Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse event or other medicinal products related problem.
European Parliament and Council of Ministers has adopted Directive 2001/83/EC and Regulation (EC) No. 726/2004 as amended, accompanied by Commission Implementing Regulation No. 520/2012 to regulate pharmacovigilance activities in European Union.
Sveikuva standardised working procedures and processes, based on we developed pharmacovigilance system in compliance with Good Pharmacovigilance Practice guidelines. For it was very important, that our pharmacovigilance system is created in a way to maintain ability to seamlessly integrate into client’s pharmacovigilance systems. Every year Sveikuva pharmacovigilance system is audited by clients and/or external auditors. In addition, Sveikuva have established GDPR policy to assure proper management of personal data.
Qualified Person responsible for Pharmacovigilance (QPPV)
Following Directive 2001/83/EC Article 104 marketing authorisation holder/applicant shall have EU QPPV at his disposal.
Sveikuva provides EU and national level QPPV(s) and/or deputy QPPV(s) as a service. QPPV functions may include all or part of functions described in Good Pharmacovigilance Practices Module I, section I.C.1.3, including:
Pharmacovigilance consulting
Sveikuva can provide local pharmacovigilance support in Central and Easter European countries:
Sveikuva provides advanced pharmacovigilance support for establishing and maintenance of EU pharmacovigilance system for marketing authorisation holders and applicants.
Sveikuva can provide advanced pharmacovigilance support:
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse event or other medicinal products related problem.
European Parliament and Council of Ministers has adopted Directive 2001/83/EC and Regulation (EC) No. 726/2004 as amended, accompanied by Commission Implementing Regulation No. 520/2012 to regulate pharmacovigilance activities in European Union.
Sveikuva standardised working procedures and processes, based on we developed pharmacovigilance system in compliance with Good Pharmacovigilance Practice guidelines. For it was very important, that our pharmacovigilance system is created in a way to maintain ability to seamlessly integrate into client’s pharmacovigilance systems. Every year Sveikuva pharmacovigilance system is audited by clients and/or external auditors. In addition, Sveikuva have established GDPR policy to assure proper management of personal data.
Qualified Person responsible for Pharmacovigilance (QPPV)
Following Directive 2001/83/EC Article 104 marketing authorisation holder/applicant shall have EU QPPV at his disposal.
Sveikuva provides EU and national level QPPV(s) and/or deputy QPPV(s) as a service. QPPV functions may include all or part of functions described in Good Pharmacovigilance Practices Module I, section I.C.1.3, including:
Pharmacovigilance consulting
Sveikuva can provide local pharmacovigilance support in Central and Easter European countries:
Sveikuva provides advanced pharmacovigilance support for establishing and maintenance of EU pharmacovigilance system for marketing authorisation holders and applicants.
Sveikuva can provide advanced pharmacovigilance support: