Regulatory Strategy Forum for Pharmaceuticals

9:00 am

Welcome and Day I Overview

9:10 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, senior director, regulatory affairs, The Medicines Company

9:45 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

11:00 am

Obtaining Buy In for Regulatory Strategy

This session will evaluate the process of 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.

11:30 am

Case Study Analysis and Group Work: Part 1

Participants will be divided into teams that will each begin prepare a global regulatory strategy (GRS) for the fictitious product. This session will introduce you to your fictional product, the Regulatory Strategy Document (RSD) template and the expectations for the template’s completion. The faculty will provide considerations for teams to examine in working to complete Part 1 of the strategy template and review the information that should be documented in these sections using a case study from an actual product strategy.

1:30 pm

Group Presentations: Part 1

In this session, the groups will present their results from the completion of Part 1 of the RSD with an active Q&A session.

All Faculty

2:00 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 how to address common key international hurdles. 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

2:40 pm

Applying Regulatory Intelligence 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

3:30 pm

Case Study Analysis, RSD Expectations and Instructions: Part 2

This session will review the portions of the RSD and the information that should be documented in each section, using a case study from an actual product strategy. 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

4:00 pm

Group Work: Part 2

Teams will work to complete the sections in Part 2 of the RSD template for your fictitious product.

All Faculty

8:30 am

Day II Overview

8:40 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, senior director, regulatory affairs, The Medicines Company

10:30 am

Case Study Analysis RSD Expectations and Instructions: Part 3

This session will review the portions of the RSD and the information that should be documented in each section, using a case study from an actual product strategy. 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

11:00 am

Group Work: Part 3

Teams will work to complete the sections in Part 3 of the RSD template for your fictitious product.

All Faculty

1:00 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

2:00 pm

Hot Topics From Around the World

This session will discuss regulatory trends in the US, Europe and ROW.

All Faculty

3:00 pm

Hot Topics From Around the World (continued)

4:00 pm

Wrap-up and Final Q & A Session