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.
It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator’s neck. Can you afford the costs of a recall or product delay?
Earth Day is a commitment to safeguarding and enhancing our natural environment, with an anticipated mobilization of over 1 billion people in 2024. At Schlafender Hase, when we thought about how Earth Day affected us as individuals and a company, we unanimously agreed: it’s especially about trees and minimizing use of paper.
The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.
The costs of medical device recalls can run well into the millions of dollars. In terms of numbers of devices recalled, heading the unfortunate list of medical device recalls in recent times is a Class I recall of 38 million Vial2Bag fluid transfer systems by West Pharmaceuticals in 2019.
Proofreading regulated documents in pharma presents unique challenges. Avoid the high risk of costly mistakes with best practices and by leveraging technology.
