Pharmacovigilance

  • A Qualified Person responsible for
    Pharmacovigilance (QPPV) / Deputy QPPV services
    (24 hour cover)
  • Safety Physician Services
  • Full and ad hoc PV services including:
    • Safety Data Exchange Agreements (SDEAs)
    • Risk Management Plans (RMPs)
    • Creation and Maintenance of Pharmacovigilance
      Safety Master Files (PSMFs)
    • Periodic Safety Update Report (PSUR’s)
    • Electronic PSUR Portal Registration & Submissions
      Signal Detection and Management

  • 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 SmPC’s , PIL’s and labelling
    • Creation of mock-ups
    • Braille verification
    • Readability user testing
    • Creation of risk management plans

Post-authorisation maintenance

 

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

Veterinary Pharmacovigilance

  • A Qualified Person responsible for
    Pharmacovigilance (QPPV) / Deputy QPPV services
    (24 hour cover)
  • Veterinarian Services

 

  • Full and ad hoc PV services including:
  • 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 (PSUR’s)
  • 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 preinspection
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