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Holiday Inn London Kensington Forum

2018 年 11 月 29 日 12:30 下午 - 2018 年 11 月 30 日 4:30 下午

97 Cromwell Road, London, SW7 4DN, United Kingdom

Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)

NEW OFFERING! This course introduces essential aspects of medical writing of aggregate safety reports in the context of current legal framework in the EU and globally.

讲师团队

Ruth  Luther, MPHARM, RPH

Ruth Luther, MPHARM, RPH

Director, Pharmacovigilance Excellence , Astrazeneca UK Ltd, United Kingdom

Ruth is a registered pharmacist who joined AstraZeneca in 1999 after completing her pre-registration training in hospital pharmacy. After several years working in a number of formulation development and regulatory CMC roles, she joined the Pharmacovigilance department in 2007. Ruth worked in the Safety Surveillance Group before moving on to become the process owner for a number of Pharmacovigilance processes including Safety Surveillance and Risk Management. Currently Ruth is a Pharmacovigilance Excellence Expert where, since 2017, her main responsibilities include support to the EU QPPV on process related matters and leading continuous improvement projects relevant to the content quality of key Pharmacovigilance deliverables.

Zuzana  Vinterova, PHD

Zuzana Vinterova, PHD

Strategic Advisor, Medical Writing, PrimeVigilance s.r.o., Czech Republic

Zuzana Vinterova received her PhD in Biochemistry from Charles University in Prague and she worked as a researcher at the Institute of Organic Chemistry and Biochemistry within the Czech Academy of Sciences, focusing on the major virulence factors of pathogenic yeasts (Candida spp.). Zuzana has joined PharmInvent (rebranded to PrimeVigilance in 2018) as a scientific specialist and medical writer and has now over 10 years of experience in medical writing of pharmacovigilance (PSUR/PBRER, DSUR, ACO, RMP) as well as regulatory science documents, needed throughout the full life-cycle of medicinal products.

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