As we come out of summer and into autumn/fall, here at PleaseTech we are gearing up for the imminent release of PleaseReview v6.
This is a massive task as, for the first time in the product’s history (well technically the second time as PleaseReview was brand new back in 2005), we are not releasing an incremental enhancement or improvement, but a completely new review interface. It’s a bit like starting from scratch with a new product, with all the accompanying training and marketing documentation.
For those of you who’ve not attend the v6 preview webinars or followed some of the announcements, one significant addition to PleaseReview v6 will be redaction. We’ve added redaction in response to recent EU privacy and transparency regulations, specifically the EU EMA (European Medicines Agency) transparency policy 70 on the publication of clinical data. Whilst this is directed towards the Life Science industry, we also believe that redaction is universally useful especially in light of the various Freedom of Information directives and the need to redact PPI data from documents supplied under these directives.
Policy 70 has significant implications for Life Science companies in that they will need to redact and negotiate these redactions with the EMA on their European submissions. I am particularly grateful to Dr Patrick Cullinan of Takeda whose presentation on this subject I attended at the Annual Regulatory Writing for Product Approvals Conference held in April in Philadelphia.
Patrick has kindly permitted us to use some of his material in our forthcoming webinar series on ‘EMA transparency policies - the deepening challenge of redaction and review’ scheduled for September. The webinar will examine the background to the redaction requirement (i.e. policy 70) and demonstrate how the new PleaseReview v6 redaction capability can help organizations rise to the challenge. You can sign up here: http://www.pleasetech.com/webinars.aspx.
Redaction is a natural bedfellow of review and, when you think about it, it is simply another form of proposed change to a document - and so fits into the PleaseReview model extremely well. In practice, using PleaseReview, redactions can be ‘proposed’, they can then be discussed, the proposals can be accepted or rejected with reasons given and finally the proposed redactions are recorded in the reconciliation report so there is full traceability of decisions.
It is, of course, vitally important that these redacted documents are high quality and accurate (like all regulatory documents) and therefore they need to be reviewed extensively. In this respect, PleaseReview also supports the review of PDF documents with sections ‘Marked for Redaction’ using Adobe Acrobat Professional mark-up. This particular functionality is already part of PleaseReview and is a natural consequence of the way PleaseReview currently handles PDF documents. For more information on this please contact the support team.
Of course, PleaseReview v6 isn't all about redaction. As I mentioned at the very beginning we are introducing a completely new modern responsive interface at the same time. Watch this space for further information but, in the meantime, for more information on the forthcoming redaction capabilities, sign-up for the webinar.