Leveraging the Benefits of eMDR (Electronic Medical Device Reporting)

Inefficient medical device reporting presents a clear and present danger: It can damage your company’s reputation and even threaten your ability to operate. After sending some mixed signals in the second half of 2007, FDA eMDR experts have said they’ll mandate eMDR within two years. The only debate now is how quickly it will happen, and what kind of timeline mandate will be imposed.

It’s therefore not surprising to learn the agency is pushing harder for eMDR (electronic medical device reporting) than anyone else. By attending this audio conference, you'll learn more about the future of eMDR, the options available to you now, and why it makes good business sense to implement an electronic medical device reporting system today.

Leveraging the Benefits of eMDR (Electronic Medical Device Reporting) is presented by Tamar June, Vice President of Strategic Marketing, of AssurX. This audio conference airs on Wednesday, December 10th, 2008, for more details or to register, please visit our site www.fxconferences.com

International Sponsor-CRO Relationships: A Legal View

An ever-present issue for sponsor companies is whether to partner with a Clinical Research Organization. From that follows questions and strategies on how to best select a CRO and manage the relationship. The process takes on added dimension when conducting research internationally.

In this presentation, the speaker highlights key contract and relationship issues and the recurrent problems that arise within these relationships, and also offer practical, experience-based tips for maximizing the relationship's value and efficiencies. We discuss the difference between partner and vendor, and contract versus relationship. The presentation also examines local vs. U.S.-based CROs, and how to assess a CRO's experience and ability to comply with local rules and regulations and FDA requirements, as well as cooperating with the sponsor and other participating CROs.

International Sponsor-CRO Relationships: A Legal View was presented by Maria D. Buckley, of Nutter, McLennen & Fish, LLP. This audio conference is available for download at www.fxconferences.com

Recruiting Research Participants Using Web-Based Software

Could the Internet be the key to driving participation in your clinical research? More and more institutions and organizations are successfully using web-based software to recruit larger numbers of research participants for clinical trials and studies. Internet technology can increase recruitment numbers and enrollment, and increase the revenue to the institution when studies are filling with subjects. Anyone with Internet access can get the information they need, register, provide consent, answer a series of questions, and join a pool of potential research participants online.

In this audio conference, our speakers examine how web-based software can make patient recruitment faster and more efficient, and provide real-life examples of the positive results achieved at two leading health care institutions.

Recruiting Research Participants Using Web-Based Software is presented by Marjorie Tharp, mdlogix and Charles Rathmann, Washington University. This audio conference airs on Thursday, Dec. 11, 2008, for more details, please visit our site www.fxconferences.com

Pharma 2010: The Threshold of Innovation

While some analysts predict the pharmaceutical industry will grow by 9% by the year 2010, IBM Business Consulting Services is anticipating a much lower rate of 5.3%. However, in Pharma 2010: The Threshold of Innovation, IBM predicts that a new business model based on Targeted Treatment Solutions has the potential to achieve breakthrough growth. The authors propose that this new business model is needed to meet the challenge of governments and insurers who are no longer willing or able to pay high prices for "me too" medicines.

This presentation provides an in-depth overview of the "Pharma 2010" strategies that will lead to a more adaptive and flexible way of conducting business and treating patients.

Pharma 2010: The Threshold of Innovation was presented by Sam Barnett, Lead Partner, Life Sciences & Pharma of IBM Business Consulting Services and aired on 2004-06-29 and is available for download at www.fxconferences.com

Moving Target: Animal Tissue Regulations Update

Animal tissues have been utilized in medical devices and pharmaceuticals for many years, but the change in the 'state of the art' has meant an understandable and justifiable increase in the awareness of safety issues.

Directives such as 2003/32/EC and Regulation 1774/2002 have steadily increased the burden on the manufacturer to demonstrate safety. Moreover, additional guidelines from the CVMP/CPMP, monographs from the EDQM, and standards covering viral contamination potentially add to the confusion. Was your medical device product in compliance before the October 2004 deadline? Is the EDQM procedure too much of a challenge?

In this audio conference, Phil Brown looks at the development of -- and explains the differences between -- the Directive, the Regulation and all the other documents, with the aim of providing some clarity.

Moving Target: Animal Tissue Regulations Update was presented on 2005-03-09 and is available for download, for more details please visit our site www.fxconferences.com