| 7:30 am |
Registration and Continental Breakfast |
| 8:30 am |
Welcome and Day I Overview |
| 8:40 am |
Regulatory Strategies: Where should you start?
This session will examine the basics of regulatory strategy formation including why strategy is important, what is involved in developing a strategy, and the importance of assessing the regulatory landscape, the intended claims and speed to market when determining your regulatory strategy.
Mark Kramer, RAC, president, Regulatory Strategies Inc. |
| 9:15 am |
Business Considerations: Regulatory’s Role and Partnerships
This session will evaluate the role of the regulatory professional as a strategic partner in business as well as how the strategy should be impacted by various business arrangements and environment changes, such as, in-licensing, mergers, international expansion and line extension strategy, the competitive landscape or co-development projects.
Patrick Johnson, senior director, regulatory affairs, Medtronic Neuromodulation |
| 10:00 am |
Case Study Analysis and Group Work: Part 1
This session will introduce you to your fictional medical device, the global regulatory strategy template and the expectations for its completion. Participants will be divided into teams that will each prepare a GRS for the fictitious medical device. The faculty will provide considerations for the teams to examine in working to complete Part 1 of the strategy template.
All Faculty |
| 10:30 am |
Refreshment Break |
| 11:00 am |
Case Study Analysis and Group Work: Part 1 (continued) |
| 12:00 pm |
Group Presentations: Part 1
In this session, groups will present their results from completion of Part 1 of the GRS with an active Q&A session.
All Faculty |
| 12:30 pm |
Lunch |
| 1:30 pm |
Developing Regulatory Strategies for a Global Market
The session will focus on incorporating global requirements into your regulatory strategy. You will learn how to drive the project team to think globally and you will address key international hurdles often encountered. This session will also highlight some of the unique registration requirements in the major and emerging markets outside the US.
Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation |
| 2:15 pm |
Role of Regulatory Intelligence in Strategy Development
This session will illustrate the role of regulatory intelligence in developing a global regulatory strategy document, and the various sources of information available to stay current on the global regulatory environment.
Mark Kramer, RAC, president, Regulatory Strategies Inc. |
| 2:45 pm |
Case Study Analysis and Group Work: Part 2
This session will review the portions of the RSD and the information that should be documented in each of these sections. Participants will continue to work in their teams to prepare the GRS for the fictitious medical device. The faculty will provide considerations for the teams to examine in working to complete Part 2 of the strategy template.
All Faculty |
| 3:15pm |
Refreshment Break |
| 3:45 pm |
Case Study Analysis and Group Work: Part 2 (continued) |
| 4:15 pm |
Obtaining Buy-in for Regulatory Strategy
This session will evaluate the process involved in presenting your regulatory strategy to organizational decision makers in order to obtain buy-in and approvals. Project planning needs for successful execution of your strategy will also be highlighted.
Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation |
| 5:00 pm |
Adjourn |
| |
| 8:00 am |
Registration and Continental Breakfast |
| 8:30 am |
Day II Overview |
| 8:45 am |
Group Presentations: Part 2
In this session, groups will present their results from completion of Part 2 of the GRS with an active Q&A session. |
| 9:15 am |
Regulatory Strategies: A Living Document
This session will outline how to keep your regulatory strategy current as it progresses through development and how to deal with marketplace or regulatory changes.
Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation |
| 9:45 am |
Refreshment Break |
| 10:15 am |
Case Study Analysis and Group Work: Part 3
This session will review the sections of the RSD and the information that should be documented in each of them. Participants will continue to work in their teams to prepare the GRS for the fictitious medical device. The faculty will provide considerations for the teams to examine in working to complete Part 3 of the strategy template.
All Faculty |
| 11:15 am |
Group Presentations: Part 3
In this session, groups will present their results from completion of Part 3 of the GRS with an active Q&A session. |
| 12:30 pm |
Lunch |
| 1:30 pm |
Hot Topics From Around the World
This session will discuss regulatory trends in the US, Europe, and ROW, with a special focus on product continuation, post approval, and strategies for product changes.
All Faculty |
| 2:45 pm |
Wrap Up |
| 3:00 pm |
Adjourn |