Regulatory Insights
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China’s Recent Drug Scandals: What Do They Mean For Foreign Drug Makers?
2/20/2019
Recent scandals surrounding Chinese drug manufacturers have Chinese nationals looking outward, and have even sparked regulatory reforms. This lost faith in local drug companies begs the question: what does this mean for foreign investors?
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Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle
6/19/2019
The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. This Webcast provides an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. Hot topics such as Brexit, combination products, E2B(R3), EVDAS/eRMR, medical device regulations, and IDMP are also included.
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Virtual Clinical Trials Best Practices
10/16/2019
In recent years, alongside the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.
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Safety, Pharmacovigilance, And Risk Management Plans In China
1/27/2020
China joining the International Council for Harmonization (ICH) in 2017, and China’s subsequent announcement to follow relevant ICH guidelines such as E2, M1 and M4 in 2018, is continuing to change the conduct of pharmacovigilance in China. Read more about the aspects of these regulatory changes and resulting industry needs.
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Why And How Global Healthcare Product Regulators Are Joining Forces
3/13/2020
The ICMRA is now considered a strategic cross-border leader among a select group of global medicine and device regulatory policy bodies. Read how the coalition is working across the world to help sponsors develop medical products in a more globally harmonized way moving forward.
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Revised Common Rule Compliance Now In Full Effect—And What That Means
2/18/2020
How does the revised Common Rule affect your research? On January 20, 2020, we reached the final compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”). Get the facts here!
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FDA Inspections Need Not Be Stressful
6/30/2020
As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.
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EudraVigilance Survival Guide
5/14/2019
What it is, why it is important, and what sponsors need to think about as it gets closer.
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Using Egnyte For Life Sciences As GxP Repository
1/6/2021
Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.
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Tips For Submitting Expedited Review Studies
4/1/2020
Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.