Post-Authorisation Safety Studies (PASS)
Post-Authorisation Safety Studies (PASS)
Designing and conducting post-authorisation safety studies (PASS) throughout Europe
UBC’s experts combine deep scientific knowledge with industry and regulatory experience to design PASS protocols for both mandated and non-mandated PASS.
UBC is an industry leader in designing and conducting post-authorisation safety studies (PASS) in Europe. Our staff has in-depth knowledge of:
- Good pharmacovigilance practice
- International Society of Pharmacoepidemiology (ISPE) guidance European Network of Centres for Pharmacoepidemiology
- Pharmacovigilance (ENCePP) methodological standards
We leverage our experience of interacting with the Pharmacovigilance and Risk Management Committee (PRAC) to ensure protocols are written to achieve PRAC approval with minimal delays.
Our PASS protocol design services include:
PASS protocol development
Consideration of most appropriate study design to:
- Address safety concerns
- Meet sponsors requirements
- Align with safety specifications and pharmacovigilance plan within the RMP.
- Clear, concise protocol in EU PASS template to meet the requirements of the PRAC
Careful consideration of the appropriate variables to
- Meet study objectives
- Not place undue burden on busy clinicians
- Clear Data Analysis Plan to meet PRAC requirements at first review
- Consideration of most appropriate study design to:
- Registration on EU PAS Register
- Responding to PRAC questions
- Study progress reports
- Interim reports
- Final study reports
UBC employs a multidisciplinary operational team of highly qualified individuals with extensive and strong observational global operations research experience to ensure the rapid, efficient, and cost-effective completion of each PASS.
UBC addresses a number of key factors to ensure operational success:
- Data collection that is aligned with the study design and goals
- Engaging an operational team that ensures the rapid, efficient, and cost-effective completion of each program
- A detailed feasibility assessment including key questions that outline a roadmap for site identification
- An in-depth understanding of the country, region, and site-specific requirements that can help navigate the processes necessary to obtain authorization for international PASS programs
Site management and tools
- Well-established relationships with sites that ensure a continuous connection over a number of years
- Technology that allows for rapid data capture, tracking, review, and processing, resulting in reduced data cleaning timelines and easily understandable metrics to track progress
UBC understands the challenges associated with conducting observational studies throughout Europe. We design PASS that can be implemented successfully across the European countries by leveraging our in-depth knowledge of the regulatory and ethics committee requirements and ensuring that the variations in clinical practice are accommodated.
- Geographical Considerations: We work with sponsors to define realistic study timelines based upon regulatory approval of the medicinal product, reimbursement, incorporation of the medicinal product into national/local guidelines, and the time required for any applicable regulatory and ethics committee approvals.
- Designing non-interventional observational studies: Using their experience in design and execution of these studies across Europe, the UBC team can work with sponsor to identify the key variables that will meet the objectives of the study and fall within normal clinical practice across the various EU countries. Careful consideration of the variables minimises the burden to the investigator, reduces missing data, and can be key to the success of the study.
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 in the International Society of Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconmics and Outcomes Research (ISPOR). .
Commitment to Success
UBC has designed and implemented a range of PASS, including:
- Large EU registries such as a 30,000-patient registry for Alzheimer’s disease and a registry for multiple sclerosis that includes 350 sites
- Small prospective observational studies in orphan indications, including Crohn’s disease, adult chronic myeloid leukemia, renal cell carcinoma, and juvenile rheumatoid arthritis
- Retrospective chart review studies
- Drug utilisation studies
- Physician and patient surveys to assess effectiveness of risk minimisation activities
Contact us to let our experts design and implement a PASS that receives swift PRAC approval and generates the real-world safety evidence you need.