B14 LBS…the options and the lessons

LBS….the options and lessons

The pathway to registration filing for Literature Based Submissions can be complex in preparation and coordination but, if done correctly, approval is possible.  Speakers will cover the following:

– Staged approach of steps to be undertaken

– LBS options and examples

– Regulatory experiences/issues/suggestions:

– overview of the differences in the new TGA LBS guidance,

– categorising evidence as pivotal/primary/secondary and

– addressing bias in the literature

– An overview of TGA experience, deficiencies, new guidance.

These are complicated submissions (not for the faint hearted) and this session aims to share experiences and educate attendees.

 

Chairperson: Theresa Dickson-Bogie, Biotech Regulatory Solutions