19 Sep Big data or big deal?
This quarter marks the breakthrough of data-integrity as a new, important element of GMP-systems worldwide. While the MHRA already issued its Guidance for Industry in March 2015, in April 2016 the FDA issued a similar guideline. So we will have to prepare ourselves for this theme to arrive on the table during GMP-audits. For that reason, we will have to perform internal data-integrity audits with our clients as of now. The first of such internal audits is planned for July 2016.
Data is also what marketing authorisation applications are about and in June 2016 we managed to finalise two Decentralised Procedures, which we executed on behalf of a generic company. One of these was rather uncomplicated but for the other one we had to attend an EMA-meeting in London (CMDh) to discuss serious issues about the synthesis data of the active ingredient. However, the assessors from the reference member state (The Netherlands) took a constructive and sympathetic position, thanks to which we were able to come to a positive conclusion at Day 210.
Talking about data and the EMA, it is now rumoured that doubts have emerged in the EMA offices in London about what to do with the massive amount of pharmacovigilance data they are currently receiving from drug companies regarding the numerous medicinal products circulating within the European pharmaceutical market. Does it really deliver “value for money” asking these pharmaceutical companies to put so much money and effort in collecting these data? Not to mention the numerous inspectors in the various member states performing vigilance audits within such companies, as they did within our premises last week. Only time will tell if this “big data project” will deliver or fail, but regardless of the outcome we will have learned quite a lot from it. If it were only to prevent the medical devices industry from entering the same dead-end street in case it indeed appears a “big deal”.
Originally published 26th July, 2016, by Baggerman Pharma Consult BV, The Netherlands at http://bfc.nl/news/q22016-big-data-or-big-deal/