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What this course offers<br />
• Training in meeting the requirements of the provisions of Article 57(2), second sub-paragraph of Regulation (EC) 726/2004 and the electronic submission of<br />
information on authorised medicinal products<br />
• Training in supporting the electronic submission of information on authorised medicinal products for Gateway users<br />
• Training in developing messages compliant with the published XEVPRM XSD schemas<br />
• Training in supporting the electronic submission of information on authorised medicinal products for Web trader and XEVMPD users<br />
• Hands-on training using the XEVMPD to generate XEVPRMs<br />
• Training in meeting the requirements of the provisions set out in the detailed guidance (“CT-3”) and the electronic submission of information on IMPs<br />
What this course does not cover<br />
• Training in developing and validating information or communication technology tools to produce messages compliant with the published XEVPRM and SSI XSD<br />
schemas<br />
• Training on all five ISO Identification of Medicinal Products (IDMP) standards and the Individual Case Safety Report (ICSR) standard as well as related ICH Implementation<br />
Guides<br />
• Training on IDMP, ICSR and Common Product Model (CPM) HL7 V3 messages<br />
Course Pre-requisites<br />
Participants are expected to have basic background knowledge of:<br />
• EU legislation and the revised guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the<br />
European Medicines Agency in accordance with Article 57 (2), second subparagraph of Regulation (EC) 726/2004<br />
• Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use<br />
(“CT-3”, cahpter 7.9, pragraph 104).<br />
To reach the widest possible audience, the XEVMPD training courses are offered face-to-face and through e-learning modules accessible online at the Agency’s website<br />
(e-learning modules will be released no later than mid April 2012).<br />
DIA Upcoming Training Courses in Safety and Pharmacovigilance<br />
� Benefit/Risk Management<br />
24-25 May 2012 | Munich, Germany | ID 12561<br />
� EMA Excellence in Pharmacovigilance: Clinical trials and post-marketing<br />
1-5 October 2012 | Prague, Czech Republic | ID 12566<br />
� EudraVigilance Information Day at the European Medicines Agency<br />
Date to be confirmed | London, United Kingdom | ID 12533<br />
21 September 2012 | London, United Kingdom | ID 12534<br />
� How to Prepare for Pharmacovigilance Audits and Inspections<br />
8-9 May 2012 | Berlin, Germany | ID 12556<br />
15-16 November 2012 | Prague, Czech Republic | ID 12575<br />
� IDMP Information Day at the European Medicines Agency<br />
8 May 2012 | London, United Kingdom | ID 12537<br />
4 December 2012 | London, United Kingdom | ID 12536<br />
� ICSR Information Day at the European Medicines Agency<br />
4 May 2012 | London, United Kingdom | ID 12535<br />
� Introduction to Pharmacovigilance and Electronic Transmission of Individual<br />
Case Safety Reports (ICSR) for the Use of Eudravigilance at the European Medicines<br />
Agency<br />
17 April 2012 | London, United Kingdom | ID 12538<br />
16 October 2012 | London, United Kingdom | ID 12539<br />
20 November 2012 | London, United Kingdom | ID 12540<br />
� Introduction to Signal Detection and Data Mining in Pharmacovigilance<br />
7-8 May 2012 | Berlin, Germany | ID 12555<br />
14-15 November 2012 | Prague, Czech Republic | ID 12574<br />
� Medical Approach in Diagnosis and Management of ADRs<br />
15–16 October 2012 | Paris, France | ID 12565<br />
� Practical Guide for Pharmacovigilance: Clinical trials and post-marketing<br />
21-23 May 2012 | Berlin, Germany | ID 12562<br />
� Pre-Marketing Clinical Safety<br />
26-27 April 2012 | Prague, Czech Republic | ID 12558<br />
� EudraVigilance (EV) - Electronic reporting of ICSR<br />
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)<br />
Courses throughout the year | European Medicines Agency, London, United Kingdom<br />
and selected European cities.<br />
For course details on EV, please visit www.diahome.org ><br />
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