Mike is the Director of Product Management for Schlafender Hase. He is committed to continuously improving the existing software portfolio and at the same time also delivering new and innovative solutions to exceed customer needs. He has more than 25 years of experience working with global packaging, labelling, pre-media and artwork management leaders in the pharmaceutical and medical device sectors.
Top Regulatory Challenges in Food Labeling and How to Overcome Them
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
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.
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).
Introducing TVT 12: A New Era in Compliance and Efficiency
With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.
The Game-Changing Features of TVT 12: A New Era in Compliance and Efficiency
TVT 12 is here!
This annual update is packed exclusively with new features and improvements from customer requests that support key industry initiatives, boost efficiency, and add even more speed and detail to your document reviews.
The medical device sector’s surging regulatory burden: how are suppliers coping?
Regulators around the world are increasing their scrutiny of medical devices as these become more critical to patient outcomes. Referencing new research, Peter Muller and Mike Baird of Schlafender Hase consider how well Class 2 and 3 device manufacturers are adapting. Published in LifeSci Voice The global medical device industry is expected to be worth $886.80 billion by 2032[1]. It is no coincidence that company representatives now make up a growing proportion of attendees at Regulatory Affairs Professionals Society meetings. As devices become more critical to patient outcomes, regulators around the world are steadily increasing their associated safety controls. A new international benchmark report[2] considers how well manufacturers and their international partners are adapting to the rising regulatory demands. The 2024 study was conducted with 202 regulatory professionals at Class 2 and 3 device companies in the EU (Germany) and North America (the US). Emerging & intensifying regulatory requirements The research first tested medical device companies’ awareness of and current involvement with a number of increasingly prominent regulatory initiatives. E-labeling/eIFU E-labeling is high on the medical device regulation agenda on both sides of the Atlantic. Electronic information provision and management promotes standardization and consistency (e.g. of format and terminology), making it easier to manage and process the contents in any market. It also plays a key role in product traceability, a critical safety lever. Providing critical product information digitally (e.g. under expectations associated with electronic instructions for use, or eIFU) makes it easier to issue prompt updates, too. It also simplifies international content and translation management and, in the case of user advice or safety information, facilitates spontaneous online or mobile lookup by clinicians or patients. Crucially, e-labeling allows device manufacturers to provide more detail than can fit on a physical label. Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%, respectively). This makes sense as the EU is ahead of the US with the practice; companies here are also less likely to outsource labeling as a service. FHIR/standardized data exchange Fast Healthcare Interoperability Resources is a proposed new global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will shift the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, promoting the digitization of the production and management of regulated medical device information and content. In the survey, three in five respondents (60%) were involved with the standard, rising to 67% for EU (German) respondents; in the US, only just over half were occupied with FHIR (FHIR is not as high profile in the US), though the FDA is encouraging manufacturers to adopt interoperability standards. UDI/device identification Unique device identification (UDI) employs a unique numeric or alphanumeric code to identify individual devices across the healthcare supply chain. Although approached slightly differently, a UDI system is advocated by both EMA and the FDA. Benefits include expedited and more targeted
Learning the New Language of the EMA & The FDA: FHIR
Watch our interactive discussion session focusing on the evolution and outlook of Fast Healthcare Interoperability Resources (FHIR).FHIR represents a significant step in how we manage and exchange information and is rapidly gaining acceptance. In this session, industry experts will provide an introduction to the FHIR initiative, explore some current applications as well as the impacts, benefits and prospective timelines.
The Rise of Regulatory Requirements for Medical Devices
Peter Muller & Mike Baird of Schlafender Hase how well they think suppliers are adapting to new regulatory demands for Class 2 and 3 Medical Device Manufacturers.
Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.
Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.
Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Top Regulatory Challenges in Food Labeling and How to Overcome Them
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
Top Regulatory Challenges in Food Labeling and How to Overcome Them
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
