Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Assessment of Multinational Clinical Trial Aplication within the European Union: Experience and Expectation of the Voluntary Harmonization Procedure ***

Dr. Mareille Warnken-Uhlich (Abschlußjahr: 2015)

Summary
Language: English
Implementation of the Clinical Trials Directive 2001/20/EC into national law of all European Member States has clearly improved the level of harmonization of the conduct of clinical trial applications and approval process. But apparently not all the objectives of the Directive with regard to the harmonization of procedures and reducing administrative burdens in the preparation and performing of clinical trials have been achieved. Differences in interpretation of the processes harmonised by the CTD, resulted in even higher complexity levels - especially in the performance of multi-national clinical trials.
To address some of the key issues raising by different stakeholders in 2009 the Clinical Trial Facilitation Group has introduce the Voluntary Harmonisation Procedure (VHP). Within the current legal framework the VHP provide the opportunity and the basic conditions for a coordinated or shared scientific assessment of multinational clinical trials with the aim to set up best practices between Member States. This leads to improved interactions between the National Competent Authorities and to harmonised processes and practices to avoid divergent decisions.
Thus, the VHP has successfully provided a process through which some of the concerns of the Clinical Trials Directive have been addressed without introducing a new legislation. However, it has not addressed many other issues linked to the interpretation of the Clinical Trials Directive, particularly those where clinical trial application approval is linked to Ethics Committee review. Therefore, there is still a requirement to enhance the regulatory environment to make the European region a more attractive place to conduct clinical trials. To achieve this objective and to offer a modern regulatory framework the new Clinical Trail Regulation EU No 536/2014 has been developed. Similar to the VHP, the Regulation will introduce a streamlined, electronically submission procedure for all clinical trial applications, both single and multinational trials.
This Master Thesis brings into focus the development and usefulness of the VHP - first originally introduced to address raising concerns with the Clinical Trials Directive and to present flexible solutions; and second extremely valuable to provide experiences for planning and implementation of the clinical trial application procedure of the new European Clinical Trial Regulation.
Pages: 47; Annexes: 4; Pages: 7