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3 Lessons Learned from Pandemic-Era Clinical Development Regulatory Practices

HIT Consultant

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. The pandemic has given rise to new norms in drug development that will influence the future of the industry as we know it. The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools.

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Overcoming Key Hurdles in Decentralized Trials with Better Education

HIT Consultant

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Further underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID. Improving Protocol Compliance.

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Future Trends and Regulatory Challenges in Pharma

Dot Compliance

The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace. The next evolution is for companies to implement Industry 4.0 What will the near future bring to the table? References.

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Health Provider News – February 18, 2022

Hall Render

CMS may now enforce its COVID-19 vaccination policy for healthcare workers in all 50 states. HHS seeks $30B to combat COVID-19. Meet new FDA chief Dr. Robert Califf: 5 things to know. Only 14% of Hospitals Met Price Transparency Rule Compliance. Outpatient push being felt in architecture industry.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

COVID-19 Response: Freely Available ISO Standards, 18 June 2021. A number of ISO standards have been made available to support global efforts to address the COVID-19 crisis. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.

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