Resources

May 26, 2023

Schlafender Hase Team

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.

3 minutes read

How to Reduce Drug Labeling Errors in Pharma

May 23, 2023

Schlafender Hase Team

Regulatory Guidelines for Labeling in Pharma

Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

4 minutes read

Regulatory Guidelines for Labeling in Pharma

May 8, 2023

Schlafender Hase Team

Regulatory Affairs – Partnering for Knowledge

As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.

2 minutes read

Regulatory Affairs – Partnering for Knowledge

May 5, 2023

Schlafender Hase Team

RAPS Sponsored Webcast: The Foundations of AI: A Non-Technical Introduction for Regulatory Affairs Professionals

AI is already being used in many Life Science applications, meanwhile, Health Authorities are looking to regulate the use of AI. As a regulatory affairs professional, it is essential to have an understanding of this technology.In this general introduction to the field of AI, different uses of the term "Artificial Intelligence" will be discussed, and which might be desirable in a given context.

2 minutes read

RAPS Sponsored Webcast: The Foundations of AI: A Non-Technical Introduction for Regulatory Affairs Professionals

May 4, 2023

Schlafender Hase Team

Introducing e-Labelling For Medical Devices

In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address. This will take them to the latest details, in an easily digestible format - often including audio and video options now, for maximum accessibility.

5 minutes read

Introducing e-Labelling For Medical Devices

May 3, 2023

Schlafender Hase Team

Why is labeling important in the pharmaceutical industry?

Bringing a new drug to market demands a large investment on the part of a pharmaceutical company – often, $ 1 billion or more. Ensuring compliance with complex labeling regulations is part of that investment. In the following we look at why pharmaceutical labeling is so important and the different types of labeling.

4 minutes read

Why is labeling important in the pharmaceutical industry?

April 19, 2023

Schlafender Hase Team

Preparing for a Paperless Future: How the Medical Device Sector is Embracing e-labelling

As the medical device sector continues to rapidly evolve, it is becoming increasingly important to ensure that patients and healthcare professionals have access to up-to-date product and safety information. E-labelling provides a convenient way to share important information. Here, Schlafender Hase’s Peter Muller explores the advantages of e-labelling for the medical device sector, as well as providing some practical tips for getting ahead with the processes, procedures and solutions necessary for a successful transition to e-labelling.

5 minutes read

Preparing for a Paperless Future: How the Medical Device Sector is Embracing e-labelling

April 18, 2023

Schlafender Hase Team

Reducing Medical Device Packaging Waste and Improving Information Provision Through E-Labelling

E-labelling offers patients and healthcare professionals the convenience of always having up-to-date information on their products, such as the latest safety updates. It also provides regulators with greater oversight and assurance that manufacturers are providing accurate and timely information. Dr. Jutta M. Hohenhörst, from Schlafender Hase, explores the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies and add value for patients.

3 minutes read

Reducing Medical Device Packaging Waste and Improving Information Provision Through E-Labelling

April 12, 2023

Schlafender Hase Team

E-labeling: The Road to Reduced Medical Device Packaging Material

New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.

5 minutes read