Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

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.

Steve Mayall is a Principal Consultant in Huron’s Life Sciences Practice (formerly known as Pope Woodhead). He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management for more than 15 years. Key areas have included developing risk management plans; designing, implementing and evaluating risk minimisation and pharmacovigilance activities; and performing structured benefit-risk assessments.

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.