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Andrew Marr

Andrew Marr

Leading consultant on XEVMPD and IDMP, consulting with many pharmaceutical, services and software companies. Active member of the ISO committee that developed the ISO IDMP standards. Former member of ICH M2, heavily involved in the development of the current eCTD specification and M2 Rapporteur, leading the group during the development of the requirements for the new version of the eCTD.

 

Recent Posts


IDMP: A Big Data Challenge for European Pharma

Written by Andrew Marr in Life Sciences on 23/05/17


At this year’s AMPLEXOR “Be The Expert 2017” event, Pharm Exec spoke to Andrew Marr about the implications of the EU’s new IDMP (Identification of Medicinal Products) regulations for the pharmaceutical industry.

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EMA issues revised guidance on XEVMPD

Written by Andrew Marr in Life Sciences on 07/12/15


Just before Christmas (on 22 December to be precise) EMA finally issued a revised Chapter 3.II: XEVPRM User Guidance. This was pretty late timing, since all resubmissions were supposed to be made by 31 December. It is highly unlikely that companies will be able to respond to this guidance immediately, but it may be of relevance for maintenance submissions, or in explaining how EMA may change the data submitted when they QC review the XEVPRMs submitted.

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