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A Lenaers

Learning units :  
 

PHIN2029-2		Regulation and the medical-social environment			Holder
		-	Economic aspects of drug development
		-	Legislation and procedures applied to pharmaceutical industry, part a : legislation
		-	Legislation and procedures applied to pharmaceutical industry, part b : patents and protection
		-	Macroeconomic environment and pharmaco-economics
		-	CTD File (Common Technical Document)
		-	Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files
		-	Regulations of preclinical and clinical studies, part b : clinical studies
		-	Regulations of preclinical and clinical studies, part c : pediatric studies
		-	Specific regulatory issues, part a : medicine and herbal dietary supplement
		-	Specific regulatory issues, part b : Preformulation and galenical development documentation