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20sep12:00 pm1:00 pmLeveraging FDA’s Expedited Programs to Accelerate Product DevelopmentWebinar
Event Details
Accelerating the development of therapeutic products intended to treat serious conditions has been an interest of the public, legislators, and the scientific community for many years. Responding to this interest, the
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Event Details
Accelerating the development of therapeutic products intended to treat serious conditions has been an interest of the public, legislators, and the scientific community for many years.
This webcast will highlight the requirements, benefits, and procedures for Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. We will also discuss two newer programs, Regenerative Medicine Advanced Therapy (FDA guidance, Feb 2019) and Qualified Infectious Disease Program (FDA guidance, Jan 2018). This webcast will also describe the importance of establishing a therapeutic area as a serious condition with unmet medical need for each of these programs and provide examples for this.
Webinar Overview:
Title: Leveraging FDA’s Expedited Programs to Accelerate Product Development
Date: Friday, September 20, 2019
Time: 12:00-1:00 M Eastern Daylight Time
Register for this Complimentary Webinar Now (you will be brought to the Xtalks website for registration)
Time
(Friday) 12:00 pm - 1:00 pm
25sep1:30 pm3:00 pmSouth San Francisco Transportation Workshop
Event Details
Join us as Biocom's Bay Area Facilities/EH&S Committee hosts a workshop on public transit and other changes coming to the City of South San Francisco! City Manager Mike Futrell will
Event Details
Join us as Biocom’s Bay Area Facilities/EH&S Committee hosts a workshop on public transit and other changes coming to the City of South San Francisco! City Manager Mike Futrell will join us to discuss:
- Community Facility District
- The new Caltrain station and its services
- Caltrain electrification
- South San Francisco general plan
- Future potential housing developments
Time
(Wednesday) 1:30 pm - 3:00 pm
26sepallday27alldayBIOBASICS: BIOTECH FOR THE NON-SCIENTISTtwo-day course
Time
september 26 (Thursday) - 27 (Friday)
26sep5:00 pm8:00 pmFeaturedChina’s Life Science Market: The Latest Developments and Trends
Event Details
Join us as we hear from industry KOLs on the latest developments and trends in the China life science market. The panelists, representatives of companies developing drugs in China and
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Event Details
Join us as we hear from industry KOLs on the latest developments and trends in the China life science market. The panelists, representatives of companies developing drugs in China and collaborating with Chinese partners, and professional practitioners in the field, will discuss the latest developments in the biotech industry in China and share their own experiences on a range of topics, including:
- Current state of the drug and device approval process, including timing, in China
- Partnering in China for R&D and product development
- Update on IP protection in China and strategies to protect your own IP
- Accessing capital from China-based investors for R&D outside China
- Pre-revenue biotech listings in Hong Kong – where are we now?
- General tips on doing business vis-à-vis US-China relations today
Time
(Thursday) 5:00 pm - 8:00 pm
