Pharmacovigilance Without Borders

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.

Prof Saleh Abdullah Bawazir, Bawazir Pharma Consult Center, Saudi-Arabia

For more than 12 years Prof Bawazir worked as an advisor to the Executive
Office for the Health Ministers of the Arabian Countries on the Gulf.
During his work he chaired the commitiee that revised and updated the
pharmacy law and updated drug registration procedures. He also represented
the Ministry of Health in the national commitiee that negotiated Saudi
Arabia‘s accession to the World Trade Organization (WTO) and the commitiee
that established the Saudi Food and Drug Authority (SFDA). Prof Bawazir is
considered an authority in pharmaceutical regulations in Saudi Arabia and the
GCC. Prof Bawazir has more than 200 publications and presentations in
scientific meetings and journals and three books.