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.
Showing posts with label David Kern. Show all posts
Showing posts with label David Kern. Show all posts
Thursday, May 12, 2011
Thursday, April 14, 2011
Quality Systems and Design Control for IVD Products
is being presented by David Kern, Senior Director, Myraqa, RAC MBA and airs on Tuesday, May 31st, 2011. For more details, or to register please visit our site at www.fxconferences.com
The concept of quality systems and design control has been around for over 15 years. Implementing a good quality system correctly is not only required for regulatory compliance, but it makes good business sense as well. However, for many companies, and especially small companies, implementing a system that doesn’t create stifling bureaucracy can be a real challenge. How and when a company implements a quality system can mean the difference between long-term success and a slow, painful path to market..
This audio conference presentation looks at the issue of implementing a quality system and design control for in vitro diagnostics, helping attendees to better understand the steps and components in the process, as well as the benefits of getting it right.
The concept of quality systems and design control has been around for over 15 years. Implementing a good quality system correctly is not only required for regulatory compliance, but it makes good business sense as well. However, for many companies, and especially small companies, implementing a system that doesn’t create stifling bureaucracy can be a real challenge. How and when a company implements a quality system can mean the difference between long-term success and a slow, painful path to market..
This audio conference presentation looks at the issue of implementing a quality system and design control for in vitro diagnostics, helping attendees to better understand the steps and components in the process, as well as the benefits of getting it right.
Tuesday, March 22, 2011
Companion Diagnostics - What Pharma Needs to Know About IVDs
is being presented by David Kern, Senior Director, RAC MBA and airs on Wednesday, April 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com
If you are contemplating a companion diagnostics program, or if you already have such a program in place, you need to live in both the drug and diagnostic worlds. One key component to securing FDA approval – and staying in compliance – is understanding how in vitro diagnostics are regulated. Is your test a 510(K) or a PMA? What is the difference between an LDT and an IVD? Does FDA care about ISO standards and certification? This audio conference presentation reviews the current regulatory landscape for IVD tests, as well as lab-developed tests and companion diagnostics, focusing on the things pharma companies need to know.
If you are contemplating a companion diagnostics program, or if you already have such a program in place, you need to live in both the drug and diagnostic worlds. One key component to securing FDA approval – and staying in compliance – is understanding how in vitro diagnostics are regulated. Is your test a 510(K) or a PMA? What is the difference between an LDT and an IVD? Does FDA care about ISO standards and certification? This audio conference presentation reviews the current regulatory landscape for IVD tests, as well as lab-developed tests and companion diagnostics, focusing on the things pharma companies need to know.
Subscribe to:
Posts (Atom)