is being presented by Kathleen Mandziuk & Cathy Michael, Scientific Affairs Director & Senior Director of Comprehensive Solutions, with PRA & BioStorage Technologies and airs on Thursday, May 3rd, 2012. For more details or to register, please visit our site at www.fxconferences.com
*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*
Webinar highlights
The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.
This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.
Wednesday, April 25, 2012
Tuesday, April 24, 2012
What's New with Investigational Device Exemptions (IDE)?
is being presented by Cheryl Hill, Regulatory Manager, with Pleiad Inc. and airs on Wednesday, May 2nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Monday, April 23, 2012
FSMA and Traceability – Complying With FDA's New Requirements
is being presented by Pamela Sweeten, Principal, of P. Sweeten Consulting and airs on Tuesday, May 1st, 2012. For more details or to register, please visit our site at www.fxconferences.com
Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?
This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.
Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?
This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.
Friday, April 20, 2012
Managing Legal and PR Risks in Social Media
is being presented by Allison Fitzpatrick & Laura J. Protzmann, Partner & Counsel, of Davis & Gilbert LLP & The Dannon Company, Inc. and airs on Thursday, April 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com
With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.
Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.
With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.
Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.
Thursday, April 19, 2012
The Foreign Supplier Verification Program and What It Means for the Food Industry
is being presented by Marc C. Sanchez, Regulatory Counsel, with Contract In-House Counsel and Consultants, LLC and airs on Wednesday, April 25th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.
In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.
The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.
In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.
Wednesday, April 18, 2012
Medical Device Reimbursement in China
is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, April 24th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.
This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.
Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.
This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.
Monday, April 16, 2012
Agile Software Development in the Medical Device Industry
is being presented by Janet Balk, Principal, with Agile FDA and airs on Thursday, April 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D. This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities.
Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D. This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities.
Wednesday, April 11, 2012
Developing a Sampling Plan for Quality Audits
is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC and airs on Thursday, April 19th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.
This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)
Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.
This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)
Monday, April 9, 2012
Investigator Brochures for Medical Devices
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.
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.
Tuesday, April 3, 2012
Best Practices for Conducting Clinical Trials in Emerging Countries
is being presented by Dr. Nermeen Varawalla, CEO, of ECCRO and airs on Tuesday, April 17th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.
Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.
The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.
Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.
Monday, April 2, 2012
FDA Update – Responding to Unsolicited Requests for Off-Label Information
is being presented by Marian J. Lee & Beverly H. Lorell, Partner & Senior Advisor, with King & Spalding LLP and airs on Thursday, April 12th, 2012. For more details, or to register please visit our site at www.fxconferences.com
FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
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