13–14 November 2008
Orlando, FL
Walt Disney World Dolphin

Program Description

An effective global regulatory strategy maximizes commercial opportunities while minimizing risk. Strategies should incorporate regional needs while considering the larger global “big picture”. Although a “one-size-fits-all” approach is highly desirable, the dynamic global regulatory environment precludes such a tactic often causing companies to view the preparation of a global strategy as too challenging or, alternatively, underestimate the effort required.

This program will provide the tools regulatory professionals need to better understand what is involved in creating a successful global regulatory strategy and how to monitor and revise that strategy based on the continually changing regulatory landscape. You will examine vital subjects such as the standards necessary for developing your strategy, the essential elements of a Global Regulatory Strategy Document (GRSD), Target Product Profile (TPP), Design Dossier, Common Technical Document (CTD) and Risk Management tools. You will also participate in developing a global strategy using case studies of approved drugs and devices.

Learning Objectives

• Define the role of regulatory strategy in product development and lifecycle management
• Discuss the tools necessary for developing a global regulatory strategy
• Outline the major components of a Global Regulatory Strategy Document (GRSD)
• Identify ways to mitigate regulatory risk through management of the strategy plan

Who Should Attend

Mid-level regulatory professionals from industry and consulting firms who have understand the basics of and have experience with IND, NDA, BLA and PMA submissions.

Levels: II, III

Key Topics

• Regulatory strategies in the context of corporate planning and initiatives
• Global Considerations for devising your strategy
• Applying tools and standards to strategy development
• Creating a Global Regulatory Strategy Document (GRSD)
• How GRSD supports regulatory submissions planning
• Executing your regulatory strategy

Program Chair

Sarah Powell, RAC, executive director, regulatory strategies, Thomson Reuters Sarah Powell is the executive director of regulatory strategies for Liquent, a Thomson Reuters company. She has more than 20 years of experience in the pharmaceutical and related regulated industries. For the last seven years, Powell has worked on a variety of projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading software solutions. While in industry, Powell performed a variety of roles within the clinical, quality, regulatory affairs and regulatory operations groups. She has extensive experience with FDA’s guidance for electronic submissions, including recently established requirements for electronic submission of labeling information (SPL and PIM).

Program Faculty

Brad Hossack, international vice president, international regulatory affairs, Boston Scientific Corporation
Brad Hossack is the international vice president of regulatory affairs for Boston Scientific Corporation. He has been in regulatory for more than 20 years, spending the past 11 years at Boston Scientific. His focus has been on international marketplaces with responsibility for all international regulatory activities outside the US. Hossack’s responsibilities have included business and regulatory issues associated with registration/compliance in the complex regulatory environments of Japan, Asia, Latin America, Canada, Australia and Europe, such as regulatory staffing, lobbying, registration and compliance at the regional and country levels. Hossack began his regulatory career with Baxter Healthcare Corporation in Canada, where he was responsible for the regulation of hazardous goods and the registration and compliance of medical devices, diagnostics, pharmaceutical and biologics products. He later moved to Baxter’s international division, focusing on medical devices, parenteral solutions and biologics for the Latin American, Asian and Middle Eastern markets. Hossack holds a BSc (Hons) from the University of Guelph, Canada.

Tamima Itani, PhD, RAC, vice president, global regulatory affairs, medical devices, Baxter Healthcare Corporation
Tamima Itani is the vice president, global regulatory affairs, medical devices, Baxter Healthcare Corporation. Previously, she was vice president, clinical and regulatory affairs for ev3 Inc. and vice president, quality systems and regulatory affairs for Ethicon Endo-Surgery Inc. Her responsibilities have included strategic regulatory, clinical and quality systems leadership for a broad range of Class II and Class III medical devices, pharmaceutical products and combination products. Itani holds a BS in electrical engineering from the American University of Beirut and MS and PhD degrees in biomedical engineering from Northwestern University.

Alan V. McEmber, MS, RAC, director, worldwide regulatory strategy, Pfizer
Alan McEmber is the director of worldwide regulatory strategy at Pfizer. He has more than 20 years regulatory product development experience in drugs, biologics, devices and combination products. Prior to joining Pfizer, McEmber was with 3M Pharmaceuticals, Parke-Davis, Boehringer Ingelheim and Alexion Pharmaceuticals. He has been responsible for providing regulatory liaison agency support and strategy throughout the product lifecycle, beginning in discovery and product development, through clinical investigation and market authorization. McEmber has also been involved with the development, submission and management of documentation in support of INDs, IDEs, NDAs and PMAs. He has experience in the pulmonary, anti-inflammatory, cardio-renal, metabolism/endocrine, ophthalmic and urology therapeutic areas. McEmber holds a BS in microbiology from the University of Michigan and an MS from the University of Minnesota. He is a lecturer at Columbia University, teaches a course on biopharmaceutical development and regulatory and is Regulatory Affairs Certified (RAC).