Clinical Trials
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EMA meets industry stakeholders on scientific advice and clinical trial coordination
On 3rd July 2025 EMA conducted its annual meeting with representatives of industry stakeholders to address topics of evidence generation along the medicine’s life cycle and related product-development support activities, such as scientific advice…
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Serious clinical development players should avoid ‘hype’ and ‘hope’
Hype and hope are markers of bias and should be excluded from the scientific method. This approach has been obvious since the 19th century, when the most ‘revolutionary’ early researchers have been skeptical about their…
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The public consultation on Europe’s Paediatric Regulation
The Paediatric Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products) was adopted in 2007 to address a serious gap in knowledge on…
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ICH Readies new guidance
The Assembly finalised its rules of procedure, which reflect the new emphasis on clearer governance, transparency and openness in the operation of the reformed ICH, and will be published shortly. Key advances for public health…
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EMA and US FDA outline first assessment of quality-by-design applications
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements…