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 pharmacovigilancedatabase has achieved full functionality was made in May 2017.
This is of major importance for marketing authorisation 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.
Quanticate and Pharmasol are pleased to partner for this webinar addressing a major step forward in the pharmaceutical industry from both a technical perspective as well as the day-to-day case management impact onpharmacovigilance departments. 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.
This webinar will address:
- 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
Tom Nichols, Senior Director, Pharmacovigilance, Quanticate
Tom has over 8 years of experience in Pharmacovigilance including clinical phases I-IV as well as post-marketing. He is proficient in Argus and ARISg database administration and is qualified to use EVWeb and XEVMPD. Tom’s project experience includes; regional lead on global database migration and consolidation, new GvP and Clinical Trial Regulation readiness and implementation groups, EMA Stakeholder Subgroup H ‘Safety Reporting’ member, as well as ensuring audit/ Inspection readiness and CAPA delivery. He is a member of PIPA Committee Member and lead of the PV Regulations and Guidelines work stream. After a number of years working in the generics sector, Tom was most recently overseeing safety in high-risk, early phase oncology trials, including many First-in-Class or First-in-Man.
Dr. Marc Zittartz, Chief Quality Officer, pharmasol
Dr. Marc Zittartz joined pharmasol in 2013 as Chief Quality Officer and member of the executive management team to develop and implement pharmasol’s strategy to deliver innovative software solutions, GxP compliant cloud hosting and expert consulting service for the life science industry. Dr. Zittartz has more than 10 years of experience in the life science industry in both Europe and USA. In his previous roles he successfully managed all aspects of GxP relevant IT applications in the areas of Regulatory Affairs, Clinical Development, and Pharmacovigilance. Dr. Zittartz holds a PhD. in physics from the University of Cologne, Germany. Throughout his career he has been a consistent contributor to the advancement of R&D IT solutions through several networks such as DIA.
Who Should Attend?
Senior pharmacovigilance professionals working at any stage of the product life-cycle , including those involved with case processing, compliance or database management and case reporting
Quanticate, headquartered in the UK and USA, is a leading global Clinical Research Organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As The Clinical Data Experts our team provides high quality, efficient outsourcing solutions for companies who need additional capacity or who want to outsource certain activities in their entirety.
Our clinical and post-marketing services include scalable on-site and off-site clinical data management, biostatistics, clinical programming, PK/PD analysis, medical writing, pharmacovigilance and consultancy. Quanticate was announced a five category winner in the annual CRO Leadership Awards for Quality, Reliability, Productivity, Regulatory and Innovation. Quanticate was the first CRO to introduce the Centralized Service Provision (CSP) approach to outsourcing supported by its data centralization and visualization tool for both single study and cross-study data analysis. Please visit the website at www.quanticate.com for further information and access to white papers.