FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018 and has been revised with industry comments. Section 303(f)(3) of the Federal Food, Drug, and […]
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices, and solutions. One of the six stated goals of the study was specifically to “Quantify […]
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to believe that a quality system is not in a state of control. During inspection, we […]
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate, communicate and take action on potential PV risks, as needed. You have identified a signal…Now […]
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may […]
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of excellent information not previously available in any published form. It covers notification, planning, conduct, documentation, system […]
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs and regulatory operations. A diverse set of independent or loosely […]
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will submit a single submission in electronic format. Because a medical device premarket submission in electronic […]
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and integrate regulatory correspondence. But for large companies planning product divestitures, RIM provides a vital function. […]
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”. The sessions featured 24 speakers representing the FDA, EMA, large pharma, CROs/AROs, clinical vendors, […]
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with respect to quality in the products that we deliver. Pharmacovigilance software is synonymous with reliability […]
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Chet Shemanski is a proven business and information technology professional with extensive experience serving the healthcare and global life sciences industries. He has specific expertise in software product commercialization including product management, product marketing, solution strategy, and alliance management. Chet is a subject matter expert in eClinical and eRegulatory technologies, the author of industry journal articles and a speaker at industry conferences.