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How to Build Regulatory Roadmap for Your Medical Startup

October 23 @ 9:00 pm - 10:30 pm

Our speakers with significant experience in clinical trial planning and regulatory will discuss how to work towards regulatory clearance

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

Targeted audience:

  • Entrepreneurs in medical and life sciences domain
  • Medical startup company employees

 

Time:

Saturday, October 23, 2021 (North America)

9:00 – 10:30 pm EDT

7:00 – 8:30 pm MDT

6:00 – 7:30 pm PDT

 

Location:

Online event. The event link will be emailed to you 24 hours before the event starts.

 

Language:

This event will be delivered in Mandarin.

Organizer

AAIA
Email:
register@aaiatech.org
View Organizer Website