Services

Pharmacovigilance

Pharmacovigilance

Ana Ivanovska, MPharm,PgDip

Head of Pharmacovigilance Department

Our Pharmacovigilance professionals offer PVG support, which can include global and/or local PV services.

PV for Marketed Products

Our Pharmacovigilance professionals offer:

  • Expert advice on PV system requirements
  • Providing Qualified PV personnel (a QPPV, QPPV deputy, local PV contact and medically qualified personnel)
  • Development, implementation and maintenance of the PV system
  • Preparation and maintenance of PSMF
  • Preparation and maintenance of Pharmacovigilance SOPs and other controlled quality documents
  • Preparation or review of PV agreements or safety data exchange agreements with business partners
  • A safety data receipt and processing
  • Signal detection and evaluation
  • Regular worldwide and local literature screening for case reports and other safety information
  • Electronic- or paper-based reporting to EMA and European competent authorities
  • Preparation of Periodic Safety Update Reports, Summary Bridging Reports, Addendum Reports, and other Aggregate Safety Reports
  • Risk Management Plans
  • PV trainings for PV and non-PV personnel
  • Creation of XEVPRMs
  • PV Audits, preparation of Corrective Action Plan, implementation of CAPA
  • Labelling evaluation and variations
  • Crisis management

 

We can also offer our support in PV for veterinary products.

PV for Clinical Trials

Clinres Farmacija offers complete drug safety development services during clinical trials including:

  • Service of experienced professionals (responsible person for pharmacovigilance, and back-up),
  • Registration with Eudravigilance Clinical Trial Module,
  • Establishment of Standard Operating Procedures (SOPs) on clinical trial pharmacovigilance and other controlled quality documents,
  • Management of cases and case processing (SAE),
  • SAE medical review, MedDRA coding,
  • Safety data reconciliation,
  • Preparation and submission of Development Safety Update Reports,
  • Preparation and submission of periodic SUSAR reports,
  • Electronic reporting of Suspected Unexpected Serious Adverse Events (SUSARS),
  • Reporting to Regulatory Authorities and Ethics Committees as appropriate,
  • Supporting assessment of risk-benefit ratios throughout the trial and updating the Investigator Brochure as necessary,
  • Developing of risk management plans in full compliance with regulations.

 
We offer dedicated phone and fax lines which enable you to personally contact a safety officer.