Founder & Chief Executive Officer
11:20 Creating a Masterfile of all the data needed to apply for licence: How realistic is the concept of standardisation?
- How far are we from this? What areas would we standardise?
- What can we do if we bring our strengths together?
- Harmonising standards between Europe and overseas to ease trade between different countries
- Creating a master file – is that possible? What are the plans?
- Creating a database of studies already done in the space, so people don’t need to do studies again
- Testing methodology and properties that are common and that can be used to apply for PMTA.What should these look like for everyone?
- Standards for toxicity – how to access toxicity?
- Can we change the rules if we get together?
- Filing Litigations: The process and the outcome
- Examining potential risk and costs associate with filing litigations against regulatory bodies