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EMA and Brexit Yet Again: Part 2

As I noted in my last post, the Brexit and EMA saga continues.

From the EMA  Perspective

There are two important documents to briefly look at to get an idea of where the EMA is going.

EMA Final Programming Document

The first is the “Final Programming Document 2018-2020 issued by the EMA in December 2017. It is 153 pages long. We will do a brief review of the information relevant to PV and Drug Safety.

First there is a review of the mission and goals. Next a discussion of challenges and risks which runs a dozen pages. The key challenges are:

There are several work flows and they may be examined in the document. In each flow there are three sets of priorities: 1) highest priority-covering core scientific activities including protection of the safety of patients, inspections and IT 2) medium priority and 3) lowest.

The choices for each activity are 1) continue business as usual 2) temporary reduction either of volume or time but maintain high standards and 3) suspension of activities.

The following cutbacks may touch DS and PV:

Next the ongoing projects covering the EMA are listed, along with the performance indicators and the start stop dates for projects due to end in 2019 or 2020.  Some projects will be affected, including:

In early August the EMA issued an update indicating that phase 3 will be put in place no later than October 1, 2018 and that the peak relocation activities will start in early 2019 (giving them under 3 months to relocate).  Further details on these activities will be released shortly.

Other EMA News

From the UK MHRA Perspective

Now through March 31, 2019

During the Implementation Period (March 31, 2019 – December 2020)

In my next post, I’ll go into more depth about the lack of a Brexit agreement between the UK and the EU.

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