Around the CDx World in 80 Days: Navigating Companion Diagnostics Challenges from US to Japan to China to EU
- Presenting recent case-studies on CDx filings/approvals in US, Japan, China and EU territories from the Pharma perspective
- Highlighting issues to anticipate and challenges to expect and learn to expect the unexpected
- Working with accelerated approvals timelines
- The importance of ‘Local’ knowledge
- Terra incognita … IVD filings beyond the Big 4