MONDAY, 15 SEPTEMBER
Regulatory Hot Topics Overview: Asia
Professional Levels: II, III, IV
11:00 am - 12:00 pm | Room 311
China, India and Southeast Asia are among the hottest emerging markets for the healthcare products sector.
In this session, you will learn about the diverse and rapidly evolving regulatory structure and processes in these regions. Whether you are in one of these markets or considering gaining entry, participating in this session will give you knowledge of the benefits and barriers of operating within Asia’s challenging regulatory environments.
Session Leader:
Chang-Hong Whitney, MBA, president, Whitney Consulting Ltd.
Speakers:
Janet R. Kwiatkowski, RAC, MBA, manager, international regulatory affairs, Hologic Inc.
Munish Mehra, PhD, managing director, Global Drug Development Experts LLC
Chang-Hong Whitney, MBA, president, Whitney Consulting Ltd.
Global Harmonization: Fact or Fiction?
Professional Levels: II, III, IV
3:30 - 5:00 pm | Room 311
The Global Harmonization Task Force (GHTF), International Organization for Standardization (ISO) and International Conference on Harmonisation (ICH) are leading efforts to standardize requirements for healthcare products globally.
In this session, you will hear the latest updates on harmonization efforts and review the impact and benefits of these initiatives for regulated industry. Experts will discuss future implications of the harmonization efforts, which may or may not be adopted and implemented.
Session Leader:
Joel C. Kent, MS, RAC, manager, quality and regulatory affairs, GE Healthcare
Speakers:
Joel C. Kent, MS, RAC, manager, quality and regulatory affairs, GE Healthcare
Roland G. Rotter, PhD, director, Medical Devices Bureau, Health Canada
TUESDAY, 16 SEPTEMBER
Japan Regulatory and Reimbursement Update
Professional Levels: II, III, IV
11:00 am - 12:00 pm | Room 304
Japan’s healthcare product market is one of the largest in the world. To operate successfully in Japan, a strong understanding of its regulatory system is critical.
With a special focus on reimbursement issues, this session will provide you with a solid foundation of Japan’s medical device and pharmaceutical market, including information on the most recent regulatory issues.
Session Leader:
Joel C. Kent, MS, RAC, manager, quality and regulatory affairs, GE Healthcare
Speaker:
Akio Onishi, MBA, vice president, government and industry affairs, Medtronic Japan Co. Ltd.
Regulatory Hot Topics Overview: Canada and Latin America
Professional Levels: II, III, IV
1:30 - 3:00 pm | Room 311
This unique two-in-one session focuses on both the established healthcare products regulatory regime in Canada and the very diverse regulatory environment in the emerging region of Latin America.
In this session, you will learn about the structure and processes of regulatory agencies in Canada and select Latin American countries. You will gain knowledge of the benefits of operating within this ever-changing regulatory environment and obtain valuable tools to help your organization overcome barriers while working with these regions.
Session Leader:
Joel C. Kent, MS, RAC, manager, quality and regulatory affairs, GE Healthcare
Speakers:
Dennis P. Hurley, DrSc, vice president, Latin America, Kendle Servicios SA de CV Mexico
Roland G. Rotter, PhD, director, Medical Devices Bureau, Health Canada
Pharmaceutical Anti-Counterfeiting Strategies
Professional Levels: II, III, IV
1:30 - 3:00 pm | Room 313
Counterfeit pharmaceutical products constitute a multi-billion dollar industry and pharmaceutical companies must take measures to protect their products and profits.
In this session, you will learn strategies for operational security, new technologies, industry partnerships, supply chain management and cooperation with national and international agencies. These product protection approaches will ensure your company is prepared to safeguard its intellectual property, interests and investments.
Session Leader:
Simon Collier, senior manager, government relations, Eisai Co. Ltd.
Speakers:
Simon Collier, senior manager, government relations, Eisai Co. Ltd.
James A. Dahl, product security advisor, Eisai Co. Ltd.
Environmental Regulations: Impact on Drug Development and Product Stewardship
Professional Levels: II, III, IV
10:30 am - 12:00 pm | Room 313
A maze of environmental regulations and increasing global awareness surrounding pharmaceuticals in the environment affect the design, marketing and disposal of pharmaceuticals.
In this session, you will learn about current environmental regulations and requirements and how they impact the pharmaceutical industry. We will also explore initiatives toward “green pharmacy” and product stewardship models in the US, Europe and Canada. You will examine ethical considerations and take home practical approaches to maintaining compliance and environmental safety.
Session Leader:
Charlotte A. Smith, RPh, MS, HEM, president, PharmEcology Associates LLC
Speakers:
Mary L. Hendrickson, RPh, MBA, director, quality and regulatory affairs, Capital Returns Inc.
Charlotte A. Smith, RPh, MS, HEM, president, PharmEcology Associates LLC