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  • DIA: A Pioneer in Patient Engagement

  • Bayesian Case Studies

  • Electronic Document Management Reference Model

  • Framework for the Destruction of Paper

  • GMP Quality Systems Reference Model

  • Trial Master File Reference Model 3.0

  • Visual Model of Patient Engagement in Benefit-Risk Assessment through the Medical Product Life Cycle

14th DIA Japan Annual Meeting 2017

Tokyo Big Sight

PMDA’S Rational Medicine Initiative: Serving Patient Interests

By Tatsuya Kondo, MD, PhD; Chief Executive, PMDA Found in: Article, Regulatory Affairs

Throughout my clinical practice experience, I have always believed that medical care must be administered on the basis of the…

New EU Medical Devices & In Vitro Diagnostic Regulations

By Erik Vollebregt Found in: Article, Regulatory Affairs, Devices & Diagnostics

The EU Commission has just finalized the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The…