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.
Labeling compliance is important. Find out why, and discover how you can ensure your product labeling is compliant with regulations for pharmaceutical and food products.
Navigating complex labeling requirements for medical devices. Your guide to the fundamentals of regulation and compliance and how automated proofreading can minimize your labeling risks.
With electronic labeling gaining momentum across healthcare markets, are you ready to maximize the benefits?
Digital transformation is all the rage these days, but what does that actually mean for professionals working with regulated content in Pharma and Med Device, and more importantly, what does it mean for you? Join us on November 10th as we explore the why and how of a digital proofreading workflow.
Join Schlafender Hase as we discuss the challenges faced by life science companies when it comes to ensuring the accuracy of all digital and printed material and how technology can play an integral role in improving this process.
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.
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.
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.
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.
