4:30 Roundtable Discussions:
Concurrent round tables are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a roundtable of interest to them and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
Table 1. Evaluation of Risk Minimization Interventions
 Yola Moride, Ph.D., FISPE, Associate Professor of Pharmacy, Université de Montréal; President, International Society for Pharmacoepidemiology (ISPE)
This is the last section of the EU risk management template, and often is problematic for the industry. What are the methods of evaluation and what are people in drug safety risk management doing?
Table 2. Outsourcing Post Approval-Drug Safety
 Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth
Table 3. Managing DMC Processes for Maximal Independence
 Catherine A. Tyner, M.A., M.F.A., A.B.D., Global Director, CEVA, Safety Services, Drug Safety & Medical Affairs, Quintiles, Inc.
Jill Edwards, Associate Director, CEVA, Drug Safety & Medical Affairs, Quintiles, Inc.
Table 4. Choice of Databases for Safety Surveillance
 Michael D. Blum, M.D., M.P.H., Vice President, Global Safety Surveillance and Epidemiology, Wyeth Research
With increasing availability of spontaneous report, claims, and large-linked databases that can conceivably be used for prospective safety surveillance, the choice of databases by industry is by no means simple and has significant resource implications.
Table 5. Marketing and Drug Safety: Enemies or Allies
 Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet
Table 6. Costs and Opportunities of Phase IV Risk Management Programs
 Nayan T. Nanavati, Vice President and General Manager, Peri and Post Approval Research (PACE), Americas, PAREXEL International
Utility of Post Marketing Clinical Trials, specifically registries, in Risk Identification and Risk Management is a well established concept. However, we can expend and optimize the role of post marketing studies to better manage safety risks associated with a marketed product. We will evaluate current practices, evolving roles and cost implications of late phase studies in Risk Management programs
Table 7. Expanded Access Programs
 Joanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme
With the prospect of approval of an effective new agent come demands to make it available quickly. There are a variety of ways that can be done, each with its advantages and limitations. This is an opportunity to share experiences and consider options that are available
Table 8. Drug Interaction Programs
Facilitator to be Announced
Table 9. Identifying and Managing Pharmacovigilance Risk with Alliance Partners
 Ashraf Youssef, M.D., Ph.D., M.B.A., Associate Medical Director, Pharmcovigilance, Takeda Pharmaceuticals
- Models of safety management among partners/alliances
- Examples of challenging issues in safety management among partners/alliance
- Best practices in managing safety issues among partners/alliances
Table 10. Organizational Structure (Operations) in Pharmaceutical Companies for Drug Safety and Risk Management
Cathy Sigler, Ph.D., M.P.H., Senior Director, Epidemiology Risk Management, United BioSource Corporation
Gwyneth Moya, M.P.H., Epidemiology Risk Management, United BioSource Corporation
Table 11. The Use of Post Marketing Surveillance Data (e.g., spontaneous reports) to Fulfill Risk Management Obligations
 Robert Bader, Pharm.D., Director of Drug Safety Services, Covance Periapproval Services
This discussion will include the pros and cons of utilizing post marketing data to address safety questions posed by regulatory authorities. Considerations for global safety departments will be highlighted, as well as data quality and cost efficiencies.
|