Risk management is a proactive and continuous process throughout a product lifecycle to optimize the benefit–risk profile through a cross-functional team to ensure aligned safety strategies.
As a former Deputy EU QPPV and head of medical safety evaluation, Rudi co-authored, reviewed, and approved Risk Management Plans for a variety of products, including products with restricted distribution, post-authorisation safety studies, a disease / patient registry, educational material, a patient card, and additional clinical studies. Drawing on his clinical expertise and pharmacovigilance experience, he ensures that that effective risk minimization tools are used and that proposed activities are scientifically sound, proportionate, and patient-focused.
During a due diligence, based on limited data during early development, Rudi assesses whether any additional risk minimization measures might be required and supports the business team to assess the impact (e.g. costs, impact of risk minimization measures on the size of the target market population).