With the recent confirmation that the EudraVigilance database has achieved full functionality, and the associated introduction of E2B(R3) format, it is important Marketing Authorisation Holders are aware of the challenges to be faced. Quanticate and Pharmasol are pleased to partner for this webinar addressing a major step forward in the industry from both a technical perspective as well as the day-to-day impact on pharmacovigilance departments. Key aspects will be covered such as the gaps needed to be addressed before 22nd November, and whether a hosted approach to your safety databases proves the most effective strategy for ensuring compliance.
Duration: 60 minutes
Speakers :Tom Nichols, Senior Director, Pharmacovigilance, Quanticate & Dr. Marc Zittartz, Chief Quality Officer, Pharmasol
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