戻る Agenda
Session 3B: Tools and Technology Track - Ensuring Global Readiness for the ISO IDMP Standards
Session Chair(s)
Andrew Marr, PHD
Managing Director
Marr Consultancy Ltd, United Kingdom
By 2016, XEVMPD will transition from the 39 fields currently required to more than 120 fields required by ISO IDMP. Additional supporting documents will be required to be submitted. The FDA and other Health Authorities will require submissions based on these standards. This session will cover the steps to ensure global readiness.
Speaker(s)
Presenter
John Kiser, MSC
Kiser Regulatory Services, United States
Principal
Presenter
Vada Perkins, DRSC, MSC
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Presenter
William Mandarino, MSC
UCB, Inc., United States
Associate Director, Product License Knowledge Management