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THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
Session Chair(s)
Wolfram Hildebrandt, MA, MSc
Head of Health Technology Assessment, Head of Pharmacovigilance
PharmaLex GmbH, Germany
How Will Health Technology Assessment Interface with Pharmacovigilance in a Pharmaceutical Company and in a Regulatory Agency?
Learning Objective : 1) Understand how assessing data for regulatory post authorization studies will align with the aims of health-technology assessment real life studies 2) Discover what synergies can be created if real life studies where coordinated between HTA bodies and regulators
Speaker(s)
HTA and Pharmacovigilance Data in the Changing World of Regulations
Wolfram Hildebrandt, MA, MSc
PharmaLex GmbH, Germany
Head of Health Technology Assessment, Head of Pharmacovigilance
How Will Health Technology Assessment Interface with Pharmacovigilance in a Pharmaceutical Company and in a Regulatory Agency?
Thomas Lönngren, PharmD
NDA Group, Sweden
Strategic Advisor
The Impact of the New Pharmacovigilance Practice on HTA
Adam Przybylkowski
Medical University of Warsaw, Poland
Associate Professor Department of Clinical and Experimental Pharmacology
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