Regulatory Collaboration Through Cloud Platforms

Description: This session will explore how cloud-based IT platforms are being utilized as collaboration tools for applicants and health authorities. During this session, an industry representative will provide a US and Europe regulatory landscape assessment of cloud-based IT platforms, including related PDUFA VII commitments, projects, initiatives, and opportunities. The panel will also include three speakers that will describe ongoing cloud-based initiatives and activities:

• DEEP – Digital Evidence Ecosystem and Protocols. DEEP enables pre-competitive collaborations to define measurement standards and scales regulatory acceptance of novel digital endpoints across the ecosystem
• Accumulus Synergy – Working to enable a new way for regulatory agencies to interact across the globe, and with life science stakeholders, that will dramatically accelerate critical therapies to citizens of the world.
• ICMRA – ICMRA is looking into ways to work more efficiently and utilize cloud-based IT platforms for collaborative working. One such example includes, establishing a pharmaceutical quality knowledge management system. ICMRA will describe this initiative, as well as other ways they are thinking about cloud-based IT platforms for collaborative working.
Short presentations by each speaker with key messages on expectations will be followed by a moderated panel discussion where opportunities and challenges will be explored.
The session will end with a summary of findings and next steps to continue this cross-stakeholder dialog towards how to better and more efficiently collaborate through the use of cloud-based IT platforms.