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FDA's 2011 Guidance on Financial Disclosure by Clinical Investigators

An overview on FDA guidance to firms going through clinical trial training and working with clinical investigators.

OverviewThis webinar will provide an overview and FDA guidance to firms that are either going through or preparing to go through clinical trial training and working with clinical investigators.In Spring 2011, FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigator training. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests. Consistent with increased public attention to physician-industry ties and connections, the tone of the guidance suggests or infers that clinical trial sponsors should expect a more rigorous review by FDA of these financial arrangements.Why Should You AttendThis Webinar highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure regulations to be submitted in the marketing applications to FDA. The financial disclosure regulations in 21 CFR 54 are designed to help uncover potential investigatory bias that may arise due to financial arrangement between the investigator and the clinical trial sponsor.Areas Covered in this WebinarThis Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the "draft" offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDA's current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.Learning ObjectivesReview proposed changes to the 2011 released draft guidanceClarification on definition of sponsorUnderstand FDA's clear actions that can and will be taken regarding refuse to file a marketing applicationLearn how to submit financial disclosure information to FDAWhy FDA is expounding on due diligence and its significance Timing of data collection and purposeUnderstand how financial information should be disclosed to FDAUpdate regarding financial disclosure questionnaires Time period covered by regulationsClarification on covered clinical studyFactors for FDA review of disclosed financial interestsWho Will BenefitRegulatory Affairs PersonnelClinical Affairs PersonnelInvestigatorsQuality and Compliance ProfessionalsMarketing & Sales ProfessionalsDistributors/Authorized RepresentativesLegal CounselConsultantsLevelBeginner


16 Feb 2016 @ 01:00 pm

16 Feb 2016 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar



Organised by

Compliance Global Inc (deactivated)

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