EOM 1352: Fri 7 June 2024, 11:36
Catalyst 7 July 2023, 14:52

Current Edition

Discovery Park: Wed 13 November 2024, 10:35
ramusmedical
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FDA Regulatory Perspectives on Barth Syndrome and Rare Diseases

Barth syndrome (BTHS) is a paediatric-onset, ultra-rare disease characterised by cardiac abnormalities that can result in various health challenges, including an enl...
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Developing Robust Submission Strategies for Combined Studies

Medical interventions increasingly involve the use of technology and devices. New treatments may involve a medical device, combination product or in vitro diagnostic...
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The Strategic Imperative of Quality Management in Pharmaceuticals and Biotechnology

In the highly regulated pharmaceutical and biotechnology industries, quality management serves as the bedrock for ensuring product safety, efficacy, and regulatory c...
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Good Review Process – The New Panacea

Over the last 25 years, the way we write regulatory documents has evolved – from lean writing to technology that aids in populating the reports we write, things have...
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Next-generation AI Process Automation Essential to Cope with Soaring Regulatory Workloads, Survey Finds

A new survey of senior US regulatory professionals has confirmed a direct correlation between unsustainable regulatory workloads and planned AI investment. That’s as...
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Study Designs and Digital Technologies for Sustainable Clinical Trials

The clinical trial industry is essential for ensuring the safety and efficacy of new medicines; however, it is also a significant contributor of greenhouse gas emiss...
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The Role of Company Culture in Functional Service Provider (FSP) Partnerships

Pharmaceutical and clinical research sponsors (clients) have long outsourced clinical development work, utilising both full-service contract research organisations (...
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Targeting the End of Malaria by 2050

Malaria continues to have a significant impact on half of the world’s population who live in tropical regions. It claims 600,000 lives each year, the majority of who...
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An Interview with Dr. John Stone, Steritas

There is increasing, and necessary, attention on an open secret: the epidemic of steroid-toxicity. We sat down with Dr. John Stone, Professor of Medicine at Harvard ...
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Digital Health Technologies are Inherently Remote – Lets not Burden Sites with Them

There is ongoing and increasing interest in using digital health technologies (DHTs) in clinical trials for clinical endpoints. By changing the yardstick by which ou...
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Catalyst: Fri 8 November 2024, 14:16
Pharmap: Wed 13 November 2024, 10:36
Biosynth: Wed 13 November 2024, 10:18