Pharmacovigilance Quality Management Training

Dr Bianca Scholz, Managing Director, ScholzPharma GmbH

Bianca is Managing Director of Scholzpharma GmbH since 2008 and advises clients in the areas of GVP, GCP, GLP, GDP and GMP as well as ISO with a focus on quality management, audit and inspection worldwide. Prior to founding her own company she worked for Baxter Healthcare (2002-2008) as Quality Manager/Auditor in the Team of Corporate Compliance Services. She was Lead Auditor for Pharmacovigilance audits (GVP) and audits of clinical trials (GCP) and supported the Team as Subject Matter Expert in other GxP fields (GMP, GLP, GDP).

Bianca is DGQ/EQO certified auditor, specialised pharmacist for drug information and carries out numerous audits in the field of GxP/ISO (including inspection preparations/"inspection readiness"). Bianca prepared, supported and attended as a consultant several inspections by Competent Authorities worldwide covering the Asian, European and US market.

Susan Timeus, Head of Drug Safety, Tillotts Pharma AG

Susan is the team lead of Tillotts Pharma AG in Switzerland. She has been working in the area of Drug Safety since over 20 years. She leads a team responsible for implementing and maintaining a GVP compliant system for products marketed in the Switzerland, EU, UK and worldwide via partners. She manages all operational functions within the Pharmacovigilance department including preparing and maintaining Standard Operating Procedures (SOPs), risk-based Audit Strategies, ICSRs reporting including compliance monitoring, aggregate reporting, signal detection processes, Literature searches and monitoring, Pharmacovigilance Agreements, Risk Management Plans and Pharmacovigilance System Master File (PSMF).  She provides expertise on how companies can implement and maintain a robust PV system.