Webcast Replay: 2013

IDMP Standards Update - One Year after Publication

The ISO published Identification of Medicinal Products (IDMP) standards almost a year ago (November 2012). EMA’s Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) have also been in currency for almost 1.5 years i.e. since July 02, 2012. However, the compliance efforts for XEVMPD and readiness for IDMP still leaves lot to...Read More »

Done with EVMPD... looking forward to IDMP

By now pharmaceutical industry is quite familiar and compliant with EVMPD. The next step, IDMP standards have been published by the ISO in November 2012. The next big challenge is to ensure that while maintaining full EVMPD compliance, companies need to prepare their systems and gather required data to ensure...Read More »

2013 Regulatory Review and Outlook for 2014

Wim Cypers, Vice President, Regulatory Affairs will review the eventful year of 2013 as it comes to close for Regulatory Affairs professionals. He will assess the situation as it stands for xEVMPD initiative of the EMA, the IDMP initiatives at FDA, EMA and other regulatory authorities as well as the...Read More »

Taking Compliance to the Cloud

The global regulatory landscape is changing fast. Authorities are mandating that most of compliance submissions be made electronically. The xEVMPD standard of 2011 or the upcoming E2B (R3) and IDMP (IDentification of Medicinal Products) standards are examples of these changes. Staying ahead of technology curve could be a game changer...Read More »