Pharmacovigilance Requirements in China - LATAM - Russia - MENA

Deputy General Director "Technical Affairs"
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Karin van der Auwera studied English and German at the University of Stuttgart and at Tulane University, New Orleans. For six years she ran a private language school in Stuttgart. Since 1989 she has been training business professionals teaching international communication and cultural competence. Karin van der Auwera's clients include a broad range of multi-national companies throughout the European Union and the USA.
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Regional PV Head Africa & Asia Alessandra has 14 years of experience in Pharmacovigilance. She worked for Sanofi and Boehringer Ingelheim in Brazil where she acted as PV Head and Qualified person for local HA being responsible to stablish and maintain a PV system compliant with emergent local legislations and global standards. Since Mar 2019, as a Regional PV Head located in Germany, she is responsible for PV in China, South East Asia and South Korea, India, Middle East and Africa countries. In this period, she actively contributed to the implementation of new regulatory requirements of emerging markets such as the Institutional Reform of China State Council.

Medical Director; Anna has more than 15 years of experience in Pharmaceutical industry in Regulatory affairs and about 8 years in PV. She has background in Organon, Bayer-Schering and Sanofi. After joining Eisai Russia she had to build PV system from the scratch and reform it after EAEU GVP introduction. PV system successfully passed several internal audits.

Associate director and back-up of PV Country Lead in Brazil Raphael has more than 10 years of experience in Pharmacovigilance, beginning his career at Sanofi, where he acted in roles of increasing responsibility within local PV organization, responsibilities included oversight of case management, PSUR management to comply with Brazilian regulation and RMP management. He served as Deputy for PV Head in Sanofi Brazil, Genzyme, Sanofi Pasteur (vaccines) and Medley (generics) Raphael also worked for Johnson & Johnson for 2 years as associate manager, with responsibility for 18 countries within Latin America in processes like PSURs management to comply with LatAm requirements, PV Agreements management, oversight of expedited reporting to Health Authority and of contracts with vendors and business partners related to Pharmacovigilance. The activities are related to drugs, devices and cosmetics. Since January 2018 Raphael is working at Merck & Co (MSD) as Associate director and back-up of PV Country Lead in Brazil.

Head Global Patient Safety Neurology & Immunology; Dr Tanja Peters is a clinical pharmacologist with over 22 years experience in pharmaceutical industry; She has worked in various positions in Research & Development, Regulatory Affairs and Pharmacovigilance at Merck KGaA and Boehringer Ingelheim. During her 8 years as Deputy EU-QPPV & Head PV Intelligence at Boehringer Ingelheim she implemented EU-GVP, developed the company’s PSMF, and built a PV Intelligence network in coorperation with the regional PV organisations to oversee, analyse and implement new pharmacovigilance requirements into local and global PV Systems.