This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.
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.
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 for companies developing new products for US market
-Regulatory affairs professionals, research analysts
-Financial analysts and investors, venture capitalists, insurance professionals
Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and 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 about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He 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 at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.