MORNING PRE-CONFERENCE WORKSHOP
9:00 AM – 11:45 AM

Hosted by
Pragmatic Approaches to FDAAA: A Decision Tree Approach to Successful REMS Creation and Risk Assessment Studies

This interactive workshop will present you with facts and challenges about a safety issue from early identification of the signal to design and implementation of a Risk Evaluation and Mitigation Strategy (REMS). Included will be discussion of how to lead an organization in REMS decisions (Decision Tree Approach), creation, documentation, evaluation and implementation activities. You will also take part in discussions of key considerations for Risk Assessment studies. Experts will guide you through a defined process and timeline including key decision points in risk management plans, creation of documentation and materials for Regulatory filing, implementation of a minimization program, and evaluation of the REMS. Key Lessons Learned:

• Establishing a process pathway to gain multifunctional cooperation
• Identifying key decision points for risk management during product development
• Deciding which risks require long-term assessment (but not immediate mitigation) -- Conducting postmarketing observational studies for Risk Assessment
• Deciding which risks are worthy of mitigation -- Designing and evaluating risk management “tools”; Establishing an infrastructure for risk minimization; Understanding results of a risk management program evaluation; Reporting effectiveness of risk management programs to regulatory agencies

Your Workshop Leaders:
Abbe Steel, Executive Director, Trial Enhancement Services, United BioSource Corporation
Bob Sharrar, M.D., MSc, BA, Executive Director, Epidemiology and Risk Management, United BioSource Corporation
Kelly D. Davis, M.D., Vice President, Epidemiology & Risk Management, United BioSource Corporation

Your workshop leaders are experts in safety signaling, risk assessment and risk minimization, having been involved in 25 regulatory mandated studies for risk assessment; signal detection and evaluation for more than 40 products and over 30 risk management programs.

9:00 Part I
10:00 Networking Refreshment Break
10:30 Part II

AFTERNOON PRE-CONFERENCE WORKSHOP
1:15 PM – 4:15 PM

Hosted by
Practical Approaches to Lifecycle Signal Detection

This interactive workshop will present practical approaches to signal management during pre and post market development phases. For today’s stakeholders in drug safety, data integration between pre and post market phases along with signal detection automation have never been more important. Workshop leaders will present objectives for pharmacovigilance, specifically focusing on factors that can influence signal detection. Experts will examine signal detection tools and techniques that address real life drug safety issues. Proactive procedures for Signal definition, detection, evaluation and documentation will be explored as the attendees are exposed to methods for issue resolution and risk communication. Key Lessons Learned:

• Identify practical approaches for signal management during lifecycle product development
• Appreciate and apply qualitative and quantitative signal management methods
• Understand factors that may influence signal identification
• Understanding the collaboration necessary between good clinical evaluation and data mining
• Appreciate the value of establishing a “Proactive Safety Culture” and the steps necessary to optimize signal management procedures

Your Workshop Leaders:
Elizabeth Garrard, Pharm.D, R.Ph, Chief Safety Officer, Drug Safety Alliance, Inc.
Aliceson Y. King, M.D., MPH, Medical Director, Drug Safety Alliance, Inc.
Susan L. McCready, Lincoln – Principal Consultant, Phase Forward

Elizabeth E. Garrard, PharmD., R.Ph. serves at Drug Safety Alliance, Inc.’s (DSA) Chief Safety Officer and has been with DSA since its beginning. Her current responsibilities include leadership in strategic planning, analysis, development, implementation and measurement of all aspects of drug safety, pharmacovigilance and risk management for DSA. Dr. Garrard has over 30 years of clinical and regulatory experience spanning the pharmaceutical, clinical, pharmacovigilance, hospital and retail industries.

1:15 Part I
2:30 Networking Refreshment Break
3:00 Part II