Pharmaceutical Risk Management Europe
European Risk Management
Designing effective risk management programmes that satisfy the multiple regulatory agencies and healthcare systems in the European Union
UBC is unequalled in its mastery of risk management. Our experts have extensive experience in writing complex Risk Management Plans (RMPs), creating and implementing a broad range of risk minimisation activities and evaluating their effectiveness.
UBC is the only provider that can span the risk management continuum of needs for your product. Our employees are the most experienced in their fields, and they provide expert consulting from pre-approval through post-marketing. Key elements for anticipating a product’s needs, as well as the appropriate tools to address those needs, come from disciplines in clinical medicine, epidemiology, public health, regulatory and pharmacovigilance sciences.
Our services include:
Development of Risk Management Plans
- Writing Risk Management documents compliant with EU guidelines
- Strategic consulting, negotiating with regulatory agencies
- Designing risk minimisation programmes to meet regulatory requirements and industry objectives whilst ensuring prescriber and patient acceptability
- Designing Post-Authorisation Safety Studies (PASS) such as disease or product registries
- Developing and testing of educational tools
- Models for controlled distribution
Development of methods to assess effectiveness of risk minimisation activities
- Retrospective chart reviews
- Drug utilisation studies (DUS)
- Registries and cohort studies
Designing and conducting knowledge, attitude, and behavior surveys of patients and prescribers
- Questionnaires and protocols – sample size, recruitment methodology, response measurements
- Survey implementation – online, personal and telephone interviews
- State-of-the-art web survey system
- Computer-assisted telephone interviews (CATI)
- Compliant systems: EudraLex Annex 11
- Comprehensive results analysis
- Performance-linked access systems (ePLAS) and controlled distribution
As a leader in risk management, UBC has the experience and industry knowledge to guide companies through these regulatory systems.
UBC is a partner centre of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) scientific network which is coordinated by the European Medicines Agency. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We register studies in the ENCePP E-Register of Studies, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.
UBC actively participates in ENCePP and International Society of Pharmacoepidemiology (ISPE) activities and workshops to maintain cutting edge knowledge.
Contact us to discuss your risk management needs.