CT Data Management • FDA/EMA Disclosure Requirements • Audit Preparation
- Philadelphia, Pennsylvania
Available for $495.00
Pharmaceutical and medical device companies are spending increasing resources to meet the requirements for clinical data disclosure. The EMA’s recent announcement that companies will soon be required to publish their clinical trials data starting January 1, 2014 has added another level of complexity to this discussion. As raw data must be made available to third party researchers and investigators, many professionals in this space have questions around public disclosure, data transparency, global competitiveness, patient confidentiality and more.
For the past seven years, industry stakeholders have collaboratively discussed the latest regulations for data disclosure and shared best practices for managing the ever-growing demands for clinical data registries and results. Join us this year to continue the conversation!
Topics of Discussion Include:
- Ensuring compliance with emerging FDA and EudraCT regulations
- Preparing for an FDA audit based on the information pulled from the registry
- Implementation of results reporting in the EU
- Submitting information across multiple registries
- Methods to fulfill legal requirements and protect intellectual property throughout the disclosure process
- New technologies for streamlining results posting