The shift toward electronic labeling (e-labeling) and electronic Product Information (ePI) is no longer a distant future, it's happening now. For Regulatory Affairs teams, this transformation brings both questions and opportunities. If you’re wondering what this shift means for your daily work, you're not alone.
Quality management is a crucial element in any operations. However, it is especially important for regulatory affairs professionals in regulated industries such as pharmaceuticals and medical devices, as well as in fast-moving consumer goods sectors (FMCGs) like food and cosmetics. Quality assurance provides the basis for market approval, helping prevent quality lapses that could trigger compliance actions or endanger public safety.
As regulatory bodies move toward structured electronic product information (ePI) in FHIR XML format, life sciences organizations are under pressure to evolve. That includes how you verify and proofread content.
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.
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.
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.
Across the Crop Science sector, both user and environmental safety are of highest priority. In this buyer’s guide, we will go over seven steps that will help you in your purchasing process, to ensure that you end up with the proofreading software you need.
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.
As the world shifts towards electronically delivered e-Labeling, it's essential to stay ahead of the game. Regulatory Authorities are now permitting and encouraging online e-PIL content, with other regions follow suit.
