PharmaTech
DECEMBER 2, 2023
The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.
PharmaTech
DECEMBER 2, 2023
Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
PharmaTech
DECEMBER 2, 2023
Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
PharmaTech
DECEMBER 2, 2023
By taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.
PharmaTech
DECEMBER 2, 2023
Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
PharmaTech
DECEMBER 2, 2023
Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
PharmaTech
DECEMBER 2, 2023
The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
PharmaTech
DECEMBER 2, 2023
The bio/pharmaceutical industry is struggling with the challenge of staffing and training.
PharmaTech
DECEMBER 2, 2023
Collaboration is a key component to achieving long-term success with genetic medicines.
PharmaTech
DECEMBER 2, 2023
Digital transformation allows for smarter and connected biomanufacturing operations.
Advertisement
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
PharmaTech
DECEMBER 2, 2023
FDA and industry face unprecedented political and policy challenges.
PharmaTech
DECEMBER 2, 2023
Matching excipients to API properties is essential.
PharmaTech
DECEMBER 2, 2023
What does the 2024 VPAS mean for pharma?
Expert insights. Personalized for you.
52 
Let's personalize your content