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Minneapolis Marriott City Center
Minneapolis
9–10 June 2008
 Program Description
This program addresses the complexities companies face when introducing a Medical Device or IVD product onto the Japanese market. This program gives professionals a roadmap with related knowledge and real-life examples of what is required for regulatory clearance including: Quality Management System (QMS) and preapproval audits, JIS standards, Shonin and Summary Technical Document (STED) requirements, Third Party Review bodies, Marketing Authorization Holders (MAHs) and various clinical aspects. This program benefits professionals working in small to mid-size companies that are currently introducing or anticipate introducing a Medical Device or IVD product onto Japan’s market. Presenters address key challenges and provide useful advice for overcoming hurdles throughout the regulatory introduction and clearance process. This program includes lectures, a panel discussion and question and answer forums.
Learning Objectives Upon completion of this session participants will learn:
- The evolution of the Pharmaceutical Affairs Law (PAL) and its regulatory agency
- Quality Management System (QMS) and preapproval audits
- Commonly cited submission deficiencies
- Available Japan Industrial Standards (JIS)
- Third Party Review bodies: who they are and how to choose one appropriate for each product
- How to locate a Marketing Authorization Holder (MAH) and the pros and cons of the selection process
- Pros and cons of using a distributor
- How to conduct clinical trials in Japan
- Clinical trial data review process
- STED (Summary Technical Document)
Who Should Attend?
Mid-level regulatory professionals from small, mid to large-size companies working in the following medical device and IVD regulatory areas:
- Clinical
- Submission
- Registration
- Manufacturing
- Distribution
- Reimbursement
- Postmarket
Levels: II, III
Confirmed Speakers
- Amy Allen , Senior Project Manager, Iverson Language Associates, Inc.
- Jodi Boerner, International Trade Representative–Healthcare Industry, Minnesota Trade Office
- David Ikeda, Staff Regulatory Specialist, Beckman Coulter, Inc.
- Jennifer Kocs, International Trade Representative, Minnesota Trade Office
- Yuliya Matlin, Senior Global Regulatory Affairs Associate, Hospira, Inc.
- Yuliya Matlin, Senior Global Regulatory Affairs Associate, Hospira, Inc.
- Yoshio Mitsumori, President & CEO, ADMIS, Inc.
- Sue Norenberg, Senior Principal Regulatory Compliance Consultant, Medtronic Inc.
- Seiko Ohyama, Lead Engineering Associate, Medical Section, Operations Division, Underwriters Laboratories
- Scott Sardeson, RAC, International Regulatory Manager, 3M Company
- Hiroshi Takagi, DVM, MS and PhD, Corporate R&D Liaison, Baxter
- Yuko Takahashi, Senior Regulatory Associate, Abbott Vascular
- Chip Whitacre, Senior Director, Corporate Operations, Medtronic Inc.
- Keijiroh Yama-Guchi, English/Japanese Interpreter
View speaker bios
Program Chairs
Susumu Nozawa, RAC, Corporate Regulatory Affairs, Becton Dickinson
Chip Whitacre, Senior Director, Regulatory Operations, Medtronic |