This is particularly timely in light of the new FDA Final Rule on IND Safety Reporting which was announced end of September 2010 and becomes effective March 28, 2011.
Emeryville, CA (Vocus) October 19, 2010
BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its President and Chief Executive Officer, Sally Van Doren, PharmD, will speak about the “Determination of Adverse Event Expectedness”. Her presentation will include late breaking information on the FDA Final Rule on IND safety reporting and how this new regulation impacts study sponsors. Her presentation will take place at the MAGI Clinical Research Conference - 2010 West on October 25, 2010 from 1:30 PM – 2:45 PM at The Fairmont, San Francisco. “This is particularly timely in light of the new FDA Final Rule on IND Safety Reporting which was announced end of September 2010 and becomes effective March 28, 2011,” said Dr. Van Doren.
MAGI serves over 5,000 members which represent clinical research sponsors, sites, and contract research organizations (CROs). Their objective is to standardize best practices for clinical research operations, business and regulatory compliance.
Founded in 2007 with a strong vision of a progressive drug safety and pharmacovigilance consulting services and education, BioSoteria serves the outsourcing needs of the pharmaceutical industry. From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise, and leadership to support your company’s efforts to maximize your product’s benefit-risk profile. For more information and to learn more about BioSoteria’s drug safety services and training programs, go to http://www.biosoteria.com.
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