Wednesday, November 11, 2009

Risk, Reward and the Pharmaceutical Life Cycle


Despite all the recent news about job cuts and lay offs, are you still interested in a non-clinical career in pharmaceutical medicine? Then you may be interested to know that there's another free live webcast coming up: "Risk, Reward and the Pharmaceutical Life Cycle: Managing Information as a Strategic Asset"

Live Webcast: December 2, 2009 at 11:00 AM EST
REMS, RMPs, RiskMAPS, the Sentinel Initiative and other FDA programs geared to identifying product safety risks before they emerge as public health challenges raise the bar on what the sponsors must do to comply. These include making significant investments in upgrading the quality and scope of surveillance data to track the impact of a medicine’s use on the patient community at every stage of its life cycle, from clinical trials to post marketing surveillance – in the latter case, this can now include obligations to monitor safety and risk well beyond the time of patent expiry.

In this new regulatory environment, relevant information must be accessible for analysis and reporting to meet strict regulatory time frames. In addition, the method of sharing this information with external parties must have controls in place to ensure the confidentiality of what, for knowledge-based industries like pharmaceuticals, is a key strategic asset. Technology such as configurable web-based exchange platforms can make this process more efficient by standardizing document distribution on a global basis, while adding a layer of control and reporting capabilities.
Key Learning Objectives :
• Learn how an understanding of regulatory methodology can facilitate rapid responses to safety queries
• Learn how web-based repositories and document distribution can facilitate access and submission of time-sensitive adverse event analyses and reports
• Understand how to quantify the time and money savings realized by moving your safety document distribution process online
Speakers:
Christopher Milne, PhD, DVM
Deputy Director and Lead Policy Advisor
Tufts University Center for the Study of Drug Development

Gail Farfel, PhD
GM Group Consulting

Robert Reynolds
Senior Director, Drug Safety and Regulatory Affairs
Pfizer, Inc.

Allison Shurell
Vice President, Product Marketing
IntraLinks
To register for this event, click here.

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