SOURCE: Xtalks

Xtalks Webinars

October 06, 2017 07:00 ET

Pharmacovigilance Database E2B(R3) Compliance: A Technical and Practical Perspective

TORONTO, ON--(Marketwired - October 06, 2017) - In a complimentary webinar taking place on Thursday, October 26, 2016 at 11am EDT (4pm BST) industry experts Tom Nichols, Senior Director of Pharmacovigilance at Quanticate and Dr. Marc Zittartz, Chief Quality Officer at Pharmasol will address a major step forward in the pharmaceutical industry from both a technical perspective as well as the day-to-day case management impact on pharmacovigilance departments.

More than 10 years ago, electronic reporting of adverse event information to regulatory authorities was introduced in Europe. The E2B(R2) specification allowed for the information to be exchanged in a standardized and cost-effective way. Due to the evolving requirements of regulatory authorities and the goal for a truly global standard, the E2B(R3) specification was developed, and the associated recent confirmation that the EudraVigilance pharmacovigilance database has achieved full functionality was made in May 2017.

This is of major importance for marketing authorization holders and sponsors alike, who should be aware of the pharmacovigilance challenges to be faced. At first sight, this may seem to be a technical topic however it has a deep impact on day-to-day pharmacovigilance operations. E2B(R3) is currently being incorporated into the Good Pharmacovigilance Practice Module VI: Management and reporting of adverse reactions to medicinal products.

This webinar is suitable for both those looking for an introduction to the updated pharmacovigilance standards and those looking to ensure they can implement the necessary changes within their department or team.

The session will discuss:

  • What gaps need to be addressed before November 22, 2017
  • Whether a hosted approach to the safety database is the most effective strategy for ensuring compliance
  • How to avoid the use of interim transition tools or costly internal upgrades

To learn more about this event visit: Pharmacovigilance Database E2B(R3) Compliance: A Technical and Practical Perspective


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