BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Sunshine Act
Overview of Physician Payments "Open Payments Program" (Sunshine Act), which requires manufacturers of drugs, medical devices/ biologicals that participate in U.S. federal health care programs to report certain payments/items of value given to physicians/teaching hospitals.
Takeaways
The Physician Payments “Open Payments Program (Sunshine Act) requires manufacturers of drugs, medical devices/ biologicals that participate in U.S. Federal Health Care Programs to report certain payments/items of value given to physicians/teaching hospitals
It’s important to understand the Sunshine Act’s key terminology, basic standards, definition of marketing and exceptions, penalties and fines, and privacy and security considerations for e-customer base
The Sunshine Act is very detailed and covers certified medical education, considerations for tracking spend at meetings; covered entities and recipients; data entry considerations; dispute period; Federal preemption and state laws; Information to track; Payments for Transfers of Value (POTV)
A first-time CEO's playbook to empower you to navigate the commercialization journey effectively.
Explore drug approval process for small molecules & biologics: regulatory bodies, application process, preclinical to clinical studies, final approval.
Explore cGMP benefits & challenges. Learn about pillar requirements: QMS, Premises, Personnel, Materials, Documents, Validation. Understand audits & remediations with case studies.
Learn about AAV viral vector platforms, Triple Transient Transfection, upstream & downstream bioprocessing, packaging, & CMC regulatory aspects.