UBC is unequaled in its mastery of Risk Management Plan (RMP) requirements. Our experts have created complex RMPs, not only in the EU but also in other territories worldwide where an RMP is required for regulatory approval.
Our experience encompasses a broad range of therapeutic areas including rare diseases and pediatric indications. We are at the forefront of RMP development for advanced therapy medicinal products (ATMP) such as biologics, cellular immunotherapy, genetically modified T-cell therapies, and vector-based gene therapy.
Not only is UBC aware of the local requirements for RMP content, our experience over many years means that we understand the nuances of these regulations and how they are interpreted by regulators. We can partner with you to implement an RMP that will meet regulatory expectations and minimize questions during the review period.
Further, there is an increasing focus by regulators on the importance of evaluating the effectiveness of risk minimization activities. We have designed and implemented multiple evaluation studies, with maximum efficiency and minimal burden to healthcare professionals, patients, and sponsors.