FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
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 […]
Ennov will once again be exhibiting at the SCOPE Summit for Clinical Ops Executives. This year marks the 10th annual SCOPE conference and Ennov’s 2nd year participating. The SCOPE Summit 2019 takes place 18-21 February at the Hyatt Regency Orlando […]
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand the clinical risk in light of multiple impacting factors, in a demonstrably controlled manner. Benefit/risk […]
Ennov will be exhibiting at the Society of Clinical Data Management (SCDM) Annual Conference, being held in Seattle-Bellevue, Washington (USA), from 23-26 September 2018. The SCDM Annual Conference is the world’s largest Clinical Data Management Conference, offering unrivalled opportunities to […]
The 2018 Ennov User Group Meeting was recently held in New Orleans, Louisiana. Over 100 Ennov users from 10 different countries participated in the three-day meeting along with 15 Ennov employees. There were three different tracks offered this year, which […]
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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.