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Discussion with Rote Liste

March 11, 2025

Schlafender Hase Team

The Future of Patient Information: A Discussion on GI 4.0® with Manuela Wiegand from Rote Liste

The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®)—Germany’s move toward digital patient information leaflets.

Discussion with Rote Liste
  • March 11, 2025
  • By: Philipp Thomas
4 minutes read

The Future of Patient Information: A Discussion on GI 4.0® with Manuela Wiegand from Rote Liste

The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®)—Germany’s move toward digital patient information leaflets.

Promotional Compliance

March 10, 2025

Schlafender Hase Team

Increased Focus on Promotional Compliance – Insights from OPDP and PAAB

In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.

Promotional Compliance
  • March 10, 2025
  • By: Peter Muller
5 minutes read

Increased Focus on Promotional Compliance – Insights from OPDP and PAAB

In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.

Ensure Compliance in Cosmetic Labeling

March 7, 2025

Schlafender Hase Team

Ensure Compliance with the Latest Cosmetic Trends and Regulations

As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.

Ensure Compliance in Cosmetic Labeling
  • March 7, 2025
  • By: Marc Chaillou
5 minutes read

Ensure Compliance with the Latest Cosmetic Trends and Regulations

As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.

Health Canada XML Updates

March 4, 2025

Schlafender Hase Team

Health Canada’s XML Product Monograph Update: What It Means for Regulatory Teams

Health Canada has announced changes to the filing requirements for Extensible Markup Language (XML) Product Monographs (PMs), signaling a shift toward enhanced digital documentation standards. The first phase of these requirements come into effect on July 18, 2025. These updates will impact regulatory teams, requiring adjustments in their processes to meet the new expectations.

Health Canada XML Updates
  • March 4, 2025
  • By: Vineed Ravindranath
3 minutes read

Health Canada’s XML Product Monograph Update: What It Means for Regulatory Teams

Health Canada has announced changes to the filing requirements for Extensible Markup Language (XML) Product Monographs (PMs), signaling a shift toward enhanced digital documentation standards. The first phase of these requirements come into effect on July 18, 2025. These updates will impact regulatory teams, requiring adjustments in their processes to meet the new expectations.

February 5, 2025

Schlafender Hase Team

Med Tech in a Globalized World: Overcoming Regulatory Compliance Challenges for International Success

Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.

  • February 5, 2025
  • By: Peter Muller
6 minutes read

Med Tech in a Globalized World: Overcoming Regulatory Compliance Challenges for International Success

Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.

The Future of Labels: Embracing Digital Technology for Enhanced Efficiency

February 3, 2025

Schlafender Hase Team

The Future of Labels: Embracing Digital Technology for Enhanced Efficiency

Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.

The Future of Labels: Embracing Digital Technology for Enhanced Efficiency
  • February 3, 2025
  • By: Mike Baird
5 minutes read

The Future of Labels: Embracing Digital Technology for Enhanced Efficiency

Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.

8 Trends Shaping the Future of Drug Labeling

January 12, 2025

Schlafender Hase Team

8 Trends Shaping the Future of Drug Labeling

Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.

8 Trends Shaping the Future of Drug Labeling
  • January 12, 2025
  • By: Katarina Kresankova
4 minutes read

8 Trends Shaping the Future of Drug Labeling

Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.

Learning the New Language of the EMA and FDA: FHIR

January 7, 2025

Schlafender Hase Team

RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR

As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).

Learning the New Language of the EMA and FDA: FHIR
  • January 7, 2025
  • By: Mike Baird
4 minutes read

RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR

As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).

TVT e-Learning

December 5, 2024

Schlafender Hase Team

Elevate Your Expertise with TVT e-Learning: Training for Precision and Professional Growth

When you work in a regulated industry where the risk of mistake is high, staying proficient with your tech stack and compliant with evolving standards is essential. With TVT being a cornerstone for many professionals in document review and labeling accuracy, Schlafender Hase has introduced a comprehensive e-Learning portal.

TVT e-Learning
  • December 5, 2024
  • By: Schlafender Hase
2 minutes read

Elevate Your Expertise with TVT e-Learning: Training for Precision and Professional Growth

When you work in a regulated industry where the risk of mistake is high, staying proficient with your tech stack and compliant with evolving standards is essential. With TVT being a cornerstone for many professionals in document review and labeling accuracy, Schlafender Hase has introduced a comprehensive e-Learning portal.

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TVT e-Learning Portal

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