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XEVMPD: LONG-TERM EXPECTATIONS AND BENEFITS
Session Chair(s)
Karl-Heinz Loebel
Director, Principle Consultant Regulatory Operations
PharmaLex GmbH, Germany
In the last two years enormous resources have been spent on data collection to feed EMA’s EVMPD database with the requested information on authorised medicinal products. After a comparatively slow start, especially since October 2011, industry had to make tremendous efforts to gather detailed knowledge on the requirements, develop or acquire software solutions, and train staff. On the other hand, the EMA had to deal with the administrative, organisational and technical challenge and with the estimated several hundred thousand datasets submitted by, presumably, thousands of Marketing Authorisation Holders. This session will analyse the experiences gained so far and project the future use of EMA’s EVMPD database from the Agency's and industry’s perspective. It will focus on the resources spent on data collection, critically discuss benefits and risks for industries of different sizes and market orientation and give an outlook on the future development of the database, the transmission standards and their consequences for Marketing Authorisation Holders.
Speaker(s)
Electronic Submission of Information on Medicines in the Context of the New Pharmacovigilance Legislation in the EU: Current status and next steps
Sebastian Knieps
Lionpharm Regulatory Consulting GmbH, Germany
Managing Director
XEVMPD and IDMP: Current Challenges and Future Chances, Lessons learned from industry perspective, Impact of XEVMPD and IDMP on RIMS: A holistic approach, IDMP standards as a chance for effective and efficient regulatory data management
Timm Pauli
PharmaLex , United States
Head of Regulatory Operations
EVMPD/XEVPRM from SMEs’ perspectives, EVWEB – challenges, limitations and opportunities, overall long-term effects and expectations
Karl-Heinz Loebel
PharmaLex GmbH, Germany
Director, Principle Consultant Regulatory Operations
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