Much like in the pharmaceutical and medical device sectors, where the adoption of such software has proven to reduce workloads and the risk of errors that may cause recalls or stop-sales, the Crop Science industry is also beginning to recognize the value of integrating this technology.
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.
The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can “talk” to each other. The term we use for how compatibly systems work together is “interoperability.” Traditionally, the healthcare sector has suffered from a high lack of interoperability.
Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.
In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.
In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.
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.
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.
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
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.
