Studies in Special Patient Populations: More than Just a Regulatory Requirement

In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Navigating State Sales & Marketing Laws for Drugs & Medical Devices

Marketing your pharmaceutical product or medical device while adhering to ever-changing state and federal laws can pose a signifcant challenge. For example, on March 11, 2009 the Massachusetts Department of Public Health issued requirements similar to those of other states, imposing restrictions on pharmaceutical and medical device manufacturers’ sales and marketing activities. This session looks at current state laws regulating the sales and marketing practices of pharmaceutical, biotech and medical device companies, with a particular emphasis on the new requirements in Massachusetts and Vermont.

In this conference, our speaker examines the federal legislation that regulates pharmaceutical and medical device sales and marketing, while also providing insight into how companies can develop compliance plans to take into account the "patchwork" of state laws, applicable federal laws and industry guidance.

Navigating State Sales & Marketing Laws for Drugs & Medical Devices is being presented by Maria D. Buckley, with Nutter McClennen & Fish LLP and airs on Wednesday, November 4, 2009. For more details or to register to attend this event, please visit our site at www.fxconferences.com

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees

Even when employee benefits material is well translated and presented in Spanish, many companies find that Spanish speakers are still reluctant to participate and instead opt out of very valuable opportunities for health coverage, retirement plans, etc. This tendency is frustrating to HR professionals, brokers and benefits providers who have invested putting together a Spanish presentation.

This discussion addresses misconceptions Spanish speakers commonly hold about insurance and finance in this country and present practical and cost-effective strategies for conducting effective enrollment meetings and maximizing participation among Spanish speakers in benefit plans.

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees was presented by Melissa Burkhardt, President, of Futuro Sólido and aired on 2008-05-28. For more details on this conference, or to download it please visit our site at www.fxconferences.com

Adaptive Trial Design: Streamlining the Clinical Supply Process

Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.

From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).

Adaptive Trial Design: Streamlining the Clinical Supply Process was presented by Geert Langendries, with Covance IVRS Project Management Group and aired on 2007-12-05. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Designing Web Sites for International Users

When it comes to building and maintaining international Web sites, many companies suffer from an English-centric world view. Neglecting global markets with your site, means you risk alienating potential customers and forgoing revenue opportunities. Whether your company is international "from the ground up" or selling products into select markets, it can benefit from a well-implemented global Web strategy.

This audio conference helps you successfully manage the daunting task of designing and maintaining a high-quality international Web presence.

Designing Web Sites for International Users was previously recorded and presented by Andres Heuberger, President, of ForeignExchange Translations. For more details, or to download this conference please visit our site at www.fxconferences.com