With the huge uptake in personalized medicine globally, more and more device and drug companies are making companion diagnostics (CDx) products and wanting to know how to register these products. CDx helps determine which drugs will be effective for each patient. While CDx registration is now more established in the West, it is developing in Asia, too. Some Asian countries like Japan, Korea, China, and Australia have new CDx registration requirements, while other Asian countries are just beginning to familiarize themselves with CDx.
This online workshop will cover the key factors for the registration and reimbursement of CDx products and introduce attendees to the best CDx strategies to succeed in Asia.
Registration Fees & Deadlines
July 7, 2023 - January 13, 2023: Early Bird $150 Member | $175 Nonmember
January 13, 2023 – February 13, 2023: Regular $175 Member | $200 Nonmember
Learning Objectives
- Learn how to register CDx products in Japan and other Asian markets - How to get reimbursement for your CDx in Japan and other Asian markets
- Other factors to consider when launching CDx products in Asia
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher-level activities
Who Should Attend?
Medical Device and IVD regulatory executives, Drug regulatory executives, Medical Device, IVD, and drug reimbursement executives, and R&D executives in the CDx space
Speaker
Ames Gross
President, Pacific Bridge Medical
Ames Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with Asian business development and regulatory issues. He is recognized nationally and internationally as an Asian market expert. In 2008, “Medical Device and Diagnostic Industry” magazine named Gross one of the top 100 executives in the medical business. He is a frequent contributor to articles on Asian medical issues for that publication and other medically-oriented journals. He has been a featured speaker on the Asian medical markets at medical design and manufacturing shows, the Medtrade Home Health Care Exhibition, RAPS Convergence, and a variety of other medically oriented meetings and conferences. Gross is a University of Pennsylvania Phi Beta Kappa and holds an MBA from Columbia University.
Russell Henderson
Senior Director of Regulatory Affairs, Myriad Genetics, Inc
Mr. Russell Henderson is the Sr. Director of Regulatory Affairs at Myriad Genetics, Inc. In the past 9 years he has managed the registration of Myriad’s products in the U.S., Japan, and most recently Europe. This included the first approval of an LDT as a CDx by the U.S. FDA and Japan’s MHLW. He leads the regulatory efforts for Myriad’s CDx products globally. Russell has worked at Myriad for 17 years and obtained multiple certifications including SSBB, CQE and PMP throughout his professional career. He has a BS in Mechanical Engineering and a MS in Engineering Management from Washington State University.
Cancellation and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant, and the contact information for the new attendee.
Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org