Boston Chapter and ASQ New England Discussion Group of the Biomedical Division : China Food and Drug Administration (CFDA) Update

RAC Credits
Wednesday, 24 October 2018 (3:00 PM) - Wednesday, 24 October 2018 (7:00 PM)
860 Winter St
Waltham, Massachusetts, USA, 02451-1449

Wednesday, 24 October 2018
3:00-7:00 pm EST
The Conference Center at Waltham Woods
860 Winter Street
Waltham, MA 02451
+1 781 437 7499

Don’t miss this unique opportunity to engage with regulatory and quality colleagues from your region for an in-depth exploration of major restructuring at the China Food and Drug Administration (CFDA.) O
ur esteemed speaker, subject matter expert, Grace Fu Palma, just returned from a CFDA meeting in China. She will provide an overview of major restructuring at CFDA and other 2018 updates. This half-day program will include three sessions, each targeted to regulatory, quality and CRO professionals.

Scheduled presentations include: 

  • CRO Update: Overview of Recent Clinical Requirement Changes and Looking Ahead to 2019
    • Clinical Evidence Requirements
    • Clinical Trial/Evaluation
    • International Clinical Data
    • Multi-Center Trial
  • Quality Update:   QMS and Post-market Compliance Changes
    • Overseas Inspections
    • Summary of History Lessons
    • Tips and Processes to Prepare for Oversees Inspections
  • Regulatory Update: Pathways to Foreign Companies 
    • Innovation, Special Zones and Type Testing
    • Legal Registration Holder vs. Contract Manufacturing
    • Acceptable International Reports vs. Mandated Local Testing

This event is brought to you through a collaborative effort from the RAPS Boston chapter and the ASQ New England Discussion Group of the Biomedical Division, and is intended to encourage knowledge sharing and community development among regulatory and quality professionals in the New England region. A full dinner buffet will be provided for all attendees. Attendees can claim four RAC recertification credits or 0.5 ASQ RU/CEUs.

Featured speaker:
Grace Fu Palma, MBA, CEO, China Med Device

Registration information:
Prior to 17 October:
RAPS and ASQ Members*:  $85
Nonmembers:  $105

On or after 17 October:
RAPS and ASQ Members*:  $100
Nonmembers:  $120

*ASQ members, contact Pamela Goldstein for a registration discount code.

Thank you to our program sponsor, Whitney Consulting.