is being presented by Kevin McCabe & Dr. Eldora Ellison, Directors, Biotechnology/Chemical and Litigation Groups Sterne, Kessler, Goldstein & Fox P.L.L.C. and airs on Tuesday, June 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Sooner or later, nearly all high technology companies encounter one or more patents that may present a roadblock to bringing a product to market or to conducting important research.
This audio conference presentation provides an overview of the legal tools available in the United States to help address such “problem” patents. In particular, our speakers provide a detailed discussion of patent re-examinations and the interplay between re-examinations and litigation. Additionally, the presentation looks at other mechanisms that may be used when one encounters a problematic patent, such as licensing, design-arounds, protests, interferences, and arbitration.
This presentation is informative both for companies that are concerned with patents held by others, as well as companies that may seek to enforce their own patents and thus subject such patents to validity challenges. The knowledge of these tools, and their various pros and cons, provided through this presentation give companies needed information to assist their strategic decision-making.
Tuesday, May 24, 2011
Friday, May 13, 2011
Navigating China's Medical Device Regulations
is being presented by Chang-Hong Whitney, MBA, RAC, President, Whitney Consulting Ltd. and airs on Thursday, June 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com
China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.
China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.
Thursday, May 12, 2011
Alliance Management - Bridging the Gap Between Drugs and Diagnostics
is being presented by David Kern, RAC MBA, Senior Director, Myraqa and airs on Tuesday, July 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Alliance management has long been a core competency in many drug companies, as a way of helping to ensure that compounds discovered by biotech partners make their way to the market. Yet the relationship between drug and diagnostics companies has been a challenge for both sides. Understanding how to manage these strategic relationships is critical to the successful development of a companion diagnostic test, and there can be consequences for a drug company not taking an active role in these alliances.
In this audio conference presentation, our speaker examines the issue, and discusses when and how to start looking for a diagnostics partner, how to structure the relationship, and how best to work together for mutual benefit.
Alliance management has long been a core competency in many drug companies, as a way of helping to ensure that compounds discovered by biotech partners make their way to the market. Yet the relationship between drug and diagnostics companies has been a challenge for both sides. Understanding how to manage these strategic relationships is critical to the successful development of a companion diagnostic test, and there can be consequences for a drug company not taking an active role in these alliances.
In this audio conference presentation, our speaker examines the issue, and discusses when and how to start looking for a diagnostics partner, how to structure the relationship, and how best to work together for mutual benefit.
Wednesday, May 11, 2011
Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Wednesday, June 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
Tuesday, May 10, 2011
FDA on the Edge: What's Next for 510(k)?
is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, June 2nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.
For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.
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