is being presented by Marian J. Lee & Dr. Beverly H. Lorell, Partner & Senior Medical and Policy Advisor, with King & Spalding LLP and airs on Thursday, March 8th, 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FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products.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 The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
Monday, February 27, 2012
Tuesday, February 21, 2012
Writing Web Content That Works
is being presented by Janice Redish, President, of Redish & Associates, Inc and airs on Wednesday, March 7th, 2012. For more details or to register, please visit our site at www.fxconferences.com
People come to websites for the content. They come to fulfill a need, to do a task, to get the answer to a question. Clear navigation, good design, and search engines that work are all critical, of course, but they are all there to support the content. Are you paying enough attention to the content on your website – both to what your messages are and to how you are presenting those messages? In this audio conference presentation, reknowned speaker and author Ginny Redish teaches attendees to think about web content and web writing in new ways. Starting from the premise that every visit to your website is a conversation started by the site visitor, the presentation demonstrates for attendees why people skim and scan, provides a better understanding of when people do read online and when they don't, and reviews a few basic best practices on how to write for the busy people who come to your website.
People come to websites for the content. They come to fulfill a need, to do a task, to get the answer to a question. Clear navigation, good design, and search engines that work are all critical, of course, but they are all there to support the content. Are you paying enough attention to the content on your website – both to what your messages are and to how you are presenting those messages? In this audio conference presentation, reknowned speaker and author Ginny Redish teaches attendees to think about web content and web writing in new ways. Starting from the premise that every visit to your website is a conversation started by the site visitor, the presentation demonstrates for attendees why people skim and scan, provides a better understanding of when people do read online and when they don't, and reviews a few basic best practices on how to write for the busy people who come to your website.
Monday, February 20, 2012
Conducting Medical Device Studies in the UK
is being presented by Janette Benaddi, CEO, of Medvance and airs on Tuesday, March 6th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.
This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.
The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.
This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.
Tuesday, February 14, 2012
Early Development Considerations for Inhalation Drug Products
is being presented by Dr. Nahed Mohsen, Biomedical Engineering Consultant and airs on Thursday, March 1st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Inhalation drug products are delivered via the lungs by aerosol delivery devices, and are used to deliver therapies to treat local and systemic diseases. The advantages of these products are ease of use and the small doses required to achieve the desired treatment. However, the required dose and efficacy of delivery is highly dependent on various developmental design factors which may not be readily apparent. These include drug formulation, aerosol delivery system, interaction between the formulation and the delivery system, packaging of formulation and delivery system as well as human maneuvering with the delivery system – known as hand-lung coordination. Although an inhalation drug product may be comprised of an approved drug and an approved device, new scientific and technical issues may emerge when the drug and device are combined, packaged or used together.
In this audio conference presentation, our speaker draws upon a case study involving a dry powder drug product to address the scientific and technical challenges raised by inhalation drug product packaging, including selection of the component of the primary packaging and how it affects product performance, safety, effectiveness, and quality of the combination product.
Inhalation drug products are delivered via the lungs by aerosol delivery devices, and are used to deliver therapies to treat local and systemic diseases. The advantages of these products are ease of use and the small doses required to achieve the desired treatment. However, the required dose and efficacy of delivery is highly dependent on various developmental design factors which may not be readily apparent. These include drug formulation, aerosol delivery system, interaction between the formulation and the delivery system, packaging of formulation and delivery system as well as human maneuvering with the delivery system – known as hand-lung coordination. Although an inhalation drug product may be comprised of an approved drug and an approved device, new scientific and technical issues may emerge when the drug and device are combined, packaged or used together.
In this audio conference presentation, our speaker draws upon a case study involving a dry powder drug product to address the scientific and technical challenges raised by inhalation drug product packaging, including selection of the component of the primary packaging and how it affects product performance, safety, effectiveness, and quality of the combination product.
Monday, February 13, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Wednesday, February 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Wednesday, February 8, 2012
Measuring and Improving the Readability of Medical Device User Information
is being presented by Cynthia M. Shalers, Writing, Editing & Design Consultant and airs on Tuesday, February 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
A concise, clearly written, readable user guide can mean the difference between a successful, happy customer and a frustrated, angry, or even endangered one. This audio conference approaches readability in medical-device documentation from two directions. First, our speaker explains how to achieve the reading level required by the FDA, providing attendees with the tools for measuring the reading level and adjusting it editorially. Second, she offers a variety of methods for increasing conciseness and simplicity in medical writing, which can be applied to any level of complexity to improve readability. The presentation also reviews graphical aspects that improve readability, such as the proper use of white space, leading, lists, and sidebars. Throughout the conference, the speaker uses specific examples from her own work and cites the relevant FDA guidance documents.
A concise, clearly written, readable user guide can mean the difference between a successful, happy customer and a frustrated, angry, or even endangered one. This audio conference approaches readability in medical-device documentation from two directions. First, our speaker explains how to achieve the reading level required by the FDA, providing attendees with the tools for measuring the reading level and adjusting it editorially. Second, she offers a variety of methods for increasing conciseness and simplicity in medical writing, which can be applied to any level of complexity to improve readability. The presentation also reviews graphical aspects that improve readability, such as the proper use of white space, leading, lists, and sidebars. Throughout the conference, the speaker uses specific examples from her own work and cites the relevant FDA guidance documents.
Monday, February 6, 2012
Food Industry Update – Responding to an FDA Form 483
is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Thursday, February 23rd, 2012. For more details or to register, please visit our site at www.fxconferences.com
On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.
This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.
On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.
This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.
Thursday, February 2, 2012
Monitoring Device Trials: Findings, Recommendations, Corrective Action Plans
is being presented by JoAnn Tyson, CEO & Senior Clinical and Regulatory Affairs Director, with J. Tyson & Associates and airs on Wednesday, February 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
Monitoring for a medical device trial can present unique challenges related to the complexity of the protocol, data capture tools, site personnel selection and limited oversight of subjects/data or procedures inconsistent with good clinical practices (GCP). However, proper monitoring can allow the sponsor/CRO to identify risks more readily and more clearly.
This audio conference presentation focuses on best practices for monitoring medical device trials, from the essential areas of focus during interim site visits to the proper training of monitors and other clinical personnel to ensure trial objectives are achieved. Our speaker also discusses compliance requirements and corrective action plans, and reviews the necessary steps in preparing for a successful regulatory body inspection.
Monitoring for a medical device trial can present unique challenges related to the complexity of the protocol, data capture tools, site personnel selection and limited oversight of subjects/data or procedures inconsistent with good clinical practices (GCP). However, proper monitoring can allow the sponsor/CRO to identify risks more readily and more clearly.
This audio conference presentation focuses on best practices for monitoring medical device trials, from the essential areas of focus during interim site visits to the proper training of monitors and other clinical personnel to ensure trial objectives are achieved. Our speaker also discusses compliance requirements and corrective action plans, and reviews the necessary steps in preparing for a successful regulatory body inspection.
Wednesday, February 1, 2012
Meeting the Linguistic Requirements for EMA Submissions
is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Tuesday, February 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Subscribe to:
Posts (Atom)