Pharmacovigilance

Our company has many years’ tradition and background in pharmacovigilance services. The portfolio of services provided by us is developing and expanding constantly to meet the equally developing and expanding needs of our customers and applicable legislation. Owing to our well-established quality management system and periodic internal and external audits, we are a proven partner in the information world you can rely on. Use the services of the team of specialists, each of whom is a top expert in the field.

Service portfolio

• Global literature and database monitoring
• Local monitoring of active medicinal substances and medicinal products in medical and scientific journals (MLM) in accordance with GVP, in nearly all European countries
• Securing a Qualified Person Responsible For Pharmacovigilance (QPPV) and/or a Local Person for Pharmacovigilance (LPPV)
• Provision of a representative or support for LPPV or QPPV in any pharmacovigilance area
• Periodic Safety Update Report Periodic Safety Update Report (PSUR)
• We can compile a package leaflet (PL) and/or summary of product characteristics (SmPC) of a medicinal product for you
• We organise seminars and workshops, perform causality assessments, medical information assessment, case management, case narrative and follow-up
• Retrospective analyses and monitoring of international and local medical journals
• Single literature search and information concerning a specific topic (for PSUR, SmPC, etc.)
• Ensuring, support and updating of your quality management system (QMS) – preparation of an SOP for instance
• Cosmetovigilance-related services (cosmetic product safety monitoring)
• Materiovigilance-related services (medical device safety monitoring)
• Consulting, seminars, training courses
• Translation of papers and legislative information (package leaflets, PSUR, etc.)

Legislative basis

• Good Pharmacovigilance Practices (GVP) according to the European Medicines Agency (EMA)
  • Module VI (Collection, management and submission of reports of suspected adverse reactions to medicinal products)
• Regulation (EC) No. 726/2004 on the authorisation and supervision of medicinal products for human and veterinary use
• Regulation (EU) No. 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004
• Regulation (EU) No. 2017/745 on medical devices (Medical Device Regulation, MDR)
• Commission Implementing Regulation (EU) No. 520/2012 on the performance of pharmacovigilance activities
• Directive 2001/83/EC on the Community code relating to medicinal products for human use
• Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC
• Czech Act No. 378/2007 Coll., on medicinal products
• Czech Act No. 255/2012 Coll., on inspection (Inspection Code)
• Czech Act No. 500/2004 Coll., Code of Administrative Procedure
• Czech Regulation No. 228/2008 Coll., on medicinal product authorisation
• Czech Regulation No. 205/2018 Coll., amending Regulation No. 228/2008 Coll.
• Czech State Institute for Drug Control (SÚKL) guidelines (PHV)