach, can satisfy both compliance and corporate objectives.
This audio conference presentation looks at general computer validation approaches in a risk-based world, covering standard procedures that should be in place to support validated systems, and discussing standard computer validation deliverables. Our speaker also reviews when and why deliverables should be generated, where to document when deliverables aren’t generated, and provides real-life examples of computer validation deliverables.
Computer validation isn’t about checking the boxes. It’s about satisfying compliance requirements and meeting business objectives in a productive and useful fashion. Far too often validation resources do not take into consideration why deliverables are generated, and simply say they must be done. Computer validation should not be executed with a cookie-cutter approach, and the thought process and justification should be documented as part of the validation effort.
Computer validation makes sense from a business perspective in that it gives you documented evidence that your computer system is installed, operates and performs per your business requirements. It also gives your organization a control framework and baseline for change management. Approaching computer validation as a value-add to the business to decrease overall costs, rather than just an exercise to ‘check the box’ in a one-size-fits-all validation approach, can satisfy both compliance and corporate objectives.
This audio conference presentation looks at general computer validation approaches in a risk-based world, covering standard procedures that should be in place to support validated systems, and discussing standard computer validation deliverables. Our speaker also reviews when and why deliverables should be generated, where to document when deliverables aren’t generated, and provides real-life examples of computer validation deliverables.
Monday, August 8, 2011
Jagged Little Pill: Are Innovators Liable for Generic Drug Manufacturers' Failure to Warn?
is being presented by Kelly Savage Day & Mike Healy, Senior Associate & Partner, with Sedgwick LLP an airs on Tuesday, August 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The Supreme Court recently held that federal labeling laws preempt state failure-to-warn claims brought against manufacturers of generic drugs. While the 5-4 decision marks a significant win for generic companies, many innovators are concerned that the Court’s ruling may adversely affect their business by making it more likely that other courts will adopt the holding set forth in California’s Conte v. Wyeth decision. Under Conte, brand-name manufacturers may be liable for injuries suffered by those plaintiffs who take a generic version of their brand-name drug.
This audio conference examines the potential legal risks innovators face, and offers concrete suggestions for proactively mitigating these risks. The presentation focuses on the current status of the law concerning innovator-generic liability, featuring speakers with first-hand experience in this litigation and the industry-shaking issues it raises.
The Supreme Court recently held that federal labeling laws preempt state failure-to-warn claims brought against manufacturers of generic drugs. While the 5-4 decision marks a significant win for generic companies, many innovators are concerned that the Court’s ruling may adversely affect their business by making it more likely that other courts will adopt the holding set forth in California’s Conte v. Wyeth decision. Under Conte, brand-name manufacturers may be liable for injuries suffered by those plaintiffs who take a generic version of their brand-name drug.
This audio conference examines the potential legal risks innovators face, and offers concrete suggestions for proactively mitigating these risks. The presentation focuses on the current status of the law concerning innovator-generic liability, featuring speakers with first-hand experience in this litigation and the industry-shaking issues it raises.
Tuesday, March 29, 2011
FDA's 510(k) De Novo Process - Overview and Current Challenges
is being presented by Dr. Zvi Ladin, Principal, with Boston MedTech Advisors and airs on Thursday, April 28th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.
However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.
This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.
Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.
However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.
This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.
Tuesday, November 16, 2010
Risk-Based CAPA - New Guidelines and Expectations
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Tuesday, December 14th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Tuesday, October 12, 2010
Automating Management Systems for Competitiveness & Sustainability
is being presented Jayne Pilot, President, of Pilot Performance Resources Management and airs on Thursday, November 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com
To be competitive on both a national and a global scale, organizations must adopt a forward-thinking approach in developing their management strategies. Many of today’s top managers come from the ranks of the baby boomers, and will reach their 60s and 70s in the next five years and retire from the workforce, taking with them a wealth of knowledge. Automation could help ease the blow by improving competence and competitive advantage for the global marketplace.
But what exactly is an automated management system? What does it encompass, and how can it help companies to be competitive and sustainable? In this audio conference, our speaker outlines how automation of management systems online can help companies manage both risks and sustainability.
To be competitive on both a national and a global scale, organizations must adopt a forward-thinking approach in developing their management strategies. Many of today’s top managers come from the ranks of the baby boomers, and will reach their 60s and 70s in the next five years and retire from the workforce, taking with them a wealth of knowledge. Automation could help ease the blow by improving competence and competitive advantage for the global marketplace.
But what exactly is an automated management system? What does it encompass, and how can it help companies to be competitive and sustainable? In this audio conference, our speaker outlines how automation of management systems online can help companies manage both risks and sustainability.
Wednesday, September 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Thursday, October 14th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Thursday, September 16, 2010
Making Tough R&D Decisions When There Are Multiple Objectives
is being presented by Jack M. Kloeber Jr. & William K. Klimack, Partner & Senior Consultant, with Kromite LLC and airs on Tuesday, October 19th, 2010. For more information, or to register please visit our site at www.fxconferences.com
Making risky, complex decisions affecting the success of a company are part of every R&D leader's day, whether it be in the life sciences or any other industry. As R&D portfolios grow in size, they also grow in complexity, cost, and scientific or engineering difficulty. Executives facing tough decisions are often armed only with their own experience and intelligence and an army of advisors with conflicting objectives.
In this audio conference, our speakers propose a method of decision-making which helps the leader take key conflicting objectives into account consistently, while bringing clarity and transparency to the risk-cost-reward tradeoff discussion. The presentation draws upon a real-life examples from the new product development arena within the pharmaceutical industry. By focusing on achieving the core objectives of the company, leadership can identify the top projects and focus their scarce resources, thereby obtaining the largest value for their R&D efforts.
Making risky, complex decisions affecting the success of a company are part of every R&D leader's day, whether it be in the life sciences or any other industry. As R&D portfolios grow in size, they also grow in complexity, cost, and scientific or engineering difficulty. Executives facing tough decisions are often armed only with their own experience and intelligence and an army of advisors with conflicting objectives.
In this audio conference, our speakers propose a method of decision-making which helps the leader take key conflicting objectives into account consistently, while bringing clarity and transparency to the risk-cost-reward tradeoff discussion. The presentation draws upon a real-life examples from the new product development arena within the pharmaceutical industry. By focusing on achieving the core objectives of the company, leadership can identify the top projects and focus their scarce resources, thereby obtaining the largest value for their R&D efforts.
Tuesday, February 2, 2010
Outsourcing and Offshoring in a New Era of FDA Enforcement
The increasing use of outsourcing and offshoring by FDA-regulated companies for strategic and cost purposes has greatly improved business outcomes and efficiencies. Unfortunately, despite the clear benefits, there are many significant challenges to structuring and managing these relationships to minimize the risk of FDA enforcement, particularly in the new, more aggressive FDA enforcement climate.
In this audio conference, our speaker provides some business context regarding the use of offshoring and outsourcing, and discusses issues and considerations in structuring relationships, as well as considerations in planning for FDA review and inspection of oversight programs.
Outsourcing and Offshoring in a New Era of FDA Enforcement is being presented by John Garvey, Principal, with Compliance Architects, LLC and airs on Thursday, March 11, 2010. For more details or to register, please visit our site at www.fxconferences.com
In this audio conference, our speaker provides some business context regarding the use of offshoring and outsourcing, and discusses issues and considerations in structuring relationships, as well as considerations in planning for FDA review and inspection of oversight programs.
Outsourcing and Offshoring in a New Era of FDA Enforcement is being presented by John Garvey, Principal, with Compliance Architects, LLC and airs on Thursday, March 11, 2010. For more details or to register, please visit our site at www.fxconferences.com
Saturday, October 24, 2009
An Introduction to Analyzing Risk in Medical Devices
Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.
An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com
An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com
Wednesday, July 8, 2009
Best Practices for Managing In-Country Translation Reviews
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
You learn that with proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches.
Best Practices for Managing In-Country Translation Reviews was presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
You learn that with proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches.
Best Practices for Managing In-Country Translation Reviews was presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and is previously recorded. For more details or to download this audio conference, please visit our site at www.fxconferences.com
Friday, June 5, 2009
Oncology Trials in 2009: Challenges & Innovative Approaches
One of the greatest risks for oncology trials today is the delay in clinical development timelines. The main reason for the timeline delay is patient recruitment. Due to the increase in the number of ongoing clinical trials in recent years, and subsequently decreased enrollment in the developed countries, innovative approaches are necessary to mitigate the risk of delay.
To meet clinical development timelines, proactive planning and comprehensive data analysis are necessary to mitigate the risk. Detailed planning and appropriate site and country selection are the most critical factors in meeting target patient accrual goals. This audio conference provides practical guidelines and innovative ideas which are useful when conducting oncology trials in the current environment.
Oncology Trials in 2009: Challenges & Innovative Approaches is being presented by Dr. Ute Berger, Vice President & Head of Medical Affairs - Europe, Africa & Asia-Pacific, with PRA International and airs on Tuesday, July 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
To meet clinical development timelines, proactive planning and comprehensive data analysis are necessary to mitigate the risk. Detailed planning and appropriate site and country selection are the most critical factors in meeting target patient accrual goals. This audio conference provides practical guidelines and innovative ideas which are useful when conducting oncology trials in the current environment.
Oncology Trials in 2009: Challenges & Innovative Approaches is being presented by Dr. Ute Berger, Vice President & Head of Medical Affairs - Europe, Africa & Asia-Pacific, with PRA International and airs on Tuesday, July 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
Thursday, April 16, 2009
Untapped Clinical Development Opportunity in Latin America
Latin America is among the top emerging regions in the world for clinical research, and provides expanding opportunities for biopharmaceutical product development. The region offers rapid access to patients, lower costs of conducting clinical studies, and availability of highly trained professionals for clinical development. Latin America also offers attractive end markets for biopharmaceutical products.
Currently, more than 80% of the regional market share of pharmaceutical sales and growth is distributed among Argentina, Brazil, and Mexico. However, leading biopharmaceutical companies are starting to uncover new opportunities in other Latin American countries, including Costa Rica, the Dominican Republic, Ecuador, Guatemala, Panama, and Venezuela, that have not been traditionally tapped for clinical development. The speakers will review how to unlock this potential through proper planning and a risk-managed approach.
Drawing on extensive expertise, first-hand knowledge, and experience, these experts discuss how biopharmaceutical companies can achieve clinical trial success for both in-country and international marketing approvals. The speakers discuss the pros and cons of conducting clinical research in "non-traditional" Latin American countries, and provide key risk-based approaches.
Untapped Clinical Development Opportunity in Latin America was presented by Dr. Alberto Grignolo, Diego Glancszpigel & Graciela Racaro, Vice President, General Manager, Vice President, Latin America Operations, Senior Director, Latin America Operations, with PAREXEL. This conference aired on 2008-06-05 and is available for download at www.fxconferences.com
Currently, more than 80% of the regional market share of pharmaceutical sales and growth is distributed among Argentina, Brazil, and Mexico. However, leading biopharmaceutical companies are starting to uncover new opportunities in other Latin American countries, including Costa Rica, the Dominican Republic, Ecuador, Guatemala, Panama, and Venezuela, that have not been traditionally tapped for clinical development. The speakers will review how to unlock this potential through proper planning and a risk-managed approach.
Drawing on extensive expertise, first-hand knowledge, and experience, these experts discuss how biopharmaceutical companies can achieve clinical trial success for both in-country and international marketing approvals. The speakers discuss the pros and cons of conducting clinical research in "non-traditional" Latin American countries, and provide key risk-based approaches.
Untapped Clinical Development Opportunity in Latin America was presented by Dr. Alberto Grignolo, Diego Glancszpigel & Graciela Racaro, Vice President, General Manager, Vice President, Latin America Operations, Senior Director, Latin America Operations, with PAREXEL. This conference aired on 2008-06-05 and is available for download at www.fxconferences.com
Monday, April 13, 2009
Predicting and Preventing Protocol Violations
Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.
This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.
Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com
This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.
Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com
Thursday, April 9, 2009
Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World
One of the provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is that the FDA requires manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug or biologic first comes on the market, or later if they become aware of new safety data about the drug. What risk signals should be looked for early in the development process?
In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated actvities that begin with early clinical testing are key, and must continue throughout the product lifecycle.
Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World is being presented by Dr. Edgar Adams & Robin Carter, Executive Director, Epidemiology & Senior Director, Risk Management Operations, with Covance, and airs on Tuesday, May 5, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated actvities that begin with early clinical testing are key, and must continue throughout the product lifecycle.
Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World is being presented by Dr. Edgar Adams & Robin Carter, Executive Director, Epidemiology & Senior Director, Risk Management Operations, with Covance, and airs on Tuesday, May 5, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
Tuesday, March 3, 2009
Hazard Analysis for Medical Devices Under IEC60601 and ISO14971
If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 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.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 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.
Wednesday, December 10, 2008
Risk Management Best Practices for Medical Devices
Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.
This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.
Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com
This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.
Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com
Wednesday, October 29, 2008
Optimizing Site Performance: Risk Planning vs. Remediation
What causes the widespread variance in site performance in clinical trials, declining data quality and missed timelines? What can drug development service providers and sponsors proactively do to optimize site performance?
A large percentage of clinical trial budgets is allocated to fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors. This audio conference discusses protocol violations as a consequence of stressed environmental conditions at investigative sites. The presentation looks at why these violations are so pervasive, and the inability of conventional measures to adequately detect and address them. The speaker then discusses how protocol violations are preventable within a risk management paradigm, and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).
Optimizing Site Performance: Risk Planning vs. Remediation is being presented by Pam Atwell, Director, Operational Strategies and Planning, of Covance Clinical Development Services and airs Thursday, Dec. 4, 2008. For more details or to register, please visit our site www.fxconferences.com
A large percentage of clinical trial budgets is allocated to fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors. This audio conference discusses protocol violations as a consequence of stressed environmental conditions at investigative sites. The presentation looks at why these violations are so pervasive, and the inability of conventional measures to adequately detect and address them. The speaker then discusses how protocol violations are preventable within a risk management paradigm, and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).
Optimizing Site Performance: Risk Planning vs. Remediation is being presented by Pam Atwell, Director, Operational Strategies and Planning, of Covance Clinical Development Services and airs Thursday, Dec. 4, 2008. For more details or to register, please visit our site www.fxconferences.com
Thursday, September 11, 2008
Introduction to ISO 13485:2003 and ISO 14969
ISO 13485:2003 has hit the street several years ago. Understanding the impact that these standards have on devices and diagnostics will help you to develop a forward-looking ISO strategy.
Drawing on her work with industry-leading device and diagnostic companies on ISO standards, Sue Spencer discusses the technical and strategic challenges being faced by those charged with maintain ISO. This audio conference walks you through the maze of updates to ISO 13485:2003 and provides insight to supporting guidance document ISO 14969.
Introduction to ISO 13485:2003 and ISO 14969 was recorded on 2003-07-16 and is now available for download at www.fxconferences.com
Drawing on her work with industry-leading device and diagnostic companies on ISO standards, Sue Spencer discusses the technical and strategic challenges being faced by those charged with maintain ISO. This audio conference walks you through the maze of updates to ISO 13485:2003 and provides insight to supporting guidance document ISO 14969.
Introduction to ISO 13485:2003 and ISO 14969 was recorded on 2003-07-16 and is now available for download at www.fxconferences.com
Monday, September 8, 2008
The EU Perspective on Risk Management
Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.
In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.
The EU Perspective on Risk Management was recorded on 2007-07-19 and will replay on September 16th, 2008 at 11:30 Eastern time. For more information on this audio conference, please visit our site www.fxconferences.com
In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.
The EU Perspective on Risk Management was recorded on 2007-07-19 and will replay on September 16th, 2008 at 11:30 Eastern time. For more information on this audio conference, please visit our site www.fxconferences.com
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