STANLEY B. GARBUS, MD, MPH

PRESIDENT, CHIEF MEDICAL OFFICER

GLOBAL SAFETY SURVEILLANCE, INC.

ABSTRACT

Regulatory and public scrutiny of pharmacovigilance practices has increased corporate risks and liability. Integrated safety surveillance systems and proactive crisis management plans are necessary to minimize these risks. This presentation will present a realistic view of the who, what, and where of today’s clinical safety monitoring and reporting that is critical to satisfy regulatory and public health interests. The lecture will focus on the various factors influencing the practice of pharmacovigilance, the major issues facing companies and regulatory agencies, and how these issues need to be addressed to succeed in the global marketplace.

Companies must be able to proactively identify potential signals from background noise, and act upon them before public safety is affected and corporate liability is incurred. At the core of prudent management of product safety is a proactive crisis management plan. The essence of advanced planning integrates comprehensive pharmacovigilance with unified response capabilities for communication with corporate staff, regulators, healthcare professionals, attorneys and, most importantly, the public.

Specific topics to be addressed in this presentation will include:

• Establishing worldwide safety surveillance systems to satisfy international regulatory requirements and internal reporting needs
• The application of epidemiological strategies to drug safety assessments and postmarketing safety surveillance, including signal generation and trend analysis
• Performance metrics for pharmacovigilance
• Recent FDA regulatory changes and the impact on pharmaceutical companies
• Managing product safety: strategies to minimize risk
• Managing global safety harmonization
• Assessing the probability of product relationship: turning information into knowledge
• What makes a situation a potential crisis
• Crisis management: planning and action
• Current challenges for an industry-best safety surveillance system