is being presented by Dr. Susan Sisk, Principal, SFP Consulting, LLC and airs on Thursday, August 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Many times, tables and listings used for preparing clinical study reports, integrated summaries, and other clinical documents are designed without closely considering how these data displays will be used by the writer and review team to expedite document preparation and support messages about healthcare products. For example, does placebo come first on your tables and, if so, does that mean placebo is first in the text, or are you more interested in the test drug, mentioning placebo in context as a comparator? Or, have you ever written narratives from listings that required you to look up information in dozens of fields and then to do manual calculations to obtain “durations” required by the template, rather than the date-formatted data provided in the displays?
This audio conference presentation is designed to educate and to provoke dialog between statisticians and writers, as well as medical, regulatory, and project managers, with respect to appropriate display of clinical information to expedite document preparation and review.
Thursday, July 21, 2011
Wednesday, July 20, 2011
Conducting Formative and Summative Usability Studies for Medical Devices
is being presented by Adam R. Shames, Director, Human Factors Research, with Design Science Consulting, Inc. and airs on Wednesday, August 24th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.
Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.
The FDA expects it, your customers need it, and if you do it right, usability testing will all but guarantee that your product is a success. Done wrong, your product will never see its commercial launch.
Drawing on several real-life case studies, this audio conference presents attendees with a roadmap for conducting formative usability studies that lead to a successful summative study. Our speaker reviews the relevant standards such as IEC 62366, HE 75, and the FDA draft guidance entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 22, 2011). The presentation provides insight on what device manufacturers need to do – and what not to do – to assure that their product passes its user-interface design validation, and demonstrate to the FDA that they have developed a safe and effective medical device.
Monday, July 18, 2011
Speaking opportunities at our audio conferences and webinars
Does your company cater to the medical device, IVD, pharma, or biotech industries? Are you interested in sharing your expertise with other industry professionals?The key element to the success of our ongoing FX Conferences audio conference series is the speaker relationships forged behind the scenes. We seek out and partner with thought leaders in the life sciences to bring our audience the latest information and guidance on industry hot topics - topics like regulatory submissions, clinical evaluations, human factors engineering and off-label promotion.
Many of our speaker partners have been working with us for years, having seen tangible value in showcasing their expertise to a targeted audience of life sciences executives. We share with our speakers all of the business development leads arising from each event, and offer the opportunity for revenue sharing as well. We strive to create win-win relationships with our speakers, and many of them have realized business opportunities as a result of their work with us.
Interested in finding out more? Get in touch with Rob Wagner at acsupport@fxtrans.com!
For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
Thursday, July 14, 2011
Off-label Investigations: Recent Actions, Settlements and Enforcement Trends
is being presented by John E. Kelly & Cori Annapolen Goldberg, Partner & Senior Associate, with Fulbright & Jaworski L.L.P and airs on Wednesday, August 17th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Fighting health care fraud has been one of the current administration’s top law enforcement priorities. The past few years have seen bold and pointed steps by the Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) as well as federal lawmakers intent on proving the government’s commitment to the crackdown on health care fraud.
In the last two years, the DOJ has pursued and recovered a record amount of taxpayer dollars lost to health care fraud – more than in any other two-year period in the Department’s history. A major part of these recent recoveries comes from settlements involving off-label marketing and promotions by drug and device manufacturers. In 2009, DOJ announced the largest federal health care fraud takedown in U.S. history, which included the largest criminal fine ever imposed in the U.S. for any matter. The reason for the investigation and takedown? Off-label marketing.
With the government’s aggressive crackdown on health care fraud and abuse, it is imperative that companies arm themselves with the knowledge to identify risk areas and to protect themselves against government investigations that could cost billions in fines, penalties, and legal fees. This presentation looks at recent health care fraud and abuse as it relates to off-label marketing, and ways in which companies can protect themselves from undue scrutiny.
Fighting health care fraud has been one of the current administration’s top law enforcement priorities. The past few years have seen bold and pointed steps by the Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) as well as federal lawmakers intent on proving the government’s commitment to the crackdown on health care fraud.
In the last two years, the DOJ has pursued and recovered a record amount of taxpayer dollars lost to health care fraud – more than in any other two-year period in the Department’s history. A major part of these recent recoveries comes from settlements involving off-label marketing and promotions by drug and device manufacturers. In 2009, DOJ announced the largest federal health care fraud takedown in U.S. history, which included the largest criminal fine ever imposed in the U.S. for any matter. The reason for the investigation and takedown? Off-label marketing.
With the government’s aggressive crackdown on health care fraud and abuse, it is imperative that companies arm themselves with the knowledge to identify risk areas and to protect themselves against government investigations that could cost billions in fines, penalties, and legal fees. This presentation looks at recent health care fraud and abuse as it relates to off-label marketing, and ways in which companies can protect themselves from undue scrutiny.
Wednesday, July 13, 2011
Written Food Safety Plan Compliance Under the FSMA
is being presented by Shawn K. Stevens, National Food Safety Lawyer, with Gass Weber Mullins LLC and airs on Thursday, August 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Anyone involved in the food industry has heard about the new Food Safety Modernization Act (FSMA). Enacted in January 2011, the FSMA makes sweeping changes to the way food products are manufactured, distributed and regulated.
Although the FSMA imposes many new requirements on the food industry, the one that will likely have the greatest impact is the requirement that, prior to June 2012, food companies adopt and implement written food safety plans. In regulatory and legal terms, this means that regulated food companies will be required to develop and then closely follow a hazard analysis and critical control point (HACCP) methodology. Thus, whether you import, process or distribute food products, the new legislation can and will substantially impact the nature of your business.
This audio conference provides attendees with an overview of the new FDA requirements, along with how and when FDA will likely begin enforcing them, and how best to prepare your business for the coming changes.
Anyone involved in the food industry has heard about the new Food Safety Modernization Act (FSMA). Enacted in January 2011, the FSMA makes sweeping changes to the way food products are manufactured, distributed and regulated.
Although the FSMA imposes many new requirements on the food industry, the one that will likely have the greatest impact is the requirement that, prior to June 2012, food companies adopt and implement written food safety plans. In regulatory and legal terms, this means that regulated food companies will be required to develop and then closely follow a hazard analysis and critical control point (HACCP) methodology. Thus, whether you import, process or distribute food products, the new legislation can and will substantially impact the nature of your business.
This audio conference provides attendees with an overview of the new FDA requirements, along with how and when FDA will likely begin enforcing them, and how best to prepare your business for the coming changes.
Monday, July 11, 2011
Section 1603 – Qualifying for 2011 & Planning for the Future
is being presented by Gregory F. Jenner, Partner, with Stoel Rives LLP and airs on Thursday, August 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The 1603 grant has been both a lifesaver and a game changer for the renewable energy sector. However, section 1603 is likely going the way of the dodo after 2011 unless construction has begun on a project before then. Therefore, it is imperative that developers and others understand how to meet the alternative tests for beginning construction. In addition, moving beyond 2011, the sunset of section 1603 will place increased emphasis on optimizing the use of tax equity and the various structures that are available.
This audio conference presentation focuses on qualifying for 1603 for the balance of 2011, and also reviews the available structures used to monetize tax incentives – including partnership flips, sale-leaseback transactions, leases with credit pass-through arrangements, and prepayment structures. Our speaker discusses the advantages and disadvantages of each, and provides attendees with insight and guidance to help them prepare for life after section 1603.
The 1603 grant has been both a lifesaver and a game changer for the renewable energy sector. However, section 1603 is likely going the way of the dodo after 2011 unless construction has begun on a project before then. Therefore, it is imperative that developers and others understand how to meet the alternative tests for beginning construction. In addition, moving beyond 2011, the sunset of section 1603 will place increased emphasis on optimizing the use of tax equity and the various structures that are available.
This audio conference presentation focuses on qualifying for 1603 for the balance of 2011, and also reviews the available structures used to monetize tax incentives – including partnership flips, sale-leaseback transactions, leases with credit pass-through arrangements, and prepayment structures. Our speaker discusses the advantages and disadvantages of each, and provides attendees with insight and guidance to help them prepare for life after section 1603.
Friday, July 8, 2011
Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, August 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Wednesday, July 6, 2011
Process Validation – Implementing the Finalized FDA Guidance
is being presented by Todd Arney, Principal Consultant, with Technical & Quality Services, LLC and airs on Thursday, August 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com
This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.
The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.
This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.
The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.
Tuesday, July 5, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Tuesday, August 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
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