Pharmacovigilance – New
The Marketing Authorisation Holders of a medicinal product are obliged to monitor, collect, assess and report all adverse events during the post-authorisation stage of a medicinal product.
The services SustChem Engineering offers include:
Provision of a Qualified Person Responsible for Pharmacovigilance (QPPV)
Monitoring of all required procedures as defined by legislation
Drafting of Pharmacovigilance System Master File (PSFM File)
Preparation and drafting of the required Standard Operating Procedures (SOP)
governing all its procedures and obligations.
Registration of all Safety Data Exchange Agreements
The agreements are concluded between the Company and third parties, where pharmacovigilance responsibilities are foreseen.
Definition of the Pharmacovigilance Quality System
Definition of an organisational chart for persons responsible for pharmacovigilance
Within the company, but also in affiliated parties.
Registration of the company on the Eudravigilance online database
Registration of the company as an SME with the European Medicines Agency (ΕΜΑ)
The registration is made if the company meets all requirements.
Preparation and submission of Spontaneous Reports by Health Professionals
They refer to Greece (ADRs) and adverse events (ΑΕ) of medicinal products by QPPV.
Preparation, review and submission of Periodic Safety Update Reports (PSUR)
Provided that they are required based on the active substances of the medicinal products that are available in the Greek market.
Electronic registration of the approved pharmaceutical products in the Eudravigilance online database
(Article 57, Reg. 726/2004 EC) by certified personnel, within 15 days of the approval date of their release.
Check and approval of all pharmacovigilance agreements (Safety Data Exchange Agreements)
Between the Company and third parties, where pharmacovigilance responsibilities are foreseen.
Gathering and electronic submission, through Eudravigilance, of Individual Case Safety Reports (ICRS)
Round-the-clock contact person
Review and regular check of bibliographical references
It concerns local and global bibliography.
Signal gathering and tracking
Epidemiological analysis thereof and reference recording.
Preparation for inspections of the pharmacovigilance system
Provision of information to the Competent Authorities
In all cases regarding the safety of pharmaceutical products and especially when Post-Authorisation Safety Studies (PASS) are conducted.
Creation of a Risk Management Plan
Based on the Good Pharmacovigilance Practice (GVP) Directive, if it is deemed necessary.
Training of employees
Training of Company employees on pharmacovigilance issues.
