This scientific presentation was held by Dr Ulrike Treichel, Head of Pharmacovigilance at ICRC-Weyer, at the Evolution Summit in Munich
Though increasing regulation prompting a stronger focus on pharmacovigilance, many risk management strategies are still lacking the efficiency needed to keep pace with market and regulatory developments. Most pharmacovigilance systems suffer either from a complete lack of medical review integration or, at the other extreme, a single all-inclusive process resulting in over-integration. In this masterclass presentation, Dr Ulrike Treichel reveals her experiences in striking a balanced medical review process to build a robust pharmacovigilance strategy.
• Assessing current risk management approaches to pinpoint drawbacks and improve pharmacovigilance strategies
• Identifying the expected benefits, potential difficulties and practical considerations of medical review for effective integration
• Examining past case studies to uncover unforeseen threats and debunk false risks
• Improving processes and minimising overall risks through the successful execution of integrated medical review
Prior to joining ICRC-Weyer, Ulrike Treichel had worked several years as a research associate and postdoctoral fellow at the Charité in Berlin (Campus Benjamin Franklin). She has long-term experience in the field of oncology. Her postgraduate (degree) studies in clinical trial management provides her with indepth knowledge of the regulatory requirements of clinical trials.