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Título: Pharmaceutical research on children in Germany
Autor(es): Bernd-Rüdiger Kern
Notas: Comunicação apresentada na IV EAHL Conference on European Law and Patient Safety, Coimbra (9-11 October, 2013)
Resumo: I. Introduction. II. The basic decisions of the German Medicinal Products Act. 1. The balance between benefits and risks. 2. Groups of cases. III. Research on minors.1. Objective conditions. a) Indicated medical treatment (§ 41 sec. 2 s.1 nr. 1 AMG). b) Relative indicated medical treatment (§ 40 sec. 4 AMG). c) Non-indicated treatments: benefit to the group of patients (§ 41 sec. 2 s. 1 nr. 2 AMG). 2. Medical information and consent. a) Consent. b) Medical information. IV. Conclusion
Publicado em: In: Lex medicinae. - Coimbra : Coimbra Editora. - ISSN 1646-0359. - N.º Especial (2014), p. 243-248
Assuntos: Medicina | Investigação farmacêutica | Medicamento | Criança | Ensaio clínico | Alemanha
Veja também: Kern, Bernd-Rüdiger
Outros recursos:
Localização: PP.245 (CEJ)