Challenges and opportunities in transition from XEVMPD to ISO IDMP
Implementation of XEVMPD has been very challenging for everyone involved – regulators, industry, software vendors, and service providers, especially because of short timeframes, deadlines and changes in the technical requirements. Learning from that experience may help to avoid problems before ISO IDMP becomes mandatory.
During the webinar you will learn about the key differences between XEVMPD and ISO IDMP, additional data that needs to be collected such as substance information, manufacturing and packaging details, clinical particulars etc.; identify the challenges of transition to the new standard and potential differences between implementations in USA, EU and other regulatory regions.
We will also show how a software tool can help overcome these challenges, and which main points should be taken in consideration when evaluating a solution for ISO IDMP.
After the webinar you should have a much better understanding of the new standard, allowing you to better prepare for the upcoming requirements.
Presented by
Andrew Marr,
Managing Director
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 joint chair of the ICH M2/M5 Expert Working Group involved in the development and implementation of IDMP. Author of several journal articles on XEVMPD.
Sinisa Belina,
Senior Life Sciences Consultant
Mr. Belina started his professional career in TEVA Group. In addition to his responsibilities in manufacturing, he was part of the successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs department and finally moved to INFOTEHNA. He applies his detailed knowledge of pharmaceutical documentation and processes to areas of business process analysis and optimization of EDMS.
