Tentative Agendas for the AHWP Hong Kong Meeting (4-7 November 2009)

                                                               
 

Start Date: 03-07-2009
End Date: 07-11-2009

Tentative Agendas for the AHWP Hong Kong Meeting (4-7 November 2009)
 

9th AHWP TC Meeting (4 Nov 2009)

  • Welcome Address by AHWP TC Chair
  • Adoption of Agenda
  • Roll-call
  • Progress Report by WG and STG :
    • WG1 : Pre-Market Submission and CSDT
    • WG1a : In-vitro Diagnostic Device
    • WG2 : Post-Market Surveillance and Vigilance
    • WG3 : Quality Management System
    • WG4 : Quality System Audit
    • WG5 : Clinical Evidence Requirements
    • WG6 : Capacity Building and Regulatory Training
    • STG(LE): AHWP Legal Entity
    • STG(N): Medical Device Nomenclature
  • Revised Terms of reference
  • Establishment of AHWP Ltd.
  • Selection of Medical Device Nomenclature
  • Comparative Study on Regulatory Frameworks
  • Any Other Business  

Workshops (5 Nov 2009)

Theme: Medical Device Regulatory Requirements, Compliance and Harmonization (Speakers and Topics to be Confirmed)

14th AHWP Meeting (6-7 Nov 2009)

  • Opening Ceremony
    • Welcome Remarks by Hosts of the 14th AHWP Meeting
    • Opening Remarks by AHWP Chair
  • Welcome Address by AHWP Chair
  • Adoption of Agenda
  • Roll-call
  • Confirmation of the Report of the 13th AHWP Meeting
  • Matters arising from the 13th AHWP Meeting
  • Updates from AHWP TC
  • AHWP Work Plan and Targets
  • Resolution 1: Adoption of New Terms of Reference
  • Resolution 2: Establishment of AHWP Ltd.
  • Election of Directors and Office Bearers of AHWP Ltd.
  • Resolution 3: Selection of Medical Device Nomenclature System
  • AHWP-GHTF Collaboration
  • Update from GHTF Study Groups
  • AHWP-WHO Collaboration
  • AHWP-APEC Collaboration
  • Any Other Business

 

Attachment(s):
 Download file:Tentative_Agendas_for_the_AHWP_Hong_Kong_Meeting_4_7_November_2009.pdf