Expedited Pathways (US/Global) – Medical Device

12.0
RAC Credits
Monday, 15 November 2021 (8:30 AM) - Tuesday, 16 November 2021 (4:15 PM) Eastern Time (US & Canada)

“How can we expedite the approval of our product?” this is the question every regulatory professional asks themselves daily.

Regulations shift continuously as result of changes in national and international, political, economic, and healthcare environments. As regulators around the globe observe and learn from each other, their policies evolve as the government agencies try to balance risks and benefits of their decisions. All this, while maintaining support of technology innovations, healthcare services for the population, and even for national security interests.

This workshop brings together experts from many different locations to discuss regulations in the US, EU, Canada, Australia, China, Japan, and South Korea. During this workshop we will explore special programs, policies and practices that these countries and regions have installed to foster adaption of new technologies, to address unmet clinical needs, and to respond to national health emergencies. The workshop will also feature corporate executives to discuss corporate strategies and market access, where regulatory is just a piece of a larger puzzle.

This workshop is aimed at providing the fundamentals that attendees can use as well as high-level perspectives that may shape a company’s business and regulatory strategies.


Pricing Amounts & Deadlines

18 November 2020 – 18 October 2021: Early Bird $800 Member | $900 Nonmember
19 October – 14 November 2021: Regular $900 Member | $1000 Nonmember

Agenda - Tentative

Day 1 – Monday, November 15, 2021

9:00 am ‐ 9:15 am Introductions and overview of class
9:15 am ‐ 9:25 am Keynote speaker
9:25 am – 10:30 am FDA Part 1: Overview of programs, breakthrough device, EUA
10:30 am – 10:45 am Break
10:45 am – 12:00 pm FDA Part 2: Humanitarian device, combination products, and other special programs.
    - Q&A
12:00 am – 1:00 pm Lunch
1:00 am – 2:30 pm EU: Regulations and practices
2:30 pm ‐ 2:45 pm Break
2:45 pm – 3:45 pm Canada and Australia: Overviews and special programs
    - Q&A
3:45 pm – 4:15 pm Q&A and Panel discussion

Day 2 ‐ Tuesday, November 16, 2021

8:30 am ‐ 10:30 am S. Korea: Medical Device Regulations and special programs (speakers in Korea).
    - Q&A
10:30 am ‐ 11:00 am Break
11:00 am ‐ 12:00 pm China: Innovative track, priority review, regional policies.
    - Q&A
12:00 pm‐1:00 pm Lunch
1:00 pm ‐ 2:30 pm Japan Part 1: Medical Device Regulations, HBD program, special committee review, recent developments
2:30 pm ‐ 2:45 pm Break
2:15 pm – 2:45 pm Japan Part 2: Reimbursement, market access, strategy. Q&A
2:45 pm ‐ 3:15 pm Guest speaker: Global strategies
3:15 pm ‐ 4:00 pm Q&A and panel discussions
4:00 pm End of Day 2 Workshop


Speaker 


Chang-Hong Whitney  RAC MBA
President & CEO, Whitney Consulting Ltd.

Chang-Hong Whitney has spent more than 30 years in the medical device industry in both China and the US. She founded Whitney Consulting Ltd., focusing on Chinese regulations for medical devices and IVDs, servicing exclusively international clients around the world, including Fortune 500 companies. Whitney is an active member of the RAPS community, presenting China regulatory updates at RAPS conferences, organizing workshops and seminars, editing educational material, and serving on volunteer committees. She holds an MBA from Babson College and undergraduate degrees in electrical engineering and international business in China.
  • TBD

Cancellation Policy

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.