is being presented by Faiz Kermani, President, of Global Health Education Foundation and airs on Thursday, October 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Emerging markets, such as India, China, Mexico and Brazil have experienced a surge in popularity as locations for outsourced clinical research. A wider availability of patients, low operational costs, and positive patient attitudes towards clinical trials have driven this trend. This has further significance given that these emerging regions are also becoming important markets for new products.
However, in expanding clinical research to these regions, sponsors must be careful not to overlook linguistic and cultural differences among the various patient populations. Language and culture are also important factors in dealing with local regulatory authorities and governmental agencies. It is also imperative that sponsors understand that by extending their reach to emerging regions, there are difficult questions to answer in how best to involve subjects in clinical trials and yet not be seen to be exploiting them. This presentation will summarize key linguistic and cultural themes impacting global clinical research, and suggest best practices for leveraging the opportunities of emerging markets while avoiding the pitfalls.
Friday, September 30, 2011
Tuesday, September 27, 2011
The FDA and Social Media
is being presented by Kelly Savage Day, Senior Associate, with Sedgwick LLP and airs on Wednesday, October 26th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In this brave new world of Twitter, Facebook, LinkedIn and other social media websites, risk and opportunity may be combined. There is no question that social networking represents the emergence of a tremendous marketing and customer education opportunity, but there are also pitfalls for the FDA-regulated company. What happens if you go too far, say too much? Do you need to be concerned about the use of these networking sites by employees?
This audio conference presentation tackles some of the important issues that social media poses for life science companies – the benefits, risks, and mitigating that risk – and provides insight on how to use social media to positively impact your business, without running afoul of regulators.
In this brave new world of Twitter, Facebook, LinkedIn and other social media websites, risk and opportunity may be combined. There is no question that social networking represents the emergence of a tremendous marketing and customer education opportunity, but there are also pitfalls for the FDA-regulated company. What happens if you go too far, say too much? Do you need to be concerned about the use of these networking sites by employees?
This audio conference presentation tackles some of the important issues that social media poses for life science companies – the benefits, risks, and mitigating that risk – and provides insight on how to use social media to positively impact your business, without running afoul of regulators.
Monday, September 19, 2011
Sample Size for Design Verification and Validation
is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Thursday, October 20th, 2011. 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.
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, September 16, 2011
Energy Tax Incentives and Prospects for Reform
is being presented by Patrick Bousliman, Senior Policy Advisor, Holland & Knight, LLP and airs on Tuesday, October 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com
What lies in store for the energy industry and its tax treatment? This audio conference presentation looks at energy tax incentives, particularly those for wind and solar power, in the context of growing budget deficits and Super Committee deliberations. Our speaker discusses the prospects for extending the production tax credit (PTC) for wind facilities, as well as the investment tax credit (ITC) for solar projects. The wind credit expires next year, and the industry will push hard for its extension. The solar credit doesn't expire until 2016, but many in the industry are concerned that the ITC will be targeted if incentives for other energy industries - such as oil and gas - are considered for repeal or modification. To that end, the speaker provides insight on deliberations of the Joint Select Committee, also known as the Super Committee, including what, if anything, that 12-person group might agree to. Finally, the presentation addresses options for reform of energy tax expenditures, including proposals to tie these expenditures to a performance standard.
What lies in store for the energy industry and its tax treatment? This audio conference presentation looks at energy tax incentives, particularly those for wind and solar power, in the context of growing budget deficits and Super Committee deliberations. Our speaker discusses the prospects for extending the production tax credit (PTC) for wind facilities, as well as the investment tax credit (ITC) for solar projects. The wind credit expires next year, and the industry will push hard for its extension. The solar credit doesn't expire until 2016, but many in the industry are concerned that the ITC will be targeted if incentives for other energy industries - such as oil and gas - are considered for repeal or modification. To that end, the speaker provides insight on deliberations of the Joint Select Committee, also known as the Super Committee, including what, if anything, that 12-person group might agree to. Finally, the presentation addresses options for reform of energy tax expenditures, including proposals to tie these expenditures to a performance standard.
Thursday, September 15, 2011
Developments, Trends and the Future of Neurological Devices
is being presented by Jessica Swartz, Consultant, with IMS Consulting Group and airs on Thursday, October 13th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Neurostimulators are becoming increasingly prevalent in the treatment of a number of serious medical conditions, including Parkinson’s disease, epilepsy, depression and chronic pain. As market opportunities expand, companies are seeking ways to differentiate themselves and increase their clinical reach. This audio conference presentation provides an overview of both current and developmental neuorstimulation devices, and discusses the commercial and clinical significance of these therapies.
Our speaker examines how neurostimulation may affect the clinical management of nervous system disorders in the future, and provides strategic insight into the commercial relevance of these therapies. The presentation also discusses similarities and differences between the various devices, as well as potential opportunities within the neurological stimulator market.
Neurostimulators are becoming increasingly prevalent in the treatment of a number of serious medical conditions, including Parkinson’s disease, epilepsy, depression and chronic pain. As market opportunities expand, companies are seeking ways to differentiate themselves and increase their clinical reach. This audio conference presentation provides an overview of both current and developmental neuorstimulation devices, and discusses the commercial and clinical significance of these therapies.
Our speaker examines how neurostimulation may affect the clinical management of nervous system disorders in the future, and provides strategic insight into the commercial relevance of these therapies. The presentation also discusses similarities and differences between the various devices, as well as potential opportunities within the neurological stimulator market.
Wednesday, September 14, 2011
How to Minimize or Eliminate In-country Reviews Without Sacrificing Translation Quality
is being presented by Sonia Monahan, Executive Vice President of Quality Systems, with ForeignExchange Translations and airs on Wednesday, October, 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Every day another international labeling project is set up with its highest element of risk smack-dab at the end of the process. Quality validation is extremely important, especially in regulated industries, and validating translation quality is often accomplished by holding in-country reviews. This step typically consists of employees in local offices completing an assessment of the translation quality. The risks of this step are large, and include missed product launches due to delays in completing in-country reviews, and quality errors introduced by non-linguists during reviews.
In a recent survey on linguistic quality, respondents from the medical device industry, translation service providers, and professional language translators were asked, “What is your biggest translation challenge?”. The number-one answer was “in-country reviews”. The top answer to the question “How is quality measured?” was, ironically, “in-country review feedback”. But are in-country reviews an absolute necessity in order to achieve optimal translation quality? This audio conference examines ways to minimize or even remove the in-country review step from the translation cycle, while still adhering to regulatory and corporate requirements for translation validation.
Every day another international labeling project is set up with its highest element of risk smack-dab at the end of the process. Quality validation is extremely important, especially in regulated industries, and validating translation quality is often accomplished by holding in-country reviews. This step typically consists of employees in local offices completing an assessment of the translation quality. The risks of this step are large, and include missed product launches due to delays in completing in-country reviews, and quality errors introduced by non-linguists during reviews.
In a recent survey on linguistic quality, respondents from the medical device industry, translation service providers, and professional language translators were asked, “What is your biggest translation challenge?”. The number-one answer was “in-country reviews”. The top answer to the question “How is quality measured?” was, ironically, “in-country review feedback”. But are in-country reviews an absolute necessity in order to achieve optimal translation quality? This audio conference examines ways to minimize or even remove the in-country review step from the translation cycle, while still adhering to regulatory and corporate requirements for translation validation.
Tuesday, September 13, 2011
EU Regulatory Requirements for Medical Devices Utilizing Tissues of Animal Origin
is being presented by Steve Coppock, MHS Auditor, with TÜV SÜD America, Inc and airs on Tuesday, October 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.
Monday, September 12, 2011
Complying with EU Requirements for Medical Device Software
is being presented by Poul Schmidt-Andersen, Managing Partner, with Danish Medical Devices Consulting and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.
Wednesday, September 7, 2011
Driving Your Quality System With Effective Management Controls
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Thursday, October 6th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Over the last five years, management controls made up approximately 15% of all warning letters by subsystem annually. There is a scarcity of information and presentations on management controls even though it is the most important aspect of the quality system. This presentation will detail the importance of management controls in driving a quality organization.
It is up to management to ensure that an effective and sustainable quality system is implemented appropriate to the organization’s products and processes. Management should set the vision, strategy and goals, and this should be communicated to everyone within the organization. Leading by example and focusing on quality are keys to success. This audio conference presentation looks at how effective management controls lead to successful quality-centric and profitable organizations, as our speaker shares organizational best practices in this key area.
Over the last five years, management controls made up approximately 15% of all warning letters by subsystem annually. There is a scarcity of information and presentations on management controls even though it is the most important aspect of the quality system. This presentation will detail the importance of management controls in driving a quality organization.
It is up to management to ensure that an effective and sustainable quality system is implemented appropriate to the organization’s products and processes. Management should set the vision, strategy and goals, and this should be communicated to everyone within the organization. Leading by example and focusing on quality are keys to success. This audio conference presentation looks at how effective management controls lead to successful quality-centric and profitable organizations, as our speaker shares organizational best practices in this key area.
Tuesday, September 6, 2011
Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting and airs on Wednesday, October 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
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