- Upon completion, participant will be able to describe what are the green pathways, and list criteria and requirements of innovation pathway.
- Upon completion, participant will be able to define the innovation special review dossier process and implement the advantages and considerations of fast-track channel in their real practice.
- Upon completion, participant will be able to accelerate go-to-market strategy by implementing the benefits of innovative products in VBP, pricing and reimbursement.
Who Should Attend?
- Clinical affairs professionals
- Managers in the life sciences industry
- Regulatory affairs professionals
- Quality affairs professionals
- Medical affairs professionals
- R&D managers
- Compliance managers
- Operations managers
- Marketing and business executives
- Chief financial and commercial managers
Audience Learning Level
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Agenda
Day 1
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8:30 am – 9:00 am
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Welcome, introduction of speakers & schedule
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9:00 am – 10:00 am
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FDA Part 1: Overview Of Programs, Breakthrough Device
Designation, EUA
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10:00 am – 10:15 am
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BREAK
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10:15 am - 11:30 am
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FDA Part 2: Humanitarian Use, Combination Products, And Other
Special Programs
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11:30 am – 12:30 pm
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EU: regulations and practices
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Day 2
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8:30 am – 9:30 am
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Canada and Australia: Overviews and special programs
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9:30 am – 10:30 am
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S. Korea: Medical Device Regulations and special programs (speakers in Korea)
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10:30 am – 10:45 am
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Break
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10:45 am – 12:00 pm
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Q&A and Panel Discussion
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Day 3
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8:30 am – 9:45 am
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China: Innovative track, priority review, regional policies
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10:00 am – 11:15 am
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Japan Part 1: Market Overview and Regulatory System
Japan Part 2: Japan Reimbursement System
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9:45 am – 10:00 am
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BREAK
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11:15 am – 12:15 pm
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Japan Part 3: Japan Expedited Approval Options
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12:15 pm – 12:30 pm
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Q&A and Panel Discussions
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***Agenda is subject to change
Speakers
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.
Cancellations 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.
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
RAPS@raps.org