Emeryville, CA (Vocus/PRWEB) March 15, 2011
BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its President and Chief Executive Officer, Sally Van Doren, Pharm D, will lead a FREE webinar, “FDA Final Rule on IND Safety Reporting: Impact to your Clinical Development Programs” on Tuesday, March 22, 2011, 9-10am Pacific Time.
The webinar is a follow-up to BioSoteria’s recently released white paper, "FDA Final Rule: IND Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans".
This final rule which codifies the FDA's expectations for timely review, evaluation, and submission of relevant and useful safety information of drug and biologic products subject to an investigational new drug (IND) application. This final rule amends parts 312 and 320 of FDA regulations by revising the requirements for IND safety reporting and for bioavailability and bioequivalence studies. The IND regulation changes involve clarification of several definitions, what safety information to report and when (including additional safety information required for expedited reporting) and various other clarifications related to IND safety reporting. The effective date for the final rule is March 28, 2011. Sign up for this FREE webinar by going to http://biosoteria.com/training-and-education/webinars.html and learn how the new regulation impacts your clinical development program.
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.
# # #