Audio Conference

Risk Management for Opioid Products Dr. Edgar Adams Executive Director, Epidemiology Late Stage Development Services Covance Purchase CD &CD-ROM - US $145

Purchase a CD of this audio conference 

In March 2005, the FDA released the final guidance on Pre-Market Risk Assessment, Risk Minimization Action Plans (RiskMAP), and Pharmacovigilance. The intent of these plans is to maximize the benefit of the medication while minimizing the risk, thereby ensuring that the benefit/risk ratio remains positive. Many of the tools available through a well designed RiskMAP are used for opioids analgesics. However, these tools are applicable to the population for whom the drug is intended (patients) rather than the population for whom the drug is not intended (extra-medical users/addicts). This presentation will discuss the use of these tools (e.g. labeling, targeted education and outreach) as well as the additional burden imposed by use in the population for whom the medication is not intended.

This audio conference will address:

• Goals of a RiskMap for the intended (patient) population
• FDA concerns and additional burdens imposed on opioid analgesics
• Increasing requirements for post-marketing surveillance
• Goals of a RiskMAP for the unintended (abuser/addict) population
• Risk Management Strategies for the patient population
• Characteristics of surveillance strategies for the abuser/addict populations
• Review of current strategies
  

About the speaker:

Dr. Adams is Executive Director, Epidemiology with the Late Stage Development Services unit at Covance, and is responsible for providing scientific and technical leadership in epidemiology, clinical outcomes, and risk management.

Dr. Adams spent 23 years as a Commissioned Officer in the U.S. Public Health Service. At the time of his departure, he was Director of the Division of Epidemiology and Prevention Research at the National Institute on Drug Abuse, responsible for the Nation's Drug Abuse Surveillance effort. He went on to serve as Senior Vice President for Clinical Research and Risk Management at Harris Interactive, and subsequently began a consulting practice focusing on the design, assessment and implementation of risk minimization action plans, post-marketing surveillance, drug scheduling nationally and internationally, and drug abuse epidemiology.

Dr. Adams has a BS in Pharmacy from Fordham University, an MS in Pharmacology from Purdue and a doctorate in Health Policy and Management from Johns Hopkins School of Public Health.

Who should attend?

• Benefit/Risk Managers
• Drug Safety Managers
• Regulatory Affairs
• Marketing
• Senior Management
  

This audio conference is classified as General Interest.

Registration Options

• Purchase CD & presentation CD-ROM US$145