Integrated Regulatory and Reimbursement Pathways for Commercial Acceleration
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Event Details
Drug/Therapeutic, Medical Device, Diagnostic and Health Software or Service Companies face unique challenges in today's climate for achieving both regulatory confirmation/clearance/approval as well as revenue attainment or reimbursement. This webinar will focus on strategies for efficiently achieving BOTH (and in cost-effective, integrated ways).
Topics covered:
- Regulatory-body (US and OUS) and both CMS, OUS government & corporate insurer contrasting viewpoints on healthcare economics, quality and value
- Overview of revenue generation strategies
- Information on the intersection between commercialization, regulatory timeframes, and reimbursement
- Regulatory pathways and FDA updates including ISO13485/GMP Compliance (Harmonization with 21 CFR 820)
- Types of reimbursement and information on codes/coding, coverage, and actual payment
- Common pitfalls, how to avoid them and Q&A.
Lindsay Klee is the Founder of Intent Venture Management LLC and advises investors, life science, medtech, and healthcare clients nationwide. With extensive experience in regulatory strategy, reimbursement planning, clinical trial readiness, and funding initiatives, she has led multi-million-dollar innovation programs and supported startups, payors, and global manufacturers. A former scientist at Pfizer, Lindsay holds a master’s degree in healthcare management with a finance focus from the University of Michigan.