This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.
Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. The cadence of publication steadily increased as ICH Q8, ICH Q10, and ICH Q11 emerged, as thought leaders sought to provide practical guidance to industry on the application of QRM. This article will focus on selected publications addressing general, rather than specific, applications of QRM.
The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases to increase the likelihood of success during inspection for licensure of a facility. This article discusses the final two phases.
Pharmaceuticals, large and midsize, have a long history of rewarding reactive firefighting as opposed to proactively identifying problems and preventing issues from occurring. As a result, proactive risk management and the cultural change that goes with it have been a hard sell.
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.
Learn what U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity guidance.
At the BIO-Europe Spring Conference in Amsterdam in March 2018, CRA hosted a special program where attendees from biotech, Big Pharma, healthcare provider/payer groups, and patient associations were asked to share their views on pricing strategies for innovative medicine, including cell and gene therapies. More than 60 attendees responded to a series of questions about drug pricing, with a focus on cell and gene therapies, and their responses were captured live through an instantaneous voting system during a panel session.
The industry will see a mixture of new emerging trends and an evolution of historical trends heavily influenced by technology innovation and AI. The next year promises to be an exciting one that will strengthen the position of some existing leaders and elevate some new companies focused on building forward-looking platforms that will deliver future innovation and growth.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is effectively and clearly documenting procedures and work instructions that are easy to understand and execute. This article presents the requirements for documenting QMS procedures and work instructions, and then introduces methods to effectively and clearly do so.
This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.