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Online Webinar on FDA's Guidance on Financial Disclosure by Clinical Investigators in September

Online Webinar on FDA's Guidance on Financial Disclosure by Clinical Investigators in September

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09/21/2016 - 09/21/2016

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Add to Your Calendar 09-21-2016 00:00:00 09-21-2016 00:00:00 11 Online Webinar on FDA's Guidance on Financial Disclosure by Clinical Investigators in September Overview: This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators. Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests. Areas Covered in the Session:Review 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 interests Who Will Benefit: The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including:Regulatory AffairsClinical AffairsInvestigatorsQuality and ComplianceMarketing & Sales Distributors/Authorized RepresentativesLegal CounselConsultants Speaker Profile:David R... Compliance4all true MM/DD/YYYY

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Event Manager
Compliance4all
161 Mission Falls Lane, Suite 216
Fremont, CA
(800) 447-9407

Event Description

Overview:
This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.

Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests.

Areas Covered in the Session:
Review proposed changes to the 2011 released draft guidance
Clarification on definition of sponsor
Understand FDA’s clear actions that can and will be taken regarding refuse to file a marketing application
Learn how to submit financial disclosure information to FDA
Why FDA is expounding on due diligence and its significance
Timing of data collection and purpose
Understand how financial information should be disclosed to FDA
Update regarding financial disclosure questionnaires
Time period covered by regulations
Clarification on covered clinical study
Factors for FDA review of disclosed financial interests

Who Will Benefit:
The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding with FDA’s draft guidance on financial disclosure by clinical investigators, including:
Regulatory Affairs
Clinical Affairs
Investigators
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Legal Counsel
Consultants

Speaker Profile:
David R. Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/2aa1gix
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Event Details

Website: http://bit.ly/2aa1gix...
Conference/Event Dates: 09/21/2016 - 09/21/2016
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Education Events
Other Industries: Education, Education Events
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: One Dial-in One Attendee

Price: US$150.00
Number of Exhibitors:1
Show Owner:18004479407
Show Manager:Event Manager
Exhibitor Prospectus:Click Here

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Online Webinar on FDA's Guidance on Financial Disclosure by Clinical Investigators in September

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