16-JJ risk management adrian thomas version 2.pptVIP

Risk ManagementA Manufacturers Perspective Dr Adrian Thomas MBBS FRACP MRACMA Global Head Benefit Risk Management Chief Safety Officer Risk Management is not new!!! Risk Management All therapeutic interventions have some risk The key principle is to maximize the benefit-risk profile by: Treating patients who will benefit Excluding patients at risk Risk Management is important for rational use Risk Management Starts with knowledge of pre-clinical data Ends when product no longer in human use Many regulatory guidances describe requirements and principles Risk Management is not easy Risk Management:Basic Building Blocks Risk Identification Risk Characterization Risk Quantification Risk Mitigation Risk Communication Risk Monitoring Risk Management Data Sources Preclinical Clinical Postmarketing Manufacturing / Quality Product Class/Comparator Risk Management Clinical trials have limitations Good at defining benefits in controlled populations Good at detecting common risks, or predictable (pharmacological) risks Poor for defining idiosyncratic, rare or unpredictable risks Population studied not real world patient Our evaluation of benefits and risks needs to continue throughout the product lifecycle in real world populations and be part of a risk management plan Difficulty In Excluding Rare Risks-Upper 95% C.I. for observed rate of 10 per 100,000 PY Basic Requirements Good quality standardized data Enough trained people Tools validated methodology for data analysis Processes allowing action in timely way Ability to communicate risk and impact behaviour Risk Management at Johnson Johnson Pharmaceutical Companies Benefit Risk Management (BRM) BRM is the central pharmacovigilance organization supporting companies in the Pharma Consumer groups of JJ Includes drugs, biologics, devices, OTC, cosmetics Pharmacovigilance data and risk assessments are core outputs supporting the value proposition of our products Safety Efficacy Outcomes BRM Orga