EMA Invites Comments on Good Biomarker Practice
The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices.
The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices.
The outcome of the consultation will inform a guideline, which will set criteria to underpin the generation of robust clinical genomic datasets throughout a medicine’s lifecycle, the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the appropriate level of analysis and reporting of genomic data. The goal is to enhance transparency, consistency, reproducibility and cross-validation between genomic-driven studies.
Comments on the paper are invited until October 31, 2014 and should be sent to pgwpsecretariat@ema.europa.eu.
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
