is being presented by Gina Ross, , Director, Quality Document Systems Management, with Beckloff Associates and airs on Tuesday, Novemeber 30th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
A sound regulatory strategy, combined with proactive lifecycle management of electronic submissions, can speed the regulatory review and approval process and reduce the regulatory burden, expand marketing applications to additional jurisdictions and drive successful regulatory approval outcomes.
To be truly successful at integrating regulatory strategy and eCTD lifecycle management, sponsors need to evaluate their existing document authoring and submission compilation activities and determine what, if any, modifications are necessary to accommodate the eCTD specifications. Document authors need to understand not only the CTD guidelines, but also have a working knowledge of the eCTD guidelines and application of the lifecycle operation attributes. Regulatory affairs and regulatory operations (i.e. publishers) need to have an in-depth knowledge of the CTD and eCTD guidelines, as well as the electronic requirements of multiple global regulatory agencies.
This audio conference is designed to help organizations and individuals understand the relationship between regulatory strategy and the eCTD lifecycle management, and to effectively develop systems, processes and procedures to support the chosen strategies and facilitate the future lifecycle management of applications.
Monday, October 25, 2010
Tuesday, October 19, 2010
eLabeling for Medical Devices in the EU
is being presented by Joachim Wilke, Director, Regulatory Affairs & Policy, Europe
, with Medtronic and airs on Wednesday, November 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Get the very latest on European device labeling, from one of the architects of the legislation!
This audio conference discusses the background and status of the upcoming legislation on elabeling for medical devices in the European Union. Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for elabeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. Our speaker, who chairs Eucomed's Alternative Labeling Task Force, also reviews a number of topics still under discussion, and provides information about the political process and expected time scenario – as well as factors which could lead to potential delays. The presentation also raises some practical considerations on the implementation of elabeling for medical devices.
, with Medtronic and airs on Wednesday, November 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Get the very latest on European device labeling, from one of the architects of the legislation!
This audio conference discusses the background and status of the upcoming legislation on elabeling for medical devices in the European Union. Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for elabeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. Our speaker, who chairs Eucomed's Alternative Labeling Task Force, also reviews a number of topics still under discussion, and provides information about the political process and expected time scenario – as well as factors which could lead to potential delays. The presentation also raises some practical considerations on the implementation of elabeling for medical devices.
Friday, October 15, 2010
Academic Medical Centers and Clinical Research Productivity: How to Choose The Best Sites
is being presented by Anita S. Kablinger, Physician, Carilion Clinic
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?
This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?
This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.
Thursday, October 14, 2010
3 Steps to Successful Translation Management
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Tuesday, November 23rd, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Wednesday, October 13, 2010
Part 11 Compliance and CDER Tag-Along Inspections - Are You Ready?
is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, Novemeber 11th, 2010. For more details or to register, please visit our site at www.fxconferences.com
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
Subscribe to:
Posts (Atom)