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DTSTAMP:20260526T194937Z
SUMMARY:The Sunshine Act Reporting for Clinical Trials
DESCRIPTION:This webinar will discuss the disclosure requirements for 
 clinical investigators under the Sunshine Act. It will discuss the det
 ails of the processes; provide templates for reporting formats; and ti
 melines for reporting.\n\nWhy Should You Attend:\nThe Sunshine Act exp
 oses the physicians and sponsors to new reporting requirements which a
 re unprecedented in their scope and detail noncompliance to which woul
 d lead to hefty fines.\nThis webinar will summarize the new requiremen
 ts and provide practical solutions to most common situations that are 
 prevalent and necessary between sponsors and investigators. Templates 
 for reporting format, acceptable accounting practices, exemptions to r
 eporting requirements, and time-lines for compliance and enforcement w
 ill be discussed. This webinar would also assist sponsors and investig
 ators to develop standard practices to meet federal requirements.\nAre
 as Covered in the Webinar:\n\nClinical trial financial reporting requi
 rements\nKind of payments covered and exempted for reporting to CMS\nF
 ormat of reporting to CMS\nDealing with CMS’s inquiries regarding re
 ported information\nAcceptable and Unacceptable practices\nComparison 
 of Federal reporting requirements with Industry best practices\nLegal 
 and practical implications of reporting financial information for inve
 stigators\nRegulatory solutions for most common anticipated issues wit
 h reporting.\n\nWho will benefit:\nThis webinar will provide valuable 
 information to\n\nPrincipal and co-Investigators participating in indu
 stry-sponsored clinical trials\nSponsors of clinical trials\nLegal exp
 erts involved in assisting physicians and patients alike with medical 
 malpractice\nMedical accounting companies\nSenior management for compa
 nies developing new products for US market\nRegulatory affairs profess
 ionals, research analysts\nFinancial analysts and investors, venture c
 apitalists, insurance professionals\n\nInstructor Profile:\nDr. Mukesh
  Kumar, is a Washington DC-based consultant in regulatory affairs and
  quality assurance for manufacturers and developers of FDA-regulated p
 roducts. He and leads the Regulatory Affairs and Quality Assurance dep
 artments at Amarex, a full service pharmaceutical product development 
 company based in Germantown, MD. His key expertise is in regulatory af
 fairs, clinical trials and multi-national project management for medic
 inal and diagnostic products. He has been involved in about 100 clinic
 al trials in more than 40 countries, has made several hundred US FDA s
 ubmissions, and arranged a number of meetings with the US FDA. In addi
 tion, he has had made regulatory submission in the EU and India. He ha
 s conducted GCP, GLP, GMP and GACP audits in the US and several countr
 ies in Europe and Asia. He has conducted numerous training workshops i
 n FDA compliance related issues. He has authored numerous articles in 
 peer-reviewed journals. He is a well known expert in global regulatory
  affairs and has been an invited speaker at several professional and a
 cademic organizations worldwide. Dr. Kumar is a PhD in Biochemistry an
 d has worked as a research scientist at the NIH, Baylor College of Med
 icine, Houston, and premier institutions in India. He is a certified r
 egulatory affairs professional by the Regulatory Affairs Professional 
 Society, USA.\n\nFor more information visit https://medtechiq.ning.com
 /events/the-sunshine-act-reporting-for-clinical-trials
DTSTART;TZID=America/New_York:20131219T100000
DTEND;TZID=America/New_York:20131219T110000
CATEGORIES:online, medical, event
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=702970?channe=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=702970?channe=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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