Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development, the question arises as how to interpret the data.
The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range), and from this range, defining the probability of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approach embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation was presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, with Covance Central Laboratory Services and aired on 2009-01-28. For more details or to download this event, please visit our site at www.fxconferences.com

Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details or to download this event, please visit our site at www.fxconferences.com

Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com

Best Practices for Creating & Translating Global Content

Today, life sciences companies are experiencing tremendous pressure from regulatory bodies to conform to mounting numbers of industry standards. At the same time, they must always look to improve cost and time efficiencies and maintain the highest levels of quality and safety. All of these pressures present a daunting challenge for companies who then need to translate and localize critical information into multiple languages around the world. They can no longer rely on paper-based, manual business processes that are time consuming and error prone. Fortunately, new technologies are revolutionizing the functionality of translation management systems, improving a company's ability to manage and translate information into multiple languages through a set of seamless business processes and best practices.

In this presentation, we discuss globalization best practices to help your organization scale your global reach, growing your business and your bottom line.

Best Practices for Creating & Translating Global Content was presented by Steve Billings & Bill Rabkin, Idiom Technologies and aired on 2007-11-29. For more details or to download this event, please visit our site at www.fxconferences.com

Asian Clinical Trials: What to Know Before You Go

Thinking of conducting clinical trials in Asia?

Certainly more and more pharmaceutical companies are, and with good reason. The predominantly secondary healthcare environment, treatment-naïve patients and large population can mean less time to recruit and faster clinical development. Data quality is high, there are fewer competing studies, and the presence of large hospitals means more patients per site and dramatically reduced trial costs. But jumping on the Asian bandwagon without the proper forethought and knowledge could turn your trial into a tribulation.

Asian Clinical Trials: What to Know Before You Go was presented by Anthony Bishop, Quintiles East Asia and aired on 2004-07-27. For more details or to download this event, please visit our site at www.fxconferences.com