SG Consulting has the experience and expertise to deliver support services to clients for the development and maintenance of the pharmacovigilance system in compliance with applicable EU and local national legislation, regulations, and Good Pharmacovigilance Practice (GVP).
In accordance with Article 103 of Directive 2001/83/EC and as described in Module 1 of the EU Guideline on GVP, the EU QPPV services include:
Local Contact Person for the European and German Competent Authorities on pharmacovgilance matters, i.e. Federal Institute for Drugs and Medical Devices, Germ. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Paul Ehrlich Institute, and Drug Commission of the German Medical Association, Germ. Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ).
Maintaining the safety profile of products by providing input into the preparation of regulatory action in response to safety concerns, for example variations, safety restrictions, and communication to patients and healthcare professionals;
24-hour designated point of contact for the regulatory authorities;
Responding to regulatory authority communications on safety queries;
Review of cumulative, global safety reports (e.g. PSURs, PBRERs) according to the Good Pharmacovigilance Practice (GVP) - Modules VI, VII and IX, including interpretation of the aggregate data, and qualitative and quantitative evaluation of the benefit / risk of medication in various patient populations;
Review of Risk Management Plans (RMPs) according to the GVP Modules V and VI;
Writing, updating and registering the Pharmacovigilance System master File (PSMF) in accordance with EU Requirements.