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Two great events. Five Billion Opportunities.

EUROPE

MAR. 7-8, 2019

Frankfurt, Germany

USA

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:

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Business & Regulatory

Discover how you can optimize revenue by planning early and include Asia Pacific in your global market access for your medical devices.

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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.

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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

Thursday, March 7
Friday, March 8
Thursday, March 7

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

Friday, March 8

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

Monday, March 25
Tuesday, March 26
Monday, March 25

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

Tuesday, March 26

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

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Register Now.

Registrations for the events will be available soon. Stay tuned!