The Sunshine Act Reporting for Clinical Trials

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

Understand the Sunshine Act Reporting Requirements for Clinical Trials or Face Hefty Fines

The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail, non-compliance to which would lead to hefty fines.

Understand the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators with our expert Dr Mukesh Kumar. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements, and timelines for compliance and enforcement will be discussed in this session.

Dr. Kumar will discuss the details of the processes for reporting to CMS; provide templates for reporting formats; and timelines for reporting. Plus, this session would also assist sponsors and investigators to develop standard practices to meet federal Sunshine act reporting requirements.

Here are a few highlights of the session:

  • Clinical trial financial reporting requirements
  • Kind of payments covered and exempted for reporting to CMS
  • Format of reporting to CMS
  • Dealing with CMS's inquiries regarding reported information
  • Acceptable and unacceptable practices
  • Comparison of Federal reporting requirements with industry best practices
  • Legal and practical implications of reporting financial information for investigators
  • Regulatory solutions for most common anticipated issues with reporting

Who should attend?

  • Principal and co-Investigators participating in industry-sponsored clinical trials
  • Sponsors of clinical trials
  • Legal experts involved in assisting physicians and patients alike with medical malpractice
  • Medical accounting companies
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals, research analysts
  • Financial analysts and investors, venture capitalists, insurance professionals

Order Below or Call 1-866-458-2965 Today

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1-866-458-2965

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1-919-287-2643

About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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