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How to Build Regulatory Roadmap for Your Medical Startup
October 23, 2021 @ 9:00 pm - 10:30 pm
About this event
The biggest challenge awaiting startups in medical and healthcare is how to meet the regulatory requirements. Startup companies generally do not possess the systems and knowledge to manage the entire development process within regulatory frameworks. In this event, AAIA invites industry experts to tackle this challenge by discussing the strategic roadmap and tactics for medical innovations on high level.
The speakers are:
- Ellen Jiang, MD — General Manager, Ramed (Beijing) Medical Technology Co.,Ltd. A company of Pharmaron
- Ruimei Linda Li , MD., MPH, PHD — CEO, GCP Clinica Service
The moderator is:
- Morgan Guo, Ph.D — VP Membership, AAIA
Topics of discussion include:
- Understanding key factors for successful pre-clinical and clinical planning
- Basic CMC requirements for pre-clinical therapeutics
- Clinical trial package essentials
- Tactics on how to navigate different regulatory frameworks in US, EU and China
- NMPA (Chinese FDA) registration approaches for medical device
- Regulatory cases — COVID related diagnostic products
- Entrepreneurs in medical and life sciences domain
- Medical startup company employees
Saturday, October 23, 2021 (North America)
9:00 – 10:30 pm EDT
7:00 – 8:30 pm MDT
6:00 – 7:30 pm PDT
Online event. The event link will be emailed to you 24 hours before the event starts.
This event will be delivered in Mandarin.