The Sunshine Act Reporting for Clinical Trials

Why Should You Attend:

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

This webinar will summarize the new requirements 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 reporting requirements, and time-lines for compliance and enforcement will be discussed. This webinar would also assist sponsors and investigators to develop standard practices to meet federal requirements.

Areas Covered in the Webinar:

• 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 requirements

Who Will Benefit:

This webinar will provide valuable information to

• 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 of companies developing new products for US market
• Regulatory affairs professional and research analysts
• Financial analysts and investors, venture capitalists, and insurance professionals

Instructor Profile:

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. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in over 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar has conducted numerous training workshops in 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 in several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and is a regulatory affairs professional certified by the Regulatory Affairs Professional Society, USA.

Topic Background:

Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare. Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicaid Services (CMS). These disclosures are in addition to the financial disclosure requirements to the FDA under IND regulations. Sponsors are required to collect detailed financial information and report to the CMS, which will verify it with the investigators, after which the information about each individual investigators will be made available on CMS’s website to general public. Non-compliance could subject both the sponsors and investigators participating in clinical trials to hefty fines.

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