Tutorial #1: Risk Management Planning: Strategies and Tools for Development and Implementation
Wednesday, November 5, 1:30 - 5:00 PM

INSTRUCTOR

• Yola Moride, PhD, FISPE, President, ISPE; Associate Professor, Faculty of Pharmacy, University of Montreal, Canada

Risk management planning is integrated throughout a product’s life cycle as potential safety concerns are identified at each stage of the development and previously identified concerns are continuously re-assessed as new evidence is generated. Risk management planning has been formally integrated in the regulatory process in the USA and the EU. Based on the safety specification, strategies for the detection and evaluation of unknown or potential risks must be designed, and specific risk minimization activities may be required. Risk management planning is multi-dimensional as it involves multiple risks, heterogeneous populations, and varying levels of evidence. The plan must therefore present, for each risk issue, a structured and logical strategy using tools that will enhance the value of the peri- and post-approval drug safety program.

The purpose of this tutorial is to present the scope of risk management planning and summarize the US three draft guidances as well as the EU requirement and template. Some of the strategies that may be considered will be presented: what is included in the tool box? what can epidemiology do for preparing some of the safety specification? and what kind of studies might be done in the post-marketing setting? Some of the concepts will be presented through risk management plans that have been published.

WHO SHOULD ATTEND

• Drug safety and pharmacovigilance directors
• Clinical research scientists
• Outcomes research specialists

Tutorial #2: Innovative/Adaptive Designs for Clinical Trials: Applicability - Risks - Benefits
Wednesday, November, 5, 1:30 - 5:00PM

INSTRUCTORS

• Miklos Schulz, PhD, President and CEO, SciAn Services, Inc., Canada
• St. Clare Chung-Hun, MA, MSc, Director of Biostatistics and Data Management, SciAn Services, Inc., Canada

Adaptive designs (modifying design assumptions of ongoing clinical trials based on accumulating data) introduces flexibility within the trial to reduce risk and increase the probability of success of clinical research programs. When used properly, adaptive designs will minimize patient exposure to non-promising treatments while increasing the efficiency of the trial from a time and financial perspective.

The purpose of this tutorial is to provide a non-technical overview of existing adaptive designs including methods for dose-finding (maximum tolerated dose). We will also go beyond the usual statistical issues and discuss the planning, logistical and regulatory issues that must be covered when an adaptive design is being considered.

WHO SHOULD ATTEND

• Medical directors
• Clinical research professionals