Emeryville, CA (PRWEB) May 10, 2011
BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its President and Chief Executive Officer, Sally Van Doren, PharmD, will present “FDA Final Rule on IND Safety Reporting: Impact to Your Clinical Studies”. The FDA announced changes to the regulations on IND safety reporting, which went into effect on March 28, 2011.
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. The 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 new rule requires that certain safety information now be reported within 15 days of becoming aware of an occurrence. These reports include findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions that occur at a rate higher than described in the IB; and SAEs from bioavailability and bioequivalence studies.
Along with this final rule, the FDA issued a draft guidance for industry and investigators that provides information and advice about the new requirements. Dr. Van Doren will review how these regulatory changes may impact your ongoing and future clinical trials.
The presentation will take place Thursday, June 2, 2011, 3:30 – 5:00 PM at the UCSF, Mt. Zion Campus, 1600 Divisadero, B-248, Herbst Auditorium (2nd floor), San Francisco. The event is free to both members and non-member. To RSVP contact Ilana Hettena, CCRP, hettenai(at)cc(dot)ucsf(dot)edu.
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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