Katarina Kresankova

Ensuring Patient Safety: Medical Device Recall Process and Prevention Strategies

The costs of medical device recalls can run well into the millions of dollars. In terms of numbers of devices recalled, heading the unfortunate list of medical device recalls in recent times is a Class I recall of 38 million Vial2Bag fluid transfer systems by West Pharmaceuticals in 2019.

Read More!

How to Reduce Drug Labeling Errors in Pharma

FDA (US), EMA (EU), ANSM (France), CFDA (China), BfArM (Germany) – just to name a few of the national and international bodies that regulate the pharmaceutical industry. They share a common purpose: to ensure the patient safety and efficacy of medicines. And for this, they have regulatory procedures.

Read More!

How to Attract and Retain Regulatory Affairs Professionals

As we move through 2022, Human Resource (HR) departments and recruiters are looking at the impact of the Great Resignation on regulatory affairs. The current trend to job switching, the “Great Resignation”, may be flattening out in some professions in mid-2022, but the difficulty of attracting and retaining top talent in regulatory affairs remains an ongoing challenge for pharmaceutical companies, and the stakes are high.

Read More!

Pharmathen – TVT Increases Employee Satisfaction and Doubles Productivity

At Pharmathen, this tedious part of the proofreading process was identified as the bottleneck, so Management was mandated to find a tool that would assist their team. By alleviating the need for manual proofreading, Pharmathen was hoping to increase employee satisfaction, and consequently increase production.

Read More!

January 13, 2025

Schlafender Hase Team

E-labeling: The Road to Efficient Pharmaceutical Labeling and Packaging

Practical next steps for pharmaceutical manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

< 1 minute read

E-labeling: The Road to Efficient Pharmaceutical Labeling and Packaging

Practical next steps for pharmaceutical manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

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.

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.

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).

4 minutes read