The field of medical product safety continues to grow in complexity, with both clinical trial safety and postmarketing pharmacovigilance becoming ever more critical in the development and ongoing evaluation of safe use of marketed medical products. The inherent limitations of premarketing testing and constant focus on the risks associated with medical product use have fostered new thinking and methods for monitoring the evolving safety profiles of marketed products throughout their life cycle. Further, while the field of risk management has added a new dimension to product safety, as a maturing discipline it requires ongoing refinement in order to enhance its applicability and value to public health.

This comprehensive four-day program will address the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use via discussion of the latest safety-related regulatory initiatives, descriptions of how to optimally utilize epidemiological, clinical pharmacological and other techniques, presentation of illustrative examples of risk management strategies, and debate as to how all of this can be pulled together into an effective organizational “System”.

Among the special areas that will be covered are:

·        The latest international regulatory developments, including

-         US FDA and EMEA risk management initiatives

-         The global impact of EU pharmacovigilance inspections by various regulatory authorities

-         Updates on implementation of Volume 9A and other European safety-related regulatory requirements

-         Japanese regulatory agency organizational changes

-         Pharmacovigilance programs in Asia/Pacific Rim and China

-         Update on pharmacovigilance in Central America and South America

·        Generating and assessing critical safety data during development

-         Role of animal toxicology studies

-         Application of clinical pharmacology in establishing product safety profile

-         Statistical considerations in analyzing premarketing data

-         Benefit-risk Assessment

-         The Integrated Summary of Safety

·        Compliance with clinical safety and postmarketing pharmacovigilance regulatory requirements in an evolving global environment

·        Relationship between compliance and quality in safety-related processes and procedures

·        Recent multinational initiatives under the International Conference on Harmonization (ICH) and Council for International Organizations of Medical Sciences (CIOMS) on Drug Safety Update Reports (DSURs) in premarketing clinical trial safety

·        New approaches in risk management, risk communication, labeling and packaging to optimize medical product benefit while minimizing preventable harm

·        Patient safety – a shared responsibility

TUTORIALS, JANUARY 11, 2009

·        Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art

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