The regulation of companion IVDs in Australia differs from the regulation of these products internationally, e.g. EU – In Vitro Diagnostic Directive (IVDD); US – Federal FD&C Act and relevant medical device regulations etc. This session aims to look at companion diagnostics from a global perspective including both the regulatory and reimbursement implications and complexities.
Chairperson: Alexandra Mactavish, Merck Serono
- Regulatory Affairs
- Date:May 7, 2015
- Time:4:00 pm