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.
The Asia Pacific Device Summit is the world’s premier medical device conference for companies wishing to successfully launch products and magnify their impact in the Asia Pacific region.
The 2019 edition of the event attracts the industry's leading experts and authorities in Asia Pacific medical devices, research and regulatory affairs to discuss and debate the unique trends and challenges of our exciting, fast-paced industry.
BROUGHT TO YOU BY:
Successfully register medical devices in theAsia Pacific region
Optimise your revenue
Manage product distribution more efficiently
Get expert insight to inform your strategy
Gain a strong understanding of the reimbursement opportunities
Learn from experts in the field
Get best-practice tools and advice for ensuring a powerful launch
Market your products and brands effectively
Enhance regional operations
Amplify your local influence, strategic direction and cultural fit
Gain exclusive, insider information and insight into country-specific markets
In particular, the complex Chinese market
Explore ground-breaking industry research
Access the latest scientific knowledge to give your business a leg up
Share experiences, ideas and challenges
Network with regional decision makers and thought leaders
Discuss and debate the major issues in APAC
Stay ahead of the competition and keep up-to-date with industry trends and challenges
Connect with local experts from throughout the Asia Pacific
Explore business partnering opportunities for decision makers and investors
Understand the implications of the EU-MDR within the Asia Pacific marketplace
Find out how new developments impact your organisation
Learn about drug registrations in the rigorous Australia and New Zealand markets
Ensure compliance across the region
Set your company up for a healthy, long-term operation
Get the essential tools, tips and advice your need to succeed in the Asia Pacific market
Europe Agenda
8:30 |
Registration |
9:00 - 9:15 |
Opening Remarks – Cultural Challenges and Market Access Danielle Giroud, MD Clinicals |
9:15 - 10:00 |
Regulatory update on South Korea |
10:00 - 11:15 |
Implementation of AMDD (Asian Medical Device Directive) - an update Fiametta Soenardi, Sixmurs Group |
11:15 - 11:45 |
Coffee Break |
11:45 - 12:30 |
Taiwan Regulatory Perspectives Brandwood CKC |
12:30 - 14:00 |
Lunch |
14:00 - 14:45 |
Update on ASEAN Country Requirements Fiametta Soenardi, Sixmurs Group |
14:45 - 15:30 |
Getting your Device on the India Market Naresh Pagdimarry, 8C Healthcare |
15:30 - 16:00 |
Coffee Break |
16:00 - 16:45 |
Update on Requirements for China Market Access Brandwood CKC |
16:45 - 17:00 |
Panel Discussion |
17:30 |
Networking Cocktails |
8:30 |
Registration & Coffee |
9:00 - 9:30 |
Registration Requirements in Japan |
9:30 - 10:00 |
Bringing your product to the market downunder - an update on Australia and New Zealand Brandwood CKC |
10:00 - 10:30 |
Clinical investigation opportunities in Australia Brandwood CKC |
10:30 - 11:00 |
Coffee Break |
11:00 - 11:45 |
Registration process in the Middle East |
11:45 - 12:30 |
Be Euristic, Engage in Globalization of Clinical Data Danielle Giroud, MD Clinicals |
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 |
14:45 - 15:30 |
Conducting clinical investigations in China Danielle Giroud, MD Clinicals |
15:30 - 16:15 |
How to value your CE-mark in other markets Danielle Giroud, MD Clinicals |
16:15 - 17:00 |
Panel discussion and closing remarks Danielle Giroud, MD Clinicals |
USA Agenda
8:00 |
Breakfast and registration |
9:00-9:15 |
Introduction and Welcome Grant Bennett, Brandwood CKC |
9:15-10:00 |
Taking your 510(k) Down Under - Australia's Reliance model of regulation. Australia has developed a reliance model of regulation which leverages international reviews and is strong on international harmonisation. Explore TGA's streamlined Australian registration pathway for devices and IVDs already approved in US, Europe, Japan or Canada and requirements in key areas including software, UDI, clinical evidence and postmarket reporting. Terrance (T.J.) Thiel, Brandwood CKC |
10:00-10:45 |
China - managing the complexity China's NMPA continues frequent and incremental updates to regulations and practice. Clinical data remain at the forefront of regulatory review, with clinical trials mandated unless formally exempted, and a very cautious opening of the door to international clinical trial data. China is following Europe's lead on postmarket reporting and placing strict requirements on local representatives for active monitoring of postmarket feedback. We take a look at the latest developments in the Middle Kingdom and why strategy with flexibility is key to success. Jenny Lin, Brandwood CKC |
10:45-11:15 |
Morning Tea |
11:15-12:30 |
Secrets to Successful Medical Device Commercialisation in Australia Understand what makes Australia an attractive market for medical devices, gain insights into some of the key considerations for market entry and how to optimise your Australian market entry strategy for success. Kirsty Amland, Meta Medtech |
12:30-1:15 |
Considerations for Regulatory and Commercialisation Requirements in Asia Pacific: An IOL Case Study Japan's hybrid model combines detailed PMDA review of high risk devices with third party assessment of medium risk Class II devices. This presentation looks at the practical requirements for Japanese approvals. Randall May, Randall May & Associates, Inc. |
1:15-2:15 |
Lunch |
2:15-2.35 |
New Zealand rewrites the book on devices regulation New Zealand is undertaking a root and branch reform of regulation with a complete rewrite of the 1981 Medicines Act. The new legislation introduces completely new devices regulations, which accept international reviews and toughens up postmarket requirements. Terrance (T.J.) Thiel, Brandwood CKC |
2:35-3:00 |
Conducting clinical investigations in China China's formidable health care infrastructure provides many opportunities for clinical studies, but understanding the processes and local practices are essential to success. Danielle Giroud, MD Clinicals |
3:00-3:15 |
Afternoon Tea |
3:15-4:00 |
Update on ASEAN countries requirements ASEAN continues a steady expansion of the ASEAN Medical Devices Directive, with early implementation in Singapore and Malaysia now being followed by new regulations in Indonesia, Thailand and others. We look at the current progress. Brandwood CKC |
4:00-5:00 |
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 |
8:30-9:00 |
Breakfast and partner introductions Paul Smith - SBA Maryavis Bokal - Department of Commerce |
9:00-9:45 |
Be euristic, engage in globalisation of clinical data – success stories Danielle Giroud, MD Clinicals |
9:45-10:30 |
Unlock the New Opportunities in India in 2020 India's economy is now larger than France and the United Kingdom and it has launched the world's most ambitious health insurance program covering 500 million citizens. At the same new the new medical device rules will cover ALL medical devices starting April 1, 2020. How can foreign companies thrive in this turbulent market growing at over 15 percent per year? Gunjan Bagla, a seasoned India hand, leads Amritt's India medical device practice and will share a practical overview of medical device registration in India as well as his company's tips on how to succeed in India. This is an interactive session with plenty of time for your questions. Gunjan Bagla, Amritt Inc |
10:30-11:00 |
Morning Tea |
11:00-11:45 |
Australian clinical research sector update Australia has sophisticated heath care sytems and a well defined and light touch regulation of clinical trials which make it an ideal venue for early stage studies of advanced therapies. This presentation will describe the current regulatory frameworks including TGA's pilot of clinical trial audits. Stefan Czyniewski, Mobius Medical |
11:45-12:30 |
Taiwan - a predictable pathway? Taiwan's new Medical Devices Act remains stalled in parliamentary review. Meanwhile Taiwan FDA operates a unique process - driven, regulatory pathway with separate considerations of Quality Certification and product registration. It's not fast but advance planning and understanding how all the parts fit together can deliver predictable outcomes. Jenny Lin, Brandwood CKC |
12:30-1:00 |
Lunch |
1:00-1:45 |
Australian Reimbursement - Prosthesis Listing, Pricing and Evidence Australia's unique reimbursement model for implantable devices continues to be in the spotlight, with continuing reforms on pricing and scope. We look at the early steps in extension of the scheme to non-implants and the evidence required for the all important Prosthesis Listing. Sarah Griffin, Medtechnique Consulting |
1:45-2:30 |
Combination devices - medical devices incorporating medicines Brandwood CKC |
2:30-3:00 |
Afternoon tea |
3:30-4:15 |
Keynote: Global medical device regulations With so many jurisdictions each having local requirements and different cultures and practices, clear process and planning are essential to manage a global compliance portfolio. This session describes how to develop a global strategy with regulation as a key input, and how to pull it all together from half a world away. Grant Bennett, Brandwood CKC |
4:15-5:00 |
Panel discussion |
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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:
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