Transcription of CT authorisation in the EU: present and future
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CT authorisation in the EU: present and future
CT authorisation in the EU: present and future Karl Broich, BfArM. Karl Broich | CT authorisation in the EU: present and future | 09 March 2018 | Page 1. Contents Clinical Trials in the EU. Clinical Trials under Regulation (EU) No. 536/2014. Transition period from Directive to Regulation Clinical Trials Portal & Database programme Current & future challenges for the NCAs Conclusions Karl Broich | CT authorisation in the EU: present and future | 09 March 2018 | Page 2. Clinical Trials in Europe: What is new? Clinical Trials in the EU what has changed over time? Before May 2004 Directive 2001/20/EC Regulation (EU) No. 536/2014. (since 1 May 2004) (published May 2014). National rules, different First step to harmonise processes Full harmonisation and combined processes/requirements for and requirements for clinical trial assessment of multinational trials authorisations (after full functionality of the EU.)
implementation in national laws room for national specialities (timelines etc.) • Lack of harmonisation between Member ... Stepwise software development and testing (UATs) acc. to specifications ; Independent audit reviews functionality and compliance with specifications
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