In the realm of pharmaceuticals, regulatory compliance is paramount to ensure patient safety. With the complex environment of safety reporting, several vendors may be involved at global and local levels for performing submission activities to health authorities, ethics committees and investigators. Director of UBC Global Case Processing, Myrto Ioannidi and UBC Team Manager, Esther Aparicio review why it’s important, what to consider and how to drive good collaboration between different vendors to ensure compliance.
Primarily, compliance relies on safety regulatory intelligence to identify global and local regulatory requirements. Creation and maintenance of core documents depends on different sources of information and for local vendors to overcome the challenges of language, non-availability of the information, and the number & diversity of the updates. Despite having a robust monitoring system in place, without a clear and consistent understanding of the regulations, the risk of non-compliance arises.
The path to building good collaboration between vendors starts with an early set-up, clear definition and understanding of responsibilities, exchange of relevant information, alignment on shared decisions, thorough documentation and team training.
At UBC, we promote collaboration versus competitivity as patient safety is a common goal for all parties involved. To build and maintain collaboration, it is important to follow key steps including a bi-directional sharing of information, the ability to trust the quality of information exchanged and open communication to reach inspection readiness with confidence that all regulatory requirements are met.
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 customized solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.
ABOUT THE AUTHORS:
Esther Aparicio, MSc
Team Manager, Global Case Processing
Esther Aparicio, MSc currently serves as Team Manager of UBC’s Global Case Processing. With over 10 years’ experience in the pharmaceutical industry, Ms. Aparicio has strong experience with processing clinical trial & post-marketing cases. She is responsible for operationalizing client-specific projects including case processing activities, regulatory compliance, workload organization, database configuration, output request review, procedures & plans review, literature monitoring, reconciliation activities, documentation of non-compliance, sponsor teleconference attendance and support of client audits & inspections. Ms. Aparicio is also a member of the Literature SMEs team at UBC. Ms. Aparicio holds a Master of Sciences in Pharmaceutical Biotechnology and Innovative Therapies from the University of Paris Sud (France).
Myrto Ioannidi, MSc
Director, Global Case Processing, Pharmacovigilance
Myrto Ioannidi joined UBC in 2013 and is currently leading a global team responsible for PV case processing, expedited reporting, literature, safety database configuration and aggregate data outputs. In her current role, Mrs. Ioannidi is involved in PV project management, process & operations set up, oversight and governance. Mrs. Ioannidi also acts as PV process lead for global and local literature, and case automation. Prior to joining UBC, Mrs. Ioannidi worked as Safety Manager and EU QPPV, overseeing a safety department and managing PV case processing and assessment, medical evaluation, training, literature review, SOP writing, auditing and set up of PV services & agreements. Mrs. Ioannidi also has experience in scientific research, in the field of Neuropharmacology. Mrs. Ioannidi holds a bachelor’s degree in animal biology and physiology from the University of Pierre et Marie Curie (Paris VI – France) and a MSc in Pharmacology from the University of Paris XI (France).
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