Wednesday, June 5th, 2019 - Frankfurt am Main
Official language: German
The legal basis for clinical research is changing rapidly and is driven in Europe and Germany by the EU legislation. On one hand there is the Clinical Trial Regulation EU 536/2014 and its national implementation which are delayed due to the EU Portal and database not yet up and running. On the other hand, there is the more recently General Data Protection Regulation EU 2016/679 (GDPR) and its national implementation (Datenschutz-Grundverordnung, DSGVO), come into force in May 2018, affecting patient rights and data processing. Both legislations are causing to some degree a level of uncertainty.
The German e-Pharma day will examine the consequences of the new regulations from different viewpoints: from patient rights to data protection in clinical research with a special focus on the national adaptations.
Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. The new ICH GCP Guidance Integrated Addendum (March 2018) provides a unified standard to facilitate the mutual acceptance of data from clinical trials.
During the conference the focus will be on:
Speakers from regulatory Authorities, Ethics Committees, pharmaceutical industry and associations as well as representatives from CROs will be involved. The e-pharma day always offers participants the opportunity to raising and discussion questions and solve doubts.
Martine Dehlinger-Kremer, Vice President Pediatric Development at Synteract, Heike Schön, Managing Director at LUMIS International and Herbert Eskötter, Medical Consultant, scientific board of the event, will lead a panel of experts to share best practices, knowledge and experience in this field.
Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers, Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the following departments:
• Clinical Research and Development
• Quality Assurance • Regulatory
• Clinical Operations
• Statistics and Data Management
• Information Technology
• Market Access
A portion of the proceeds from this event are donated to the “Vase of Flowers” project