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.
Monday, February 13, 2012
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.
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