2001 20 ec pdf995

 

 

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Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 1. By means of the repeated inspections referred to in Article 111(1) of Directive 2001/83/EC and by means of the inspections referred to in Article 15(1) of Directive 2001/20/EC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive. 2 Proposal for a revision of the "Clinical Trials Directive" (2001/20/EC) and other recommendations to facilitate clinical trials | December 2011 Foreword Improvements in medical treatment can only be achieved through clinical research. Therefore strengthening European clinical research is an important goal of the European Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses. OJ L 82, 22.3.2001, p. 16-20 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV) 32001L0085. Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver's seat, and amending Directives 70/156/EEC and 97/27/EC Official Journal L 042 , 13/02/2002 P. 0001 - 0102 32001L0022. Commission Directive 2001/22/EC of 8 March 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs (Text with EEA relevance.) Official Journal L 077 , 16/03/2001 P. 0014 - 0021 Directive 2001/29/EC of the European Parliament and of the Council. (20) This Directive is based on principles and rules already laid down in the Directives currently in force in this area, in particular Directives 91/250/EEC(5), 92/100/EEC(6), 93/83/EEC(7), 93/98/EEC(8) and 96/9/EC(9), and Directives 2001/20/EC and 2005/28/EC and their implementing texts, to describe their impact, to specify problems encountered and to offer recommendations for the future. The clinical trials legislation is relatively recent. Directive 2001/20/EC of the European Parliament and of the Council established specific provisions regarding the conduct of The Directive 2001/20/EC however, from the two public consultations executed by the EC, one from October 9, 2009 to January 8, 2010 and the second from February 9, 2011 to May 13, 2011 , is not held in high regard by European stakeholders.

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