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:
Who should attend?
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 Events By The Speaker