| TUESDAY, 17 AUGUST |
| 7:00 am |
Registration and Continental Breakfast |
| 8:00 am |
Welcome and Day I Overview |
| 8:10 am |
Regulatory Strategies: Where Should You Start?
This session will examine the basics of regulatory strategy formation, including what is involved in creating a strategy, why strategy is important and the importance of the intended claims for determining your regulatory strategy. The development of a pharmaceutical product will be explored.
Katharine Reinisch, DVM, director worldwide regulatory strategy & quality assurance, Pfizer Inc. |
| 8:45 am |
Business Considerations: Regulatory’s Role and Partnerships
This session will evaluate the role of the regulatory professional as a strategic partner to business, as well as how the strategy may be impacted by various business arrangements, such as in-licensing, mergers or co-development projects.
Alan McEmber, RAC, senior director, immunology, global pharma regulatory affairs, Abbott |
| 9:30 am |
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.
Sarah Powell, RAC, executive director, regulatory strategies, Liquent |
| 10:00 am |
Refreshment Break |
| 10:15 am |
Case Study Analysis: Part 1
This session will review portions of the Regulatory Strategy Document (RSD) and the information that should be documented in these sections using a case study from an actual product strategy.
All Faculty |
| 10:45 am |
Group Work Introduction
This session will introduce you to your fictional product, the global regulatory strategy template and the expectations for its completion. Participants will be divided into teams that will each prepare a global regulatory strategy (GRS) for the fictitious product.
All Faculty |
| 11:00 am |
RSD Expectations, Instructions and Group Work: Part 1
The faculty will review the projected outcomes for these sections of the RSD template and provide some considerations for the teams to examine in working to complete Part 1 of the RSD for your fictitious product.
All Faculty |
| 12:00 pm |
Lunch |
| 1:00 pm |
Group Presentations: Part 1
In this session, a selected group will present their results from completion of Part 1 of the RSD with an active Q&A session.
All Faculty |
| 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 both major and emerging markets.
Alan McEmber, RAC, senior director, immunology, global pharma regulatory affairs, Abbott |
| 2:10 pm |
Applying Tools and Standards to Strategy Development
This session will illustrate some of the tools available to help develop a global RSD and will explore current regulatory standards and expected implementation timelines.
Sarah Powell, RAC, executive director, regulatory strategies, Liquent |
| 2:30 pm |
Case Study Analysis: Part 2
This session will review the portions of the RSD and the information that should be documented in each of these sections using a case study from an actual product strategy.
All Faculty |
| 3:00 pm |
Refreshment Break |
| 3:30 pm |
RSD Expectations, Instructions and Group Work: Part 2
The faculty will review the projected outcomes for these sections of the RSD template and provide some considerations for the teams to examine in working to complete Part 2 of the RSD template for your fictitious product.
All Faculty |
| 5:00 pm |
Adjourn |
| |
| WEDNESDAY, 18 AUGUST |
| 7:30 am |
Registration and Continental Breakfast |
| 8:30 am |
Day II Overview |
| 8:45 am |
Group Presentations: Part 2
In this session, a selected group will present their results from completion of Part 2 of the RSD with an active Q&A session.
All Faculty |
| 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 market or regulatory condition changes.
Katharine Reinisch, DVM, director worldwide regulatory strategy & quality assurance, Pfizer Inc. |
| 10:00 am |
Refreshment Break |
| 10:30 am |
Case Study Analysis: Part 3
This session will review the portions of the RSD and the information that should be documented in each these sections using a case study from an actual product strategy.
All Faculty |
| 11:15am |
RSD Expectations, Instructions and Group Work: Part 3
The faculty will review the projected outcomes for these sections of the RSD and provide some considerations for the teams to examine in working to complete Part 3 of the RSD for your fictitious product.
All Faculty |
| 12:00 pm |
Lunch |
| 1:00 pm |
RSD Expectations & Instructions: Part 3 (continued) |
| 2:00 pm |
Group Presentations: Part 3
In this session, a selected group will present their results from completion of Part 3 of the RSD with an active Q&A session.
All Faculty |
| 2:30 pm |
Wrap Up |
| 3:00 pm |
Adjourn |