Friday, November 27, 2009

Risk, Reward and the Pharmaceutical Life Cycle


There's another free live webcast coming up titled, "Risk, Reward and the Pharmaceutical Life Cycle."
Managing Information as a Strategic Productivity Asset
Live Webcast: December 2, 2009 at 11:00 AM EST
This is an industry-sponsored event and is NOT a certified CME/CE activity. If you'd like to learn more about the pharmaceutical industry, then you may want to participate in this event.

Here's a summary:
Major changes are underway in the reporting and enforcement environment for drug safety, with new regulations now in place in the US and Europe that require sponsoring companies to provide timely, comprehensive and accurate information to authorities, virtually on demand. 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 and customized resource platforms can make this process more efficient by standardizing document distribution on a global basis, and allowing the detailed analysis demanded in sensitive areas like adverse event reporting.
Key Learning Objectives:
  • Learn how an understanding of regulatory methodology can facilitate rapid responses to safety queries
  • Learn how web-based document exchange platforms can facilitate access, distribution and submission of time-sensitive adverse event reports
  • Understand how to quantify the time and money savings realized by moving your safety document distribution process online
Chat Live with a Panel of Experts:

1. Christopher Milne, PhD, DVM, Deputy Director and Lead Policy Adviser, Tufts University Center for the Study of Drug Development

2. Gail Farfel, PhD, G Meredith Consulting, LLC

3. Dr. Jingping Mo, MD PhD, Senior Director, Epidemiology, Safety and Risk Management, Pfizer Inc.

4. Alison Shurell, VP, Life Science Product Marketing, IntraLinks

Click here to register for this free event.

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