is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, April 4th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Friday, March 30, 2012
Thursday, March 29, 2012
Avoiding and Responding to FDA Import Alerts
is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Tuesday, April 3rd, 2012. For more details, or to register please visit our site at www.fxconferences.com
When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.
This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.
When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.
This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.
Monday, March 26, 2012
Human Subject Protection Programs - Analyzing the New Proposed Regulations
is being presented by Eric Allen, Director, Office of Research Compliance, with University of North Carolina at Greensboro and airs on Thursday, March 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com
For the first time in more than 20 years, the Office of Human Research Protections is reviewing the federal regulations governing protection of human subjects. It will be the first substantive change to these regulations since 1991, and the potential impact will affect all individuals who are currently involved in human subject research and those who plan to be in the future.
Overall, this is a much-needed document for the human subject research community. There are a few areas in particular that will be improved by this new legislation, such as regularly updated expedited review categories and improved accountability for research as a whole. However, the majority of the changes provide great concern for investigators, IRBs, institutional officials, potential research subjects, and regulatory compliance administrators, as the revisions will drastically alter the way research is conducted, reviewed, and perceived by the general public.
In this audio conference presentation, our speaker analyzes the newly proposed human subject regulations in the context of their current state, highlighting significant changes and pointing out critical concerns and areas that need further clarification.
For the first time in more than 20 years, the Office of Human Research Protections is reviewing the federal regulations governing protection of human subjects. It will be the first substantive change to these regulations since 1991, and the potential impact will affect all individuals who are currently involved in human subject research and those who plan to be in the future.
Overall, this is a much-needed document for the human subject research community. There are a few areas in particular that will be improved by this new legislation, such as regularly updated expedited review categories and improved accountability for research as a whole. However, the majority of the changes provide great concern for investigators, IRBs, institutional officials, potential research subjects, and regulatory compliance administrators, as the revisions will drastically alter the way research is conducted, reviewed, and perceived by the general public.
In this audio conference presentation, our speaker analyzes the newly proposed human subject regulations in the context of their current state, highlighting significant changes and pointing out critical concerns and areas that need further clarification.
Friday, March 23, 2012
eLabeling Medical Devices for the EU Market
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, March 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Tuesday, March 20, 2012
Establishing Effective and FDA-Compliant Good Clinical Practices (GCP)
is being presented by Dr. David Lim, Founder, of Regulatory Doctor and airs on Tuesday, March 27th, 2012. For more details, or to register please visit our site at www.fxconferences.com
In the United States, scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices (including in vitro diagnostic devices) are regulated by the Food and Drug Administration (FDA). Those conducting these clinical studies – such as clinical investigators, sponsors, monitors, and CROs – must comply with the applicable statutes and regulations governing good clinical practice (GCP).
This audio conference presentation is intended to provide attendees with a detailed review and understanding of the FDA regulations applicable for clinical trials or studies, and requirements for compliance. Our speaker drawns upon extensive industry experience and shares insight on the various aspects of GCP, empowering attendees with the key information they need regarding FDA regulations and requirements.
In the United States, scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices (including in vitro diagnostic devices) are regulated by the Food and Drug Administration (FDA). Those conducting these clinical studies – such as clinical investigators, sponsors, monitors, and CROs – must comply with the applicable statutes and regulations governing good clinical practice (GCP).
This audio conference presentation is intended to provide attendees with a detailed review and understanding of the FDA regulations applicable for clinical trials or studies, and requirements for compliance. Our speaker drawns upon extensive industry experience and shares insight on the various aspects of GCP, empowering attendees with the key information they need regarding FDA regulations and requirements.
Monday, March 19, 2012
New Paradigm – Drug Development Partnerships and Their Impact on Quality
is being presented by Dr Pete Harpum, Harpum Consulting and airs on Thursday, March 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
The focus of work in the drug development industry is inexorably moving away from vertically integrated pharmaceutical and biotechnology companies – the ‘sponsors’ – to contract research organizations (CROs) and other third-party suppliers of services. Approximately 350,000 people have left employment in pharmaceutical and biotechnology companies – but they did not leave the industry. Many of these people moved from the sponsor/client side to the CRO/seller side. Drug development work is now increasingly done by third parties: the challenge facing industry is how to maintain and improve quality of service?
Partnering is a valuable strategy for clients and sellers to work together. In this presentation our speaker draws upon the lessons of other industries in which the majority of work is carried out by third parties in partnership with buyers, and looks at how partnering can facilitate high quality service provision by CROs.
The focus of work in the drug development industry is inexorably moving away from vertically integrated pharmaceutical and biotechnology companies – the ‘sponsors’ – to contract research organizations (CROs) and other third-party suppliers of services. Approximately 350,000 people have left employment in pharmaceutical and biotechnology companies – but they did not leave the industry. Many of these people moved from the sponsor/client side to the CRO/seller side. Drug development work is now increasingly done by third parties: the challenge facing industry is how to maintain and improve quality of service?
Partnering is a valuable strategy for clients and sellers to work together. In this presentation our speaker draws upon the lessons of other industries in which the majority of work is carried out by third parties in partnership with buyers, and looks at how partnering can facilitate high quality service provision by CROs.
Wednesday, March 14, 2012
Monitoring Essentials for Medical Device Trials
is being presented by Helen Colquhoun, CEO, Pleiad Inc. and airs on Wednesday, March 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Monday, March 12, 2012
The Revised RoHS Directive and What It Means for Device Manufacturers
is being presented by Dr. Joachim Wilke, Director, Regulatory Affairs & Policy, Europe, with Medtronic and airs on Thursday, March 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
Friday, March 9, 2012
Improving Study Feasibility- Why Sites Fail and How to Avoid It
is being presented by Nikki Christison, President, of Clinical Resolutions and airs on Wednesday, March 14th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.
Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.
This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.
Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.
Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.
This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.
Monday, March 5, 2012
Industry Update – China's Evolving Medical Device Regulations
is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, March 13th, 2012. For more details, or to register please visit our site at www.fxconferences.com
China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.
This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.
China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.
This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.
Thursday, March 1, 2012
Post-market Design Changes – What FDA is Saying Now
is being presented by David Rothkopf, President, of MEDIcept and airs on Tuesday, March 13th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.
In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).
Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.
In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).
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