NEW YORK, April 7, 2003 (PRIMEZONE) -- As the amount of time it takes the FDA to approve new drug applications has increased over the past several years, as well as the situation of fewer new drugs entering the market, pharmaceutical companies are actively seeking ways to reverse these trends by taking a closer look at Regulatory Intelligence, a relatively new function within the pharmaceutical industry.
Christopher J. Webster, Director of Regulatory Strategy and Intelligence for Millennium Pharmaceuticals Inc., explained: "Regulatory Intelligence' is strategic knowledge of the regulatory environment that enables drug or device sponsors to obtain prompt and efficient approvals of new products or product attributes with ideal labels."
Webster along with other leading regulatory affairs professionals will be addressing some the most critical regulatory issues at The Institute for International Research's conference "Regulatory Intelligence: Achieving Global Regulatory Strategic Success" being held April 28-29, 2003, at the Hilton Alexandria Mark Center in Alexandria, Virginia. This forum provides insight for those working within regulatory affairs, competitive intelligence, information resources, business intelligence, global intelligence, and library services. To register, call (888) 670-8200 or visit www.iirusa.com/regulatoryintelligence. Mention Priority code: XMNEWS
"Regulatory intelligence capabilities are a critical component of any regulatory affairs department," according to Elizabeth Fenna, Director of Regulatory Affairs for ClinQuest, Inc. "Lack of these capabilities can expose your company to risks of non-compliance, may jeopardize the timely execution of developmental and commercial plans, and hamper efforts to effectively work with regulatory authorities."
Essentially, Regulatory Intelligence involves a three-step process:
- Gathering the most up-to-date regulatory information available for the U.S. and international markets - Analyzing the impact of regulatory information on your company, your competitors and particular projects (converting 'information' to 'intelligence') - Disseminating regulatory intelligence to appropriate decision-makers, e.g., therapy area head, project manager, etc.
Regulatory intelligence is proving to be more than nice to have -- but rather, it is becoming essential. "Practicing regulatory affairs without regulatory intelligence is like driving a car with a blind-fold on," Fenna added. "Proceed at your own risk!"
Delegates are expected to benefit from hearing 2 days of keynote presentations from representatives of Astra-Zeneca ClinQuest, Genzyme, Hoffman-LaRoche, Millenium, Novartis, Pfizer, Inc., Pharmacia, Sanofi-Synthelabo and Sopheon.
This Event Is Open For Registration. For More Information and to register, call (888) 670-8200 or visit www.iirusa.com/regulatoryintelligence
Mention Priority Code: XMNEWS
About IIR
The Institute for International Research (IIR) is the world's leading knowledge and skills transfer company with a global network of 44 companies and 109 operating units. IIR works with more than 60,0000 business executives annually, providing them with the knowledge and skills through training, conferences, seminars, e-learning, blended solutions, publications, exhibitions, consulting and mentoring. Visit www.iir-global.com for more information.