Sponsored Webcast: Learning the New Language of the EMA & The FDA: FHIR (On Demand)
Join us for an interactive discussion session focusing on the evolution and outlook of Fast Healthcare Interoperability Resources (FHIR).
FHIR represents a significant step in how we manage and exchange information and is rapidly gaining acceptance. In this session, industry experts will provide an introduction to the FHIR initiative, explore some current applications as well as the impacts, benefits and prospective timelines.
Registration Fees & Deadlines
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
Who Should Attend?
Any Regulatory Professionals working in the creation of products: - Clinical Trial – Data - Labeling
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speakers
Peter Muller
Director Sales Americas, Schlafender Hase
For over 25 years, Peter Muller has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device & Consumer Goods. He has a wealth of experience working with international clients to define their organization's goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.
Mike Baird
Director of Product Management, 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.
Gary Saner
Senior Regulatory Principal, LexisNexis Reed Tech
Gary Saner 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.
