is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Tuesday, April 27th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need 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.
The leader in Continuing Education
Friday, March 12, 2010
Thursday, March 11, 2010
Optimizing Regulatory Compliance Throughout the Drug Development Process
is being presented by Dr. Ruth Ann Lee, Director and Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. and airs on Tuesday, April 20, 2010. For more details or to register, please visit our site at www.fxconferences.com
Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.
This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.
Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.
This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.
Monday, March 8, 2010
Medicare Coverage of Clinical Trials: Opportunities & Obstacles
is being presented by Dr. Edward Berger, Larchmont Strategic Advisors and airs on Wednesday, April 14, 2010. For more details or to register, please visit our site at www.fxconferences.com
Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.
This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.
Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.
This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.
Thursday, March 4, 2010
Periodic Safety Update Reports: Be Compliant and Cost Effective
is being presented by Dr. Hemendra Misra & Mark Nelson Tyrrell, with PRA International and airs on Tuesday, March 23, 2010. For more details or to register, please visit our site at www.fxconferences.com
Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).
Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.
Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).
Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.
Wednesday, March 3, 2010
Medical Device Vigilance Planning under the Revised MDD
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Tuesday April 13, 2010. For more details, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.
This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.
This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
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