Pharmacovigilance

Full and ad hoc PV services including:

  • Qualified Person responsible for Pharmacovigilance (QPPV) / Deputy QPPV services with 24-hour cover
  • Safety Physician Services
  • Safety Data Exchange Agreements (SDEAs)
  • Risk Management Plans (RMPs)
  • Creation and Maintenance of Pharmacovigilance Safety Master Files (PSMFs)
  • Periodic Safety Update Reports (PSURs)
  • Signal Detection and Management – including the use of EVDAS (EudraVigilance Data Analysis System)

  • Electronic PSUR Portal Registration & Submissions
  • Individual Case Safety Report (ICSR) Processing
  • Fully validated Pharmacovigilance Safety Database
  • Expedited Reporting to Authorities
  • EudraVigilance Set-up, Maintenance and registration
  • XEVMPD Maintenance
  • Company specific Standard Operating Procedure (SOP) Creation and Review
  • Weekly Literature Monitoring

Regulatory Affairs

Pre-authorisation

 

  • Marketing authorisation applications and submissions
  • Product information
    • Creation of SmPCs, PILs and labelling
    • Creation of mock-ups
    • Braille verification
    • Readability user testing
  • Creation of Risk Management Plans
  • Quality Overall Summaries
  • Clinical and Non-clinical Overviews

Post-authorisation maintenance

 

  • Variations
  • Marketing authorisation renewals
  • Marketing authorisation extensions
  • Sunset clause submissions
  • Marketing authorisation transfers
  • Marketing authorisation withdrawals
  • Creation and submission of PSURs
  • Maintenance of product information
  • Extended Eudravigilance Product Report Message
    (XEVMPD) maintenance

Veterinary Pharmacovigilance

Full and ad hoc PV services including:

  • A Qualified Person responsible for Pharmacovigilance (QPPV) / Deputy QPPV services with 24-hour cover
  • Veterinarian Services
  • Safety Data Exchange Agreements (SDEAs)
  • Risk Management System review and input
  • Creation and Maintenance of Detailed Description of Pharmacovigilance System (DDPS)
  • Periodic Safety Update Report (PSURs)
  • Signal Detection and Management

  • Adverse event processing and reporting
  • Fully validated PV Safety Database
  • Expedited Reporting to Authorities
  • EudraVigilance Set-up, Maintenance & registration
  • EudraVigilance Veterinary Medicinal Product Dictionary (EVVetMPD) maintenance
  • Company specific SOP Creation & Review
  • Weekly Literature Monitoring

Clinical Trials Services

  • Panacea holds an established approach to supporting companies, helping to effectively contribute new and improved products to the market in the most efficient manner, and with as little resources as allowable. Through offering their range of Clinical Trials Services, Panacea ensure all streamlined clinical trials meet the regulatory and ethical requirements.

  • The range of Clinical Trials Services offered include:
    • Review of clinical trial pharmacovigilance SOPs
    • Review of the pharmacovigilance aspects of the protocol and Investigator’s Brochure (IB)
    • Set up of agreements for safety data exchange
    • SAE and SUSAR processing
    • Expedited reporting of SUSARs to Regulatory Authorities and ethics committees
    • SAE reconciliation
    • DSUR/annual safety report preparation or input

Compliance & Training Services

  • Our experienced team provides auditing services which can be invaluable for clients preparing for an Authority inspection. We offer our own rigorous pre-inspection programme to make sure that all relevant procedures are in place, and in compliance with current legislation. Clients value Panacea’s thorough approach which ensures that any issues are addressed prior to the Authority inspection. Panacea can also conduct routine audits as part of your external audit schedule.
    • Pharmacovigilance Auditing & Audit Readiness
    • Inspection Readiness
    • Quality Systems Reviews

  • We have a wealth of experience in creating and delivering cost-effective training courses which are specifically tailored to suit our clients’ needs. These range from introductory to advanced level courses on a range of subjects, including:
    • Pharmacovigilance
    • Device Vigilance
    • Regulatory Affairs