Returning from a conference is always a whirlwind & DIA Amsterdam 2019 was no exception. I represented d-wise sharing the message that we're able to help sponsors with their transparency needs. Our software and service offerings can meet them at whatever stage they're at & get them where they need to be.
There were seven sessions throughout the 3-day conference but one theme was central- harmonisation between different agencies.
With the fear of receiving a Health Canada request, the tight timelines that accompany it, and the approaching restart of EMA policy 0070 many of the agencies bonded together to forage a strategy for the upcoming year.
Health Canada and the EMA have given indication that they are currently having negotiations with the aim of harmonising some aspects of data sharing but there has been no public sharing of any aspects that have been agreed so far. Largely, the two policies are aligned although there are some stark distinctions between them.
Health Canada revealed that they have only a team of 3 reviewers, supported with 3 administrative staff dealing with PRCI. Despite this, they are still managing to maintain timelines close to their 120 day limit. Sponsors speaking from experiences with Health Canada PRCI have emphasised how useful the teleconference conversations have been with Health Canada. Some flexibility in special cases have also been discussed.
