Join Industry Experts and Regulators to Improve Your Safety Analysis During Drug Development, Analyze and Mitigate Potential Risks, and Explore New Solutions and Approaches to Developing Safe and Effective Medications, including those to treat Type 2 Diabetes Mellitus.
Participate in debate-style presentations and hear commentary and presentations from international industry, academic, and regulatory speakers to help you optimize your cardiovascular safety assessment and improve the development of medications to treat Type 2 Diabetes Mellitus and other diseases.
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• This meeting will offer plenary sessions and two tracks – one for Diabetes topics and one for CV safety topics
• Interact with FDA and other regulatory agency participants
• Scientific abstract presentation sessions
• Robust networking opportunites
At the conclusion of this conference, participants should be able to:
• Summarize the evidence for cardiovascular risk with new and existing T2DM drugs.
• Recognize the current and evolving regulatory initiatives for CV Safety of T2DM drugs.
• Discuss how new regulations will impact clinical development of new T2DM drugs.
• Evaluate scientific data from preclinical and clinical sources, pre- and post-marketing strategies, and other innovative approaches to drive future efforts to develop efficient approaches to the development of T2DM drugs.
• Identify approaches to assure CV safety is appropriately defined in the development of T2DM drugs.
• Recognize the state-of–the-art approach to performing the thorough QT study, including novel trial designs and understand the potential uses of PK/PD Modeling.
• Explain the different approaches to assessing QT in Phase 3 when a QT signal has been identified in Phase 2.
• Describe how to evaluate drugs for CV risk
• Define the Benefit:Risk considerations confronting regulators and payors/providers.
• Identify major issues in assessing BP changes during drug development.
• Recognize the potential safety issues associated with drug-induced BP changes.
• Explain the major issues in clinical CV safety evaluation.
• Describe new approaches to evaluating post-marketing safety assessment.
• Pharmaceutical executives
• Academic scientists
• Pharmaceutical cardiac safety experts
• Clinical diabetology experts
• Clinical epidemiology experts
• Regulatory affairs specialists
• Biostatisticians and data managers
• Project teams working in Endocrine/Metabolic areas
• Preclinical safety experts
• Biomarker professionals
• ECG lab and equipment vendors
• Regulatory specialists
12009 Co-sponsored with FDA and Heart Rhythm Society