PhV Day 2018 Pharmacovigilance

seQure welcomes Pharmacovigilance Day in its home city. Also this year we have confirmed our presence at Pharmacovigilance Day (PhV Day)

We will attend the Italian edition that will take place in Rome on the 7th of November. PhV Day brings together experts from pharma and medical devices companies, biotech, regulatory authorities, and academic research centers with one goal – discuss the hottest topics in pharmacovigilance. This year the agenda revolves around the following arguments:

This year the agenda revolves around the following arguments:

  • Brexit;
  • New legislation like EU General Data Protection Regulation and Regulation No 536/2014 on clinical trials on medicinal products for human use;
  • Quality systems and patient security;
  • European Medicines Agency relocation and its impact on the regulatory landscape;
  • Relocation of EUQPPV and PSMF and its impact on the industry;
  • Product quality and data integrity;

Our Vice President and Scientific Director Daniela Marcozzi is not only present at PhV Day and available for personal meetings but also guides the Expert Panel that includes prominent professionals from regulatory bodies, pharmaceutical companies and service provider companies. Make sure you join the discussion!

Quality Assurance in Pharmacovigilance

This year we have a particular focus on Quality Assurance in Pharmacovigilance and will showcase our expert QA services specifically for pharmacovigilance and GVP requirements.

seQure’s team has particular expertise in quality and compliance solutions for Pharmacovigilance Systems ensuring PV processes and systems are compliant and our client’s company is ready for PV Audits and Inspections.

Are you interested in one of these areas listed below? Then make sure you schedule a meeting with us at PhV Day!

  • Preparation of Quality Manual, Policy, SOPs and Work Instructions;
  • Development of process mapping for PV systems;
  • Development & Management of KPIs;
  • PV Audit planning, conduct, and reporting;
  • Development of CAPA (Corrective and Preventive Action);
  • Support for identifying advanced compliance solutions;
  • PV and Quality Compliance consultancy;
  • Support for PV Inspection preparation.

Do not have any particular need? Just stop by to say hello and chat!

Won’t be able to attend PhV Day in Rome, but still want to meet? Drop us a message through the contact form and we will arrange an additional appointment.

 

 

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