The Sunshine Act Reporting for Clinical Trials
Duration: 60 Minutes
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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. This seminar will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting. This seminar would also assist sponsors and investigators to develop standard practices to meet federal requirements.
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 seminar 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.
Objectives of the Presentation:
This webinar will provide valuable information to:
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Download AgendaWhy 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 seminar 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.
Objectives of the Presentation:
- 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 investgators
- Regulatory solutions for most common anticipated issues with reporting.
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 for companies developing new products for US market
- Regulatory affairs professionals, research analysts
- Financial analysts and investors, venture capitalists, insurance professionals
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.
Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.
Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.
Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".
Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.
Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.
Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.
Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".
Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
View More