In the realm of pharmaceuticals, regulatory compliance is paramount to ensure patient safety. Pharmacovigilance (PV) and Risk Management Plans (RMPs) serve as vital tools in this landscape, guiding companies in identifying, assessing, and mitigating potential risks associated with medicinal products.
PV encompasses a range of activities, from timely data collection and reporting to signal detection and risk mitigation. The foundation lies in meticulous data assessment and adherence to regulatory requirements.
RMPs document a product’s risk management system, outlining strategies to identify, characterize, and minimize risks. Mandated by regulatory bodies like the EuropeanMedicines Agency (EMA), the developmental phase of an RMP begins prior to clinical trials, evolving as new data emerges and are essential components of marketing authorization applications.
Navigating RMP requirements across regions demands a comprehensive understanding of global regulatory frameworks. Companies must proactively identify country-specific guidelines to tailor RMPs accordingly.
Issues can arise during RMP development. In particular, delays in document provision and coordination hurdles underscore the importance of clear communication and commitment across departments. Collaboration across departments is vital, with stakeholders contributing expertise to ensure accuracy.
Achieving global harmonization in PV & RMP compliance demands collaboration, communication, and dedication. By leveraging expertise, adhering to regulatory guidelines, and embracing best practices, companies can ensure high-quality RMPs that prioritize patient safety on a global scale.
In conclusion, the journey towards PV & RMP regulatory harmonization is multifaceted, requiring companies to navigate intricate regulatory landscapes with diligence and expertise. Through proactive collaboration and adherence to best practices, companies can streamline processes, enhance compliance, and ultimately safeguard patient well-being on a global scale.
ABOUT UBC:
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Our combined scientific expertise in pharmacovigilance, risk management, and signal detection and assessment, underpinned by innovative technologies, offer our customers flexible solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.
For more information on UBC’s comprehensive global pharmacovigilance services, get in touch with us HERE.
ABOUT THE AUTHORS:
Philippe Botteron, MD, Senior Safety/Project Physician, Pharmacovigilance
Dr. Botteron has 8 years of experience in the pharmaceutical industry. He serves as a Senior Safety/Project Physician. In this role, he performs medical review of individual cases or safety reports, participates in writing periodic safety reports, performs signal detection and management, and writes company documents (e.g. CCDS) and regulatory documents (e.g. RMP). His fields of expertise are Oncology, Immunology, and Infectious Diseases. He received his medical degree from the University of Geneva.
Helena Pedrosa, PharmD PhD, Associate Director, Global Case Processing
Dr. Pedrosa joined UBC in October 2012 and has 11 years of experience in the pharmaceutical industry. She acquired experience at UBC as a Safety Data Associate, Safety Scientist and Team Manager for multiple clients. Dr. Pedrosa has a proven record in end-to-end case processing of clinical trial and post-marketing cases and regulatory compliance and is a subject matter expert for scientific literature monitoring for PV. She currently manages several operational teams performing end-to-end case processing, expedited reporting, literature monitoring, safety database configurations and output requests, reconciliation activities, and local PV activities. She holds a Pharm D and a PhD in Toxicology from University of Porto (Portugal).
