| 8:30–10:00 am |
Opening Plenary: The Tipping Point
Stefan Larsson, MD, PhD, senior partner, managing director, Boston Consulting Group |
| 10:00–10:20 am |
Break |
| 10:20 –11:20 am |
Opening Plenary Continues
Daniel Diermeier, PhD, IBM Professor of Regulation and Competitive Practice, Kellogg School of Management, Northwestern University |
| 11:20 am–12:00 pm |
Expert Panel Discussion
Stefan Larsson, MD, PhD, senior partner, managing director, Boston Consulting Group
Daniel Diermeier, PhD, IBM Professor of Regulation and Competitive Practice, Kellogg School of Management, Northwestern University |
| 12:00–1:00 pm |
Lunch |
| 1:00–2:30 pm |
The Tipping Point: Sector-specific Considerations (concurrent)
Medical Device Plenary:
Michael Gropp, vice president, global regulatory strategy, Medtronic
Jan Pietzsch, PhD, president and CEO, Wing Tech Inc
Larry Kessler, ScD, Professor and Chair, Department of Health Services, School of Public Health, University of Washington
Biopharmaceutical Plenary:
Christopher-Paul Milne, DVM, MPH, JD, associate director, Tufts Center for the Study of Drug Development
|
| 2:30–2:45 pm |
Break |
| 2:45–3:45 pm |
Sector-specific Considerations: Expert Panel Discussions (concurrent)
Medical Device Panelists:
Michael Gropp, vice president, global regulatory strategy, Medtronic
Sabina L. Hoekstra-van den Bosch, MSc, PharmD, senior advisor, Ministry of Health, Welfare and Sports, Netherlands
Larry Kessler, ScD, Professor and Chair, Department of Health Services, School of Public Health, University of Washington
Jan Pietzsch, PhD, president and CEO, Wing Tech Inc
Biopharmaceutical Panelists:
Christopher-Paul Milne, DVM, MPH, JD, associate director, Tufts Center for the Study of Drug Development
Robert Peterson, MD, PhD, MPH, executive director, Drug Safety and Effectiveness Network (DSEN)
Hans-Georg Eichler, MD, MSc, senior medical office, European Medicines Agency (EMA)
Michael Ringel, JD, PhD, partner and managing director, Boston Consulting Group
|
| 3:45–4:00 pm |
Break |
| 4:00–5:30 pm |
Breakout Discussions: “You are Here” (Sector Specific) |
| 5:30–6:30 pm |
RAPS Networking Wine Reception |
|
|
| 8:45–10:00 am |
Plenary Session: Day One Recap/Setting the stage for Day Two
Moderators from breakout sessions |
| 10:00–10:15 am |
Break |
| 10:15–11:45 am |
Plenary Session: New Business Drivers–The Call for Regulatory Leadership
Paul LaViolette, MBA, venture partner, SV Life Sciences
Robert Peterson, MD, PhD, MPH, executive director, Drug Safety and Effectiveness Network (DSEN) |
| 11:45 am–12:45 pm |
Lunch |
| 12:45–2:00 pm |
Regulatory’s Role: Sector-specific Expert Panel Discussions (concurrent)
Medical Device Panelists:
Michael Gropp, vice president, global regulatory strategy, Medtronic
Sabina L. Hoekstra-van den Bosch, MSc, PharmD, senior advisor, Ministry of Health, Welfare and Sports, Netherlands
Grant Ramaley, director of regulatory affairs, Aseptico Inc
Biopharmaceutical Panelists:
Christopher-Paul Milne, DVM, MPH, JD, associate director, Tufts Center for the Study of Drug Development
Robert Peterson, MD, PhD, MPH, executive director, Drug Safety and Effectiveness Network (DSEN)
Hans-Georg Eichler, MD, MSc, senior medical office, European Medicines Agency (EMA)
Michael Ringel, JD, PhD, partner and managing director, Boston Consulting Group |
| 2:00–3:30 pm |
Breakout Discussions: Regulatory’s Role in Creating and Driving Solutions |
| 3:30–4:00 pm |
Break |
| 4:00–5:00 pm |
Plenary Session: Day Two Summary and Closing Remarks |
| 5:00 pm |
Adjourn |