Two great events. Five Billion Opportunities.
MAR. 7-8, 2019
Frankfurt, Germany
MAR. 25-26, 2019
Yorba Linda, California
COME MEET THE MEDICAL DEVICE EXPERTS FROM ASIA PACIFIC.
Join us for the 2019 edition of the Asia Pacific Device Summit with two exceptional events that will bring you face-to-face with local experts from Singapore, Jakarta, Sydney, Kuala Lumpur, and Beijing. Discover what it takes to successfully plan, implement and obtain successful medical device registrations and learn more about the implications of the EU-MDR within the Asia Pacific marketplace.
BROUGHT TO YOU BY:
Business & Regulatory
Discover how you can optimize revenue by planning early and include Asia Pacific in your global market access for your medical devices.
Clinical Evaluation
Can Asia be included in your global clinical investigations? Learn what data is needed to access Asia Pacific and more specifically, the Chinese market.
Make New Friends
Network with the experts during our cocktail session and make the most of your day at the Asia Pacific Device Summit!
Europe Agenda
8:30 |
Registration |
9:00 - 9:15 |
Opening Remarks – Cultural Challenges and Market Access Danielle Giroud, MD-CLINICALS, LAUSANNE, BEIJING, MALAYSIA |
9:15 - 10:00 |
Opportunities Down-under: Australia & New Zealand Requirements Arthur Brandwood, BRANDWOOD BIOMEDICAL |
10:00 - 11:15 |
Implementation of AMDD (Asian Medical Device Directive) - An Update Ellen Mendoza, SIXMURS GROUP |
11:15 - 11:45 |
Coffee Break |
11:45 - 12:30 |
Taiwan Regulatory Perspectives Arthur Brandwood, BRANDWOOD BIOMEDICAL |
12:30 - 14:00 |
Lunch |
14:00 - 14:45 |
Update on ASEAN Country Requirements Ellen Mendoza, SIXMURS GROUP |
14:45 - 15:30 |
Getting your Device on the India Market Naresh Pagdimarry, 8C HEALTHCARE PVT. LTD. |
15:30 - 16:00 |
Coffee Break |
16:00 - 16:45 |
Update on Requirements for China Market Access Arthur Brandwood, BRANDWOOD BIOMEDICAL |
16:45 - 17:00 |
Panel Discussion |
17:30 |
Networking Cocktail |
8:30 |
Registration & Coffee |
9:00 - 9:45 |
Registration Requirements in Singapore & Latest News on AHWP SIXMURS |
9:45 - 10:30 |
Japan Registration Process |
10:30 - 11:00 |
Coffee Break |
11:00 - 11:45 |
Registration Process in Middle East |
11:45 - 12:30 |
Be Euristic, Engage in Globalization of Clinical Data Danielle Giroud, MD-CLINICALS, LAUSANNE, BEIJING, MALAYSIA |
12:30 - 14:00 |
Lunch |
14:00 - 14:45 |
Clinical Investigation Data Needed for India Market Access and Conduct Clinical Trials in India Naresh Pagdimarry, 8C HEALTHCARE PVT. LTD. |
14:45 - 15:30 |
Conducting Clinical Investigations in China Danielle Giroud, MD-CLINICALS, LAUSANNE, BEIJING, MALAYSIA |
15:30 - 16:15 |
How to Value your CE-Mark in Other Markets BRANDWOOD BIOMEDICAL |
16:15 - 17:00 |
Panel Discussion and Closing Remarks |
USA Agenda
7:30 |
Breakfast |
8:30 |
Welcome and Introduction Arthur Brandwood, BRANDWOOD BIOMEDICAL |
8:50 |
Global Regulatory Reforms and the Asia Pacific: Are You Keeping Up? Grant Bennett, BRANDWOOD BIOMEDICAL |
9:30 |
The Challenges on Implementation of AMDD in ASEAN Region Hwee Ee Tan, DH REGSYS, SINGAPORE |
10:10 |
Morning Tea |
10:40 |
And We're Off! New Medical Device Rules 2017, India Launched January 1, 2018. How They'll Affect You! Naresh Pagidimarry, 8C HEALTHCARE PVT. LTD. |
11:20 |
In China Nothing Is as It Seems – Practical Understanding of China's Order 650 Medical Device Regulations Junhua Shang, BRANDWOOD BIOMEDICAL |
12:00 |
Lunch |
1:30 |
Using China’s Innovative Device Pathway Mr. Yongheng Chang, CHINA FOOD & DRUG ADMIN |
2:10 |
Getting Paid – the Shifting Reimbursement Landscape in Australia Sarah Griffin, BRANDWOOD BIOMEDICAL |
2:50 |
Afternoon Tea |
3:20 |
Introduction to U.S. Commercial Service Jim Mayfield, US COMMERCIAL SERVICE |
3:30 |
Panel Discussion: Summary - Pulling it all together |
4:00 |
Nixon Library Tour: take some time to have a look around the library after a busy first day. |
5:00 - 7:00 |
Networking and Cocktails |
8:00 |
Breakfast |
8:30 |
Globalization of Clinical Data – New Perspectives Danielle Giroud, MD-CLINICALS, LAUSANNE, BEIJING, MALAYSIA |
9:40 |
Taiwan Regulatory Perspectives Arthur Brandwood, BRANDWOOD BIOMEDICAL |
10:20 |
Morning Tea |
10:50 |
Conducting Clinical Trials in China Matthew Reabold, GEORGE CLINICAL |
11:30 |
Managing a Pan Pacific Product Portfolio. In House, or Outsource? Ed Woo, VARIAN MEDICAL SYSTEMS |
12:10 |
Lunch |
1:20 |
Introduction to the Medtech Directory Dan Golka |
1:30 |
Japan – Demystifying Regulation in One of the World's Largest Medtech Markets Arthur Brandwood, BRANDWOOD BIOMEDICAL |
2:10 |
Post-Market Compliance – Keeping Those Hard Won Registrations Grant Bennett, BRANDWOOD BIOMEDICAL |
3:00 |
Panel Discussion: Summary - Pulling it all together |
3:20 |
Hypothetical and Open Forum – Strategy, Commerce and Culture in the World's Fastest Growing Markets |
4:00 |
Close |
Europe Location
Museum für Kommunikation
Schaumainkai 53 – 60596
Frankfurt am Main - Germany
For more information, please contact us at: [email protected]
Brought to you by:
USA Location
The Nixon Library
18001 Yorba Linda Boulevard
Yorba Linda, California 92886
For more information, please contact us at: [email protected]
Brought to you by:
Register Now.
Registrations for the events will be available soon. Stay tuned!