Global Information Inc. is pleased to announce a new Conference, "Mitigating Safety Risks in Early Clinical Development" by Cambridge Healthtech Institute.
This 2-day conference will address the pressing issues that drug safety experts currently face. The scheduled programs focus on clinical risk assessment and bridging the gap between preclinical data and clinical studies and offer strategies to better assess, predict and mitigate safety risks. The aim of this event is for everyone, regardless of their specific role, to learn from those working earlier or later in drug development and furthermore, for the industry to better bridge the gap between preclinical, clinical and post-approval drug safety.
- Corporate Risk Management: Shared Session with Post-Approval Drug Safety Strategies
- Data mining
- Comparative benefit risk assessment
- Improving Early Safety Assessment
- Achieving the promise of translational research: overcoming scientific and organization challenges to improve early risk assessment
- Idiosyncratic DILI: How good are currently available biomarkers and which new biomarkers should we look for?
- Challenges in preclinical safety testing to predict human cardiovascular toxicity in phase 2/3 clinical trials and post-marketing
- Better Linking Preclinical Data, Clinical Studies and Post-Approval Drug Safety (Shared Session with Post-Approval Drug Safety Strategies)
- Bridging the gap between preclinical data, clinical studies, and post-approval drug safety.
- Better integrating clinical and preclinical safety to achieve translational safety.
- Lessons unlearned: determining risks from clinical trials
- Translational toxicology as part of risk management throughout the life cycle of a product.
- New Technologies and Methods
- Looking to the future of prediction: the promise and reality of new technologies
- Quantitative intravital multiphoton microscopy of the liver
- Cardiac functional assessment: a comparison of invasive vs. non-invasive techniques with a view to improved translational applicability
- Novel methods to assess cardiovascular risk
- Predicting serious adverse events using mechanism of action
- Drug-induced mitochondrial dysfunction yields a novel model of idiosyncratic toxicity
- Idiosyncratic liver injury: challenges and approaches
- Novel 3-dimensional ECG/VCG cardiac safety markers in the early clinical development
- Use of informatics approaches for establishing a threshold of toxicological concern