is being presented by Anthony L. Fitzhugh, M.D., Project Manager/Lead Auditor, with TUV SUD America Inc. and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Annex X of the Medical Device Directive (EC Directive 93/42/EEC) requires that a manufacturer who seeks to place a medical device on the market in the EU first conduct and document in the technical file/design dossier a clinical evaluation that fully evaluates the safety and efficacy of the device. An amendment (2007/47/EEC) to the Medical Device Directive—published in 2007— has made this requirement even more stringent than in the recent past. The clinical evaluation must now be documented in such a manner that this section of the file comprises a standalone document. Moreover, all manufacturers must actively maintain their compliance with the aforementioned clinical requirements as well as post-market clinical follow-up—unless it can be shown to be not necessary.
As a result of these changes, those working in regulatory affairs must ensure that they have the proper expertise and strategy in place to allow their company to comply with these requirements prior to and after placement of their medical device on the EU market. This audio conference presentation covers the EU regulatory framework for meeting the revised clinical requirements, as well as strategies for maintaining the clinical data section of the technical file or design dossier.
Tuesday, August 30, 2011
Monday, August 29, 2011
Avoiding FDA 483s, Warning Letters and Recalls with Harmonized Supplier Qualification
is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, September 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA’s Office of Compliance is reorganizing to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. The presentation highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Our speaker also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
The FDA’s Office of Compliance is reorganizing to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. The presentation highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Our speaker also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
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.
Thursday, August 25, 2011
Budgeting for Translations
is being presented by Jason Heaton, with ForeignExchange Translations, Inc. and airs on Wednesday, September 21st, 2011. For more details, or to register please visit our site at www.fxconferences.com
Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.
The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.
This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.
Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.
The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.
This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.
Wednesday, August 24, 2011
CLIA Waiver Submissions – Common Mistakes, Recent Trends and FDA's Plans for the Future
is being presented by Dr. Gail E. Radcliffe, President, of Radcliffe Consulting and airs on Tuesday, September 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.
Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.
Tuesday, August 23, 2011
Finding the Optimal Regulatory Pathway for Your Combination Product
is being presented by Suzanne O'Shea, Of Counsel, with Baker & Daniels, LLP and airs on Thursday, September 15th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.
This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.
Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.
This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.
Monday, August 22, 2011
Cleaning Validation: Reducing Downtime with Compliance
is being presented by Todd Arney, Principle Consultant, with Technical & Quality Services, LLC and airs on Wednesday, September 14th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference presentation provides attendees with the latest information on industry standards for cleaning and cleaning validation, as well as a discussion of the current regulatory requirements and FDA guidance on the subject. Our speaker shares his wealth of experience and insight on the impact of cleaning and cleaning validation on turnover time, and how it affects overall capacity in the operating environment. Attendees learn how to implement a robust cleaning and cleaning validation program "brick by brick" in their own facilities, including cleaning procedure design, limits and matrix approach, troubleshooting failure, and presenting validation documents to regulators.
This audio conference presentation provides attendees with the latest information on industry standards for cleaning and cleaning validation, as well as a discussion of the current regulatory requirements and FDA guidance on the subject. Our speaker shares his wealth of experience and insight on the impact of cleaning and cleaning validation on turnover time, and how it affects overall capacity in the operating environment. Attendees learn how to implement a robust cleaning and cleaning validation program "brick by brick" in their own facilities, including cleaning procedure design, limits and matrix approach, troubleshooting failure, and presenting validation documents to regulators.
Thursday, August 18, 2011
In-Vitro Diagnostics: Testing Times
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.
In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.
Wednesday, August 17, 2011
FDA and FTC Enforcement of Health and Structure/Function Claims
is being presented by Mark Mansour & Emily K. Strunk, Partner & Associate, with Akin Gump Strauss Hauer & Feld, LLP and airs on Wednesday, September 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Are berries "super food"? Does green tea protect against cancer? Can whole grains lower your cholesterol? And even if they do, can you say that on your food labels and advertising?
Health claims and structure/function claims for food and dietary supplement products are jointly regulated by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). As food labeling and marketing professionals get more creative in an effort to distinguish their products in a crowded marketplace and appeal to the increasingly health-conscious consumer, FDA and FTC have stepped up enforcement efforts to ensure that consumers are getting accurate information. Bad actors should beware, but even companies with the best intentions can land in hot water if claims are not properly vetted. Sometimes just a word can make the difference between a claim that violates the law and one that complies.
This audio conference provides attendees with an overview of FDA and FTC authority to regulate health and structure/function claims, a discussion of the current regulatory and enforcement climate including pending policy changes, and some tips on how food and supplement companies can avoid enforcement action.
Are berries "super food"? Does green tea protect against cancer? Can whole grains lower your cholesterol? And even if they do, can you say that on your food labels and advertising?
Health claims and structure/function claims for food and dietary supplement products are jointly regulated by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). As food labeling and marketing professionals get more creative in an effort to distinguish their products in a crowded marketplace and appeal to the increasingly health-conscious consumer, FDA and FTC have stepped up enforcement efforts to ensure that consumers are getting accurate information. Bad actors should beware, but even companies with the best intentions can land in hot water if claims are not properly vetted. Sometimes just a word can make the difference between a claim that violates the law and one that complies.
This audio conference provides attendees with an overview of FDA and FTC authority to regulate health and structure/function claims, a discussion of the current regulatory and enforcement climate including pending policy changes, and some tips on how food and supplement companies can avoid enforcement action.
Tuesday, August 16, 2011
Conducting Medical Device Studies Under the Revised ISO 14155
is being presented by Janette Benaddi, CEO, with Medvance and airs on Tuesday, September 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.
In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.
The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.
In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.
Friday, August 12, 2011
Writing for a Global Audience
is being presented by Sonja Jacobsen, Manager of Project Services, with ForeignExchange Translations and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Ideally, developing content for a global audience takes into account translation considerations during the English authoring phase. However, translation and localization issues in the source material often only come to light during translation. This generally means a longer and most likely a costlier translation phase than most companies had anticipated, and can sometimes necessitate changes to the source content after it has already been released.
This audio conference presentation is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker seeks to explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.
Ideally, developing content for a global audience takes into account translation considerations during the English authoring phase. However, translation and localization issues in the source material often only come to light during translation. This generally means a longer and most likely a costlier translation phase than most companies had anticipated, and can sometimes necessitate changes to the source content after it has already been released.
This audio conference presentation is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker seeks to explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.
Wednesday, August 10, 2011
Government Enforcement on Medical Affairs and Commercial-Related Activities
is being presented by Jamie L. Kendall, Esq., Sr. Director, with Compliance Implementation Services, LLC and airs on Wednesday, September 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.
Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.
This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.
Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.
Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.
This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.
Tuesday, August 9, 2011
Best Practices for Managing In-Country Translation Reviews
is being presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and airs on Wednesday, August 31st, 2011. For more details on this event or to register, please visit our site at www.fxconferences.com
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.
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. This presentation shows you how.
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.
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. This presentation shows you how.
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.
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