Overview
Disclosure and transparency of clinical trial information is taking on new dimensions, resulting in trial sponsors and research organisations facing a host of new requirements in the EU, US, and other places in the world. This 2018 Conference builds on prior conference discussions and leverages learnings from International experts, providing the opportunity to gain insights on how to meet the new challenges and opportunities. The program is assembled around key themes:
- Upcoming implementation of the EU Clinical Trial Regulation: Portal and Database Status/Updates
- Operational tools and strategies sponsors are using to comply with EMAs Clinical Data Publication Policy 0070
- Best practices in meeting the expanded requirements of the NIH Final Rule for FDAAA (42 CFR Part 11)
- Legal requirements related to disclosure of clinical research information for medicinal products and medical devices
- How the new ICMJE data sharing requirements are being implemented
- Impact of the EU General Data Protection Regulation (GDPR) on data sharing
- Approaches to navigating and complying with global disclosure and transparency requirements
Targeted Audience
- Professionals and experts from areas affected by public disclosure across drug and medical device development (regulatory
affairs, scientific affairs, medical writing, clinical operations, medical communication, biostatisticians/biometrics, project
management, medical affairs, legal, patent departments, etc.) - Consultants, CROs and companies that offer services for clinical registries, publication planning and medical writing
- Patient organisations
- Regulatory agencies
- Academic institutions
Exhibiting Opportunities
At this years’ Clinical Trial Disclosure and Data Transparency Conference, we are offering Two Exhibiting Options: A Tabletop Display for EUR 3000.00 or a Booth Space 3m x 2m.
Exhibitor Prospectus
Please download our prospectus for an exhibitor application form and further information on available exhibiting, advertising and hosting opportunities.
If you would like further information please email DIAexhibition@kit-group.org
Interested in also exhibiting at the DIA Clinical Trial Conference on the 17th - 18th September, also at the Hilton Docklands Riverside, London? Contact DIAexhibition@kit-group.org to enquiry about a discount for exhibiting at both events.
Exhibiting Companies
- GCE Solutions Inc
- Kinapse Ltd.
- PA Consulting
- Privacy Analytics
- Trial Scope
- TrialAssure
- Xogene Services
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