The programme will feature areas of major relevance for today’s and tomorrow’s Good Clinical Practice (GCP):
New EU Clinical Trials Legislation – Any Impact on the Balance between the Powers?
• Discussion of the GCP-relevant aspects in the Commission’s new legislative proposal
• Analysis of eventual changes in the roles and responsibilities of the relevant players
• Any impact on GCP of a single portal and single approval?
New Quality Paradigms for Safe and Efficient Clinical Drug Research
• The potential value of applying standards from other industries to re-define GCP: the ACRES concept
• Risk adapted monitoring approaches including EDC and monitoring technology options
• Risk adapted quality assurance: foreseeable effects on SOP-systems, audits and inspections?
The Emerging Role of Transparency for Current GCP
• Data privacy and data protection in clinical trials – priorities and pitfalls for patients and investigators
• Negotiating data ownership and publication rights: central elements to define sponsorship
• Data sharing and open access to trial data. Any recommendations and standards in view?