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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 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.

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.

Off Label Marketing

May 17, 2024

Schlafender Hase Team

Off Label Marketing: How to Avoid False Claims in Pharma

The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case

Off Label Marketing
4 minutes read

Off Label Marketing: How to Avoid False Claims in Pharma

The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case

EU MDR medical device regulations

May 8, 2024

Schlafender Hase Team

Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations.

EU MDR medical device regulations
4 minutes read

Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations.

Exploring the extensive costs associated with product recalls

April 24, 2024

Schlafender Hase Team

The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator's neck. Can you afford the costs of a recall or product delay?

Exploring the extensive costs associated with product recalls
4 minutes read

The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator's neck. Can you afford the costs of a recall or product delay?

Paperless Document Reviews

April 8, 2024

Schlafender Hase Team

Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

Earth Day is a commitment to safeguarding and enhancing our natural environment, with an anticipated mobilization of over 1 billion people in 2024. At Schlafender Hase, when we thought about how Earth Day affected us as individuals and a company, we unanimously agreed: it's especially about trees and minimizing use of paper.

Paperless Document Reviews
4 minutes read

Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

Earth Day is a commitment to safeguarding and enhancing our natural environment, with an anticipated mobilization of over 1 billion people in 2024. At Schlafender Hase, when we thought about how Earth Day affected us as individuals and a company, we unanimously agreed: it's especially about trees and minimizing use of paper.

Best practices for your promotional review process

March 22, 2024

Schlafender Hase Team

Best Practices for your Promotional Review Process

The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.

Best practices for your promotional review process
4 minutes read

Best Practices for your Promotional Review Process

The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.