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Safety and pharmacovigilance and risk management professionals must utilize best practices in current daily operations while anticipating coming changes associated with new therapies and technologies.
Expand your knowledge of all new regulations, regulatory pathways, data sources, technologies, and cutting edge therapeutic products, and discover how to adapt your pharmacovigilance and risk management strategies to remain effective while keeping pace with change.
The Pharmacovigilance and Risk Management Strategies eBook provides information you need to help ensure your pharmacovigilance programs are built on a foundation supported by strong strategic planning and practical decision-making.
Don't miss out on DIA's best-in-class Pharmacovigilance and Risk Management Strategies Conference, January 22-24, in Washington, DC!
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Highlights |
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FDA Updates – including pharmacovigilance and risk management for CBER-regulated products, as well as experiences in safety and surveillance of generic drugs
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The New ICH – including an overview of recent changes to the ICH; the New ICH E19 Guideline on Optimization of Safety Data Collection – industry and regulatory perspectives
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EU Regulatory Updates – including GVP Module 5 (RMPs) revision, EudraVigilance access policy revisions, new EudraVigilance requirements, and the impact of Brexit
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Combination Products – use-related errors and device failures, Safety Reporting Rule, and technical specifications for safety reporting of combination products
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Clinical Trial Issues – including importance of patient perspectives on toleration in development of the safety profile of investigational products; global harmonization of pragmatic safety requirements in clinical trials; the EU Clinical Trials Regulation
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