The 11th AHWP Meeting, 13th - 15th September 2006 - Pre-Meeting Workshop Presentations


                                                      
 

A two-day Pre-meeting Workshop will be held on Wednesday, 13 September 2006 and Thursday, 14 September 2006 in conjunction with the Meeting. The Pre-Meeting Workshop is designed as an educational as well as information exchange forum on medical devices and medical devices regulatory requirements. Various pertinent topics relating to medical devices, medical devices regulatory system and efforts towards global harmonization of the regulatory system will be presented by internationally renowned experts. The topics to be covered include Conformity Assessment Procedure, STED, GMDN, Combination Products, Risk Management, Clinical Trials, Quality System; and Vigilance Reporting System.

AHWP Pre-Meeting Workshop Presentations
A two-day Pre-meeting Workshop will be held on Wednesday, 13 September 2006 and Thursday, 14 September 2006 in conjunction with the Meeting. The Pre-Meeting Workshop is designed as an educational as well as information exchange forum on medical devices and medical devices regulatory requirements. Various pertinent topics relating to medical devices, medical devices regulatory system and efforts towards global harmonization of the regulatory system will be presented by internationally renowned experts. The topics to be covered include Conformity Assessment Procedure, STED, GMDN, Combination Products, Risk Management, Clinical Trials, Quality System; and Vigilance Reporting System.
Please download the presentations below...

Attachment(s):

Download file:Plenary_Session_I__Towards_Global_Harmonization__EU_Perspective.pdf 
 
Download file:Plenary_Session_II__Adoption_of_the_Summary_Technical_Documentation_STED.pdf 
 
Download file:Plenary_Session_III__Adoption_and_Implementation_of_STED_in_Japan_Part_1.pdf 
 
Download file:Plenary_Session_III__Adoption_and_Implementation_of_STED_in_Japan_Part_2.pdf 
 
Download file:Plenary_Session_V__Implementing_Risk_Management_To_Your_Advantage.pdf 
 
Download file:Plenary_Session_VI__Implementing_Risk_Management_To_Your_Advantage.pdf 
 
Download file:Plenary_Session_VII_How_to_Adopt,_Adapt_and_Implement_GHTF_Recommendations_for_Countries_Developing_Regulations_In_Asia.pdf 
 
Download file:Plenary_Session_VIII__Practical_Issues_in_Drug_Device_Combination_Products.pdf 
 
Download file:Workshop_III__Surviving_an_FDA_Inspection__An_Industry_Perspective_Session_2.pdf 
 
Download file:Plenary_Session_X__The_Need_for_Global_Medical_Device_Regulations_to_Safeguard_Public_Health__Global_Trends.pdf 
 
Download file:Workshop_I__U.S._FDA_Clinical_Inspection___An_Industry_Experience.pdf 
 
Download file:Workshop_III__Surviving_an_FDA_Inspection__An_Industry_Perspective_Session_1.pdf 
 
Download file:Workshop_IV__Ensuring_the_Safety_of_Marketed_Medical_Devices___Vigilance_Reporting_System_Session_1.pdf 
 
Download file:Workshop_IV__Ensuring_the_Safety_of_Marketed_Medical_Devices___Vigilance_Reporting_System_Session_2.pdf