Learning the new language of the EMA & the FDA: FHIR
Fast Healthcare Interoperability Resources (FHIR) represents a significant step in how we manage and exchange information and is rapidly gaining acceptance.
Join industry experts Mike Baird and Gary Saner as they provide an introduction to the FHIR initiative, explore some current applications as well as the impacts, benefits and prospective timelines.
Plus, you’ll explore the prospective timelines and next steps for FHIR implementations and what it means for the future of healthcare.
Learning objectives:
- Brief history and benefits of FHIR and the importance of interoperability in the healthcare sector
- Learn how various regulatory bodies are currently working and leveraging FHIR to improve processes with: EU EMA medicinal product information, US FDA Drug Labeling, Health Canada product monograph labeling
- Explore the prospective timelines and next steps for FHIR implementations and what it means for the future of healthcare
Presenters:
Mike Baird
Director of Product Management at Schlafender Hase
Mike is committed to continuously improving the existing software portfolio and at the same time also delivering new and innovative solutions to exceed customer needs. He has more than 25 years of experience working with global packaging, labeling, pre-media and artwork management leaders in the pharmaceutical and medical device sectors. Ensuring that the related risks of manual proofreading and approval processes are identified and solved quickly and easily, allowing only approved content to be printed or published.
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Gary Saner
Sr. Regulatory Principal in the Reed Tech Life Sciences group
Gary is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.
