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August 22, 2024

Schlafender Hase Team

FHIR: Transforming Product Labeling

The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

6 minutes read

FHIR: Transforming Product Labeling

The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

Empowering Pharma and Regulatory Frameworks with Structured Content

August 15, 2024

Schlafender Hase Team

Empowering Pharma and Regulatory Frameworks with Structured Content

Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

Empowering Pharma and Regulatory Frameworks with Structured Content
5 minutes read

Empowering Pharma and Regulatory Frameworks with Structured Content

Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

Structured Content in Product Labeling

August 9, 2024

Schlafender Hase Team

The Importance of Structured Content in Product Labeling

In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

Structured Content in Product Labeling
4 minutes read

The Importance of Structured Content in Product Labeling

In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

The_Role_of_Barcodes_in_Life_Sciences_and_How_to_Ensure_Accuracy

August 8, 2024

Schlafender Hase Team

The Role of Barcodes in Life Sciences, and the Key to Ensuring Barcode Accuracy

As the world shifts towards electronically delivered e-Labeling, it's essential to stay ahead of the game. Regulatory Authorities are now permitting and encouraging online e-PIL content, with other regions follow suit.

The_Role_of_Barcodes_in_Life_Sciences_and_How_to_Ensure_Accuracy
< 1 minute read

The Role of Barcodes in Life Sciences, and the Key to Ensuring Barcode Accuracy

As the world shifts towards electronically delivered e-Labeling, it's essential to stay ahead of the game. Regulatory Authorities are now permitting and encouraging online e-PIL content, with other regions follow suit.

The Critical Impact of Labeling Errors in the Pharmaceutical Industry

August 8, 2024

Schlafender Hase Team

The Critical Impact of Labeling Errors in the Pharmaceutical Industry

In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

The Critical Impact of Labeling Errors in the Pharmaceutical Industry
2 minutes read

The Critical Impact of Labeling Errors in the Pharmaceutical Industry

In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

Med Device Labeling Management Guide

August 8, 2024

Schlafender Hase Team

Best Practices for Medical Device Label Management Compliance

Managing medical device labels presents a myriad of challenges for manufacturers, including ensuring compliance with ever-evolving regulatory standards, maintaining accuracy and consistency in label content, and optimizing label design for clarity and usability.

Med Device Labeling Management Guide
2 minutes read

Best Practices for Medical Device Label Management Compliance

Managing medical device labels presents a myriad of challenges for manufacturers, including ensuring compliance with ever-evolving regulatory standards, maintaining accuracy and consistency in label content, and optimizing label design for clarity and usability.

August 8, 2024

Schlafender Hase Team

2024 Medical Device Compliance Strategies Research Report

As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing. But how well prepared are suppliers? We recently commissioned independent research to find out.

3 minutes read

2024 Medical Device Compliance Strategies Research Report

As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing. But how well prepared are suppliers? We recently commissioned independent research to find out.

Regulatory Tools: AI Revolutionizing Promo Review

June 11, 2024

Schlafender Hase Team

Regulatory Tools: Revolutionizing Promo Review

Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.

Regulatory Tools: AI Revolutionizing Promo Review
5 minutes read

Regulatory Tools: Revolutionizing Promo Review

Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.

How TVT helps the top 5 functions of regulatory professionals

June 5, 2024

Schlafender Hase Team

How TVT helps the Top 5 Functions of Regulatory Professionals

The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.

How TVT helps the top 5 functions of regulatory professionals
3 minutes read

How TVT helps the Top 5 Functions of Regulatory Professionals

The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.