Harnessing successful case-study driven presentations and a multitude of interactive discussion-led formats, World CDx Regulation 2016 offered a granular investigation into what the regulatory agencies are looking for and lessons learnt from past approvals.
Attendees learnt how to develop an robust regulatory approval strategy as they received channel industry-defining knowledge and game-changing ideas on how to:
- Best navigate the major global regulatory landscapes for companion diagnostics to accelerate speed to market
- Harness the fallout from recent updates on the regulatory guidance for laboratory-developed tests and the impact this will have on the diagnostic field as a whole
- Successfully align drug-companion diagnostic co-development for increased regulatory compliance and synergy to enhance cooperation between stakeholders
- Understand the current state of play with regulation of next generation sequencing platforms and the impact this will have on companion diagnostics and “companion therapeutics”
- Navigate the key evolving global regulatory landscapes of the EU, China, and Japan to achieve worldwide acceleration to market.