For over 25 years, Peter Muller has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device & Consumer Goods. He has a wealth of experience working with international clients to define their organization’s goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.
The Essential Artwork Approval Checklist for Regulatory Affairs Professionals
Artwork approval is a crucial step for regulatory affairs (RA) professionals in labeling and packaging. Even minor oversights can lead to non-compliance, costly product recalls, and submission and product launch delays. To help navigate this complex process, we’ve compiled an essential artwork approval checklist that will streamline approvals, ensure compliance, and protect brand integrity.
Increased Focus on Promotional Compliance – Insights from OPDP and PAAB
In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.
Med Tech in a Globalized World: Overcoming Regulatory Compliance Challenges for International Success
Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.
How are increased compliance requirements impacting medical devices?
How are increased compliance requirements impacting medical devices? Discover the Future of Medical Device Regulation.We will dive into the rapid growth of the medical device sector, driven by cutting-edge technologies and rising regulatory requirements.
Rising regulatory demands: are medical device suppliers ready?
The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.
Soaring Medical Device Scrutiny: How is the Market Adapting?
In the light of new research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 device manufacturers in Europe and the US are adapting to a rise in regulatory controls. Published in MedTech Intelligence The global medical devices market is expected to grow from $542.21 billion in 2024 to $886.80 billion by 2032[1]. As devices become more critical to patient outcomes, regulators around the world are increasing their controls around their manufacturing, distribution, and monitoring – bringing suppliers of these products more closely into line with requirements around pharmaceutical goods. New research[2] has assessed how well manufacturers and their regional or national partners are adapting to the rising regulatory demands. The 2024 study, with 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), highlights the number of challenges currently vying for attention and investment and assesses device companies’ current state of regulatory readiness. Medical devices: the rise of regulatory requirements The study started by surveying medical device suppliers’ involvement with a number of regulatory initiatives. E-labeling/eIFU Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives, and up to a third of these (30%) are ‘very’ involved. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%). 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 (FHIR) is a proposed global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will make many regulatory professionals’ lives easier by shifting the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, helping to drive process digitization in the production and management of regulated medical device information and content. In the survey, three in five respondents (60%) claimed to be 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) makes it possible to track individual devices across the healthcare supply chain internationally. In the survey, two-thirds (66%) of respondents (rising to 74% of EU survey participants, but accounting for a much lower proportion in the US at 57%) express involvement in UDI activity. Anti-counterfeiting Taking proactive measures to mitigate the threat to product quality and patient safety posed by counterfeit products is a further expectation and robust product identification and traceability are a cornerstone of this practice, along with vigilant supply chain monitoring. In the survey, over half (55%) of respondents indicate at least some involvement with anti-counterfeiting. Navigating regulatory demands Medical device companies are dealing with the impact of increasing regulations in a number of ways, including the implementation of key standards (e.g. ISO);
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
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: 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
Tank Worldwide Case Study – Fast, focused quality control in advertising
The creative content from Tank WW includes text copy, videos, websites or micro-sites, email promotional material, PowerPoint presentations, and more. A proofreading team provides the quality control for advertising material to ensure accuracy, consistency and compliance across content and different media.
How FMCG and CPG Companies Can Improve Regulatory Risk Management for Packaging
In the rapidly changing and highly competitive Fast-Moving Consumer Goods (FMCG) sector, labeling and packaging plays an important role in brand identity, over and above its purpose of protecting the physical product.
How FMCG and CPG Companies Can Improve Regulatory Risk Management for Packaging
In the rapidly changing and highly competitive Fast-Moving Consumer Goods (FMCG) sector, labeling and packaging plays an important role in brand identity, over and above its purpose of protecting the physical product.
RAPS Webinar: e-Labeling and what it means for Regulatory Teams
E-labeling is no longer a future concept. Regulatory agencies worldwide, including the EMA, FDA, and MHRA, are advancing digital product information initiatives. But what does this mean for your daily work as a regulatory professional? How will your submission and labeling processes change? And how can you prepare today to avoid last-minute compliance risks?
RAPS Webinar: e-Labeling and what it means for Regulatory Teams
E-labeling is no longer a future concept. Regulatory agencies worldwide, including the EMA, FDA, and MHRA, are advancing digital product information initiatives. But what does this mean for your daily work as a regulatory professional? How will your submission and labeling processes change? And how can you prepare today to avoid last-minute compliance risks?
Schlafender Hase Brings Pharma-Level content review and compliance to the CPG Industry with a new cloud-native version of TVT
TVT, Schlafender Hase’s flagship software, has long been the trusted standard for document and label review in the pharmaceutical industry. The new cloud-native version builds on the same proven comparison engine at the core of the desktop product. With a responsive web interface, scalable microservices architecture, and standards-based RESTful APIs, it delivers enhanced flexibility, intuitive usability, and seamless integration with existing document and artwork management systems, making world-class quality control more accessible to CPG teams.
Schlafender Hase Brings Pharma-Level content review and compliance to the CPG Industry with a new cloud-native version of TVT
TVT, Schlafender Hase’s flagship software, has long been the trusted standard for document and label review in the pharmaceutical industry. The new cloud-native version builds on the same proven comparison engine at the core of the desktop product. With a responsive web interface, scalable microservices architecture, and standards-based RESTful APIs, it delivers enhanced flexibility, intuitive usability, and seamless integration with existing document and artwork management systems, making world-class quality control more accessible to CPG teams.
