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INTERNATIONAL HARMONISATION: GLOBAL REGULATORS’ PROGRESS FROM GHTF TO IMDRF - ARE WE ANY NEARER TO REGULATORY CONVERGENCE?
Session Chair(s)
Sinisa Tomic, PhD
Counsellor for European Affairs
Croatian Medicines Agency, Croatia (Hrvatska)
Regulating Medical Devices in the Pre-Accession Period
Learning Objective : Participants will learn about the placement of medical devices in croatia in the pre-accession period. Furthermore, they will learn about the harmonisation process of the national legislation and the transposition of new approach directives.
Speaker(s)
Latest News from the International Medical Device Regulators Forum and Future Goals: IMDRF
Mike Ward
World Health Organization (WHO), Switzerland
Coordinator, Regulatory Systems Strengthening, EMP
How Industry Is Working to Make its Voice and Priorities Heard at the Global Regulatory Level
Sabina Hoekstra-van den Bosch, PharmD, MSc, RPh
Tüv Süd, Netherlands
Regulatory Strategy Principal
Regulating Medical Devices in the Pre-Accession Period
Sinisa Tomic, PhD
Croatian Medicines Agency, Croatia (Hrvatska)
Counsellor for European Affairs
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