Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implications of the Revised EMA Clinical Trials Transparency Policy on Industry and Public Healthcare

Dr. Peter Schneider (Abschlußjahr: 2015)

Summary
Language: English
Transparency is a fundamental value embossed in the Treaty on European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU) that further translates into Regulation (EC) 1049/2001. The European Medicines Agency EMA accounts for it in its policy 0043 and has recently adopted a pro-active publication approach for clinical trials via its policy 0070. The policy is viewed as highly controversial and must accommodate conflicting interests of various stakeholders ranging from pharmaceutical industry to patients and public health. Hence, the EMA's policy constitutes a compromise that allows for the redaction of commercially confidential information and personal data of clinical trial subjects and personnel involved in the studies. This thesis elaborates on the pros and cons of transparency, the risks associated with it and the impact of transparency on clinical trials for the various stakeholders.
Pages: 38, Annex: pages : 2