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Learning the New Language of the EMA & The FDA: FHIR

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Mike Baird
2 minutes read
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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

 

Watch the webinar on-demand: 

Boost your FHIR expertise in just 3 weeks—sign up for our exclusive email series today!

Presenters:

Mike Baird

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.

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.

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

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Mike Baird

Director of Product Management, Schlafender Hase

Mike is the Director of Product Management for Schlafender Hase.

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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

 

Watch the webinar on-demand: 

Boost your FHIR expertise in just 3 weeks—sign up for our exclusive email series today!

Presenters:

Mike Baird

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.

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.

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

Subscribe to our blog

Past Webinars

E-labeling and what it means for regulatory teams

May 29, 2025

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RAPS Webinar: e-Labeling and what it means for Regulatory Teams

E-labeling is no longer a future concept. Regulatory agencies worldwide, including the EMA, FDA, and MHRA, are advancing digital product information initiatives. But what does this mean for your daily work as a regulatory professional? How will your submission and labeling processes change? And how can you prepare today to avoid last-minute compliance risks?

E-labeling and what it means for regulatory teams
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E-labeling is no longer a future concept. Regulatory agencies worldwide, including the EMA, FDA, and MHRA, are advancing digital product information initiatives. But what does this mean for your daily work as a regulatory professional? How will your submission and labeling processes change? And how can you prepare today to avoid last-minute compliance risks?

TVT Integration Webinar

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TVT Integration: Connect, Automate, Accelerate

Learn how new custom integration capabilities make it easy to connect TVT with the systems you already use; enabling greater automation, reducing manual effort, and accelerating review processes, all while maintaining the precision and compliance standards you rely on.

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TVT Integration: Connect, Automate, Accelerate

Learn how new custom integration capabilities make it easy to connect TVT with the systems you already use; enabling greater automation, reducing manual effort, and accelerating review processes, all while maintaining the precision and compliance standards you rely on.

Esko Precision Talks Webinar

May 22, 2025

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Precision Talks: Optimizing Packaging Workflows with Compliance and Innovation

Join Chris Janczar from Esko and Marc Chaillou from Schlafender Hase for an exclusive discussion on how automation and digital maturity can transform your packaging workflows. This session is designed for professionals who are responsible for optimizing workflows, approving artworks, and reducing risk in their packaging process.

Esko Precision Talks Webinar
< 1 minute read

Precision Talks: Optimizing Packaging Workflows with Compliance and Innovation

Join Chris Janczar from Esko and Marc Chaillou from Schlafender Hase for an exclusive discussion on how automation and digital maturity can transform your packaging workflows. This session is designed for professionals who are responsible for optimizing workflows, approving artworks, and reducing risk in their packaging process.