IDMP Blog : EMA is not ready to share their roadmap for IDMP

Read the blog on the Infotehna website

http://www.infotehna.com/blog/items/ema-is-not-ready-to-share-their-roadmap-for-idmp

 

DIA have published the programme for the DIA Electronic Document Management Meeting: Berlin 1-3 December 2014

DIA have just published the first version of the programme for their Electronic Document Management Meeting to be held in Berlin on 1-3 December 2014.  The programme can be downloaded from here.

Andrew Marr will be chairing two sessions at the conference, one on Preparing for Implementation of IDMP and the other on Business Models for Getting the Regulatory Work Done.

In addition, there will be a pre-conference workshop on IDMP being run by Frits Stulp of Mesa Arch Consulting.

Andrew Marr will be running a workshop on XEVMPD/IDMP for TOPRA on 2 October 2014

Andrew Marr will be running a workshop on XEVMPD and IDMP for the TOPRA ERA SPIN at the TOPRA offices in London on 2 October 2014.  Details of the meeting can be found on the TOPRA website.  The meeting is free but you need to be a TOPRA member.

IDMP Blog: Commitment from Regulators sets IDMP on a progressive path

Read my bog on ProductLife’s website

 

Andrew Marr to speak at ProductLife’s Webinar on Preparing for IDMP on 18 September 2014

Andrew Marr will be presenting on the status of IDMP and how to prepare for its implementation in Europe from July 2016.  The session will be hosted by ProductLife on 18 September 2014.  Details of how to register can be found at:

Link to Webinar details:

IDMP Blog: The Value of RIM for IDMP: Informal Survey Reveals a Broad Range of Approaches

Read my blog on ProductLife’s website.

Andrew Marr assesses further the revised XEVMPD guidance from EMA

Andrew Marr assesses further the impact of the revised guidance on XEVMPD issued by EMA on 31 January 2014, together with subsequent revisions and additions.  The article looks at how companies should be responding to this guidance, how they should update their information and then prepare to maintain it..

A major exercise to update date to meet new requirements will be needed by MAHs.  Re-submission of all Authorised Medicinal Product and Organisation records will be required between 16 June and 31 December 2014 and then maintained within 30 calendar days of any change.

Click here to view the journal article. Journal Article

This article was published in the June 2014 edition of Regulatory Rapporteur.

Call for Abstracts – DIA European EDM Meeting – Berlin – December 2&3 2014

There is a Call for Abstracts for the European Electronic Document Management  Meeting to be held in Berlin on 2&3 December 2014.  More details about the meeting and how to submit abstracts can be found here.

Andrew Marr is a member of the Programme Committee.

XEVMPD Blog: EMA Sets the Stage for Release of Substance Vocabularies and Schemas

Read my blog on ProductLife’s website

XEVMPD Blog : Clearing the Air: EMA’s Revisions and FAQs Seek to Provide XEVMPD Clarity

Read my blog on ProductLife’s website.