MONDAY, 15 SEPTEMBER
How Did I Get Here? Career Development Panel
Professional Levels: I, II
11:00 am - 12:00 pm | Room 310
This session will feature successful senior regulatory professionals who will present and discuss their career paths, providing a myriad of roadmaps from which the developing regulatory professional can learn. It will also allow professionals to hear from those who have gone before and succeeded and give new professionals an opportunity to learn from experienced regulatory leaders.
Session Leader:
Robert E. Yocher, RAC, vice president, regulatory affairs and corporate quality compliance, Genzyme Corporation
Speakers:
Kathleen S. Grim, RAC, executive director, regulatory compliance, Sepracor Inc.
David S. Mantus, PhD, vice president, regulatory affairs, Cubist Pharmaceuticals Inc.
Robert E. Yocher, RAC, vice president, regulatory affairs and corporate quality compliance, Genzyme Corporation
Internships/Mentoring: Best Practices for Developing New Regulatory Professionals
Professional Levels: II, III, IV
1:30 - 3:00 pm | Room 310
One of the greatest challenges facing the regulatory profession is how to identify, hire and keep qualified professionals.
This session presents you with best practices for developing young regulatory professionals, from a company standpoint. A panel discussion will emphasize mentoring programs, buddy systems, internships and specific company practices in the industry. You will learn what has worked in the past and what does not work when hiring, training and developing new members of the regulatory team.
Session Leader:
Martha J. Carter, RAC, senior vice president, regulatory affairs and quality assurance, Proteon Therapeutics
Speakers:
Martha J. Carter, RAC, senior vice president, regulatory affairs and quality assurance, Proteon Therapeutics
S. Albert Edwards, PharmD, RAC, director of operations, regulatory affairs, TAP Pharmaceutical Products Inc.
Donald A. Middlebrook, vice president, corporate quality and regulatory affairs, Thoratec Corporation
Joyce H. Williams, RAC, principal consultant, ProFocus Regulatory Solutions
Masters of Our Domain: Furthering the Regulatory Education of Busy Regulatory Professionals and the Development of a Top Notch Regulatory Staff
Professional Levels: II, III, IV
3:30 - 5:00 pm | Room 310
Professional development in the evolving regulatory field is crucial, not only for individual advancement but also for the potential impact on both consumers and industry. With the increasing availability of courses and classes, regulatory professionals struggle to find time for continuing education opportunities.
This session will guide you on how to “professionally” develop top notch regulatory staff in your company.
Session Leader:
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLC
Speakers:
Salma Michor, PhD, RAC, independent regulatory consultant, Michor Consulting
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLC
John F. Worzalla, RAC, MS, senior regulatory consultant, pharmaceutical regulatory services, The Anson Group LLC
TUESDAY, 16 SEPTEMBER
Regulatory Affairs Career Options: Finding the One That’s Right for You
Professional Levels: I, II
11:00 am - 12:00 pm | Room 312
Regulatory professionals can choose from a variety of career paths. Understanding the opportunities and challenges associated with different regulatory roles is important in career management and professional development.
In this session, you will learn about the most common opportunities in the field––individual contributor (specialist), manager, consultant and regulator. This overview and panel discussion will focus on the skills and experience needed for each position, how far each position can take you, how to decide which role is right for you or if a change in role would be advantageous, and what development experiences are important in achieving success in each role.
Session Leader:
Patricia R. Anderson, RAC, vice president, regulatory services, Canreg Inc.
Speakers:
Courtney C. Harper, PhD, associate director for toxicology, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Devices Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration
Diana K. Salditt, distinguished regulatory advisor, corporate regulatory, Medtronic Inc.
Beth Silverstein, RAC, director, SciLucent Inc.
Susan B. Stewart, RAC, senior vice president, regulatory affairs, Transmolecular Inc.
Communication Practices With Worldwide Regulatory Agencies: North America and Europe
Professional Levels: II, III, IV
1:30 - 3:00 pm | Room 312
Regulatory professionals need to remain flexible to maintain good communication practices with worldwide regulatory agencies.
This session offers you an overview of quality communication techniques and practices for the US, Canada and EU from industry and agency perspectives.
Session Leader:
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLC
Speakers:
Paul Kuiken, general manager, Pharmalink Consulting Inc.
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLC
Communication Practices With Worldwide Regulatory Agencies: Non-ICH Regions and Japan
Professional Levels: II, III, IV
3:30 - 5:00 pm | Room 312
Regulatory professionals need to remain flexible to maintain good communication practices with worldwide regulatory agencies.
This session offers an overview of quality communication techniques and includes presentations on good communication practices for Japan and non-ICH regions from industry and agency perspectives.
Session Leader:
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLC
Speakers:
Eileen McCall, PhD, associate director, intercontinental regulatory affairs, Eli Lilly and Company
Akio Onishi, MBA, vice president, government and industry affairs, Medtronic Japan Co. Ltd.
Yuka Suzuki, PhD, office director, Office of Medical Devices, Pharmaceuticals and Medical Devices Agency
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLC