Webinar on Article 57 EudraVigilance Medicinal Product Dictionary - implementation challenges

A complimentary webinar on Article 57, EudraVigilance medicinal product dictionary (EVMPD): the mandatory European pharmacovigilance reporting requirements. Please register here.

Date: 4 April 2012

Time:

09.00-10.00 EST
14.00-15.00 GMT
15.00-16.00 GMT+1

Speakers

• Deborah Cooper, Senior Life Sciences Consultant at PA Consulting Group and former Regional IT Director for Johnson & Johnson Consumer Health Care. Deborah implemented the E2B Electronic reporting of ICSRs through the Cyclone gateway for the Johnson & Johnson Group of companies and defined the original business case that secured funding for an in-house Medicinal Product Dictionary. Selected as DIA trainer on EVMPD and electronic reporting of adverse events (E2B), she has guided both regulators and industry.

• David Lerner, Senior Life Sciences Consultant at PA Consulting Group specialises in transforming business operations within quality, regulatory and manufacturing operations in the life science industry. For the last five years, David has assisted his clients in developing and implementing global regulatory change management processes and systems including the collection and maintenance of product, regulatory and CMC data. David manages large, complex and global programmes.

• Simon Hall, Senior Life Sciences consultant at PA Consulting Group is an IT and Connected Healthcare specialist. Simon has architected and managed delivery of IT implementations in healthcare provider, pharmaceutical and finance sectors. He specialises in IT solution design and leads much of PA’s healthcare solution work; he also has a background in managing quality assurance in multi-supplier environments and has managed QA assurance of the integration of two retail banks.

Why attend?

This is the second Webinar addressing Article 57 regulation and challenges. During this informal discussion, we will share our current insights and provide recommendations following the recent update to the mandatory European reporting requirements. Topics will include:

• Results of Article 57 poll

• Data collection challenges

• Approaches for tackling translation

• Pre-requisites for MedDRA coding

• Data maintenance options

• Input mechanisms

• Short-term & long-term objectives

• Article 57 Cloud.

Please register here.

Date: 4 April 2012

Time:

09.00-10.00 EST
14.00-15.00 GMT
15.00-16.00 GMT+1

If you have any queries about the webinar, please contact Stefan Lysak by email.

To find out how PA can help your organisation develop successful strategies for the pharmacovigilance reporting requirements, please contact us now.