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.
Monday, March 8, 2010
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.
Tuesday, March 2, 2010
Building Better Clinician Relationships
is being presented by Clair Callan, CEO and Founder, of Callan Consulting and airs on Tuesday, April 8, 2010. For more details or to register, please visit our site at www.fxconferences.com
The health care environment is in a state of flux, and hospitals and physicians must deal with constant change and a variety of other challenges in meeting their goal of providing the best patient care possible. The good news for drug and device companies is that there exist within this climate opportunities for expanding and strengthening the relationships between clinicans and industry. Life sciences companies can add value by providing information and training sessions, ideas for expanded use of products within the scope of regulatory approval, and advice on how to get approval for expanded use of already approved technology.
In this audio conference, attendees learn ways in which they can capitalize on the current health care environment to further develop their clinican relationships, how this benefits both doctors and their patients, and why it simply makes good business sense.
The health care environment is in a state of flux, and hospitals and physicians must deal with constant change and a variety of other challenges in meeting their goal of providing the best patient care possible. The good news for drug and device companies is that there exist within this climate opportunities for expanding and strengthening the relationships between clinicans and industry. Life sciences companies can add value by providing information and training sessions, ideas for expanded use of products within the scope of regulatory approval, and advice on how to get approval for expanded use of already approved technology.
In this audio conference, attendees learn ways in which they can capitalize on the current health care environment to further develop their clinican relationships, how this benefits both doctors and their patients, and why it simply makes good business sense.
Monday, March 1, 2010
New audio conference website is now live
Over the past 8+ years, ForeignExchange's dedicated audio conference team produced hundreds of events for thousands of attendees. This effort has become an important educational tool for ForeignExchange, our clients, and our suppliers.
Our team continually improves the usability of FxConferences.com, the web site for our audio conference program, and we are happy to announce that a major site redesign has just been successfully completed.
The new FxConferences.com features a substantially improved user interface. Event information is better laid out - from the results list to the event abstracts themselves. FxConferences.com now provides streamlined information in a central location.
Here are the main changes and improvements that we made (for comparison, take a look at our old audio conference site) :
- The search functionality is much deeper, creating advanced search capabilities and better industry and department-specific yields.
- The results of your searches are highly sortable, enabling users to list titles by date, name, department, or industry.
- The new site is aesthetically more pleasing - it looks really great!
- Users have much better access to other audio conferences by the same speaker or company.
ForeignExchange produces almost-daily audio conferences around regulatory, clinical, quality, financial, and medical translation topics. Visit us at FxConferences.com to learn more.
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