Pharmacovigilance legislation in Europe requires a long-term plan to capture, store and process safety data to enable potential signals to be identified from early development to post-marketing.
We can help you collect, store and report adverse events during clinical trials and post-marketing by means of dedicated systems and specialised consultants, like Local Contact Persons or QPPVs in EU and UK.
We also manage the full monitoring and data collection process, from adverse reaction to signal detection, reporting and analysis. Plus, we can assist in authoring key documents like DSURs or PSURs, PBRERs to maintain compliance with the regulatory requirements.
Periodic Benefit Risk Evaluation Submissions (PBRER)
Detailed periodic benefit risk evaluation reports (PBRER) are required from you once your pharmaceutical product is approved. A PBRER details the overall benefit/risk profile of the product and is assessed by EMA.
PBRER applications are extremely important and they come under extreme inspection and examination by PRAC or NCAs. Any inconsistency can result in penalisation and time intensive further examination and analysis.
Pharma Design Limited helps you write your PBRER, offers assistance with synchronisation of DSUR/PSUR submissions and timeline management.
Risk Management Plans (RMP)
Pharma Design Limited can project manage specific and targeted safety documents for your pharmaceutical product. RMPs need to be maintained as living documents and submitted for marketing authorisation and renewals. We can write RMPs or help your staff reviewing one, we can advise and assist you in the submission of your risk management plan.
An RMP will detail any potential or identified risks and has to be consistent with Company labeling information (IBs, RSI, CDS) and other safety documents like periodic safety reports.
Development Safety Update Report (DSUR)
Pharma Design Limited have expert knowledge and experience in this area and we can ensure that your DSUR will be accurately and efficiently completed.
Having a well organised, efficient safety reporting path from studies is a pivotal requirement for product development and is also an opportunity to save time and money. Once signed, safety monitoring plans are unlikely to be amended without incurring high costs. Pharma Design Limited offers assistance in drafting, reviewing, finalising and submitting annual DSURs on behalf of the sponsor.
Integrated Safety Summary (ISS) or Clinical Summary of Safety
An integrated/clinical safety summary is an integral part of some, more complex, pharmaceutical product submissions. This critical document has become increasingly important as authorities become more and more vigilant over the safety of pharmaceutical products before they are approved.
In order to avoid delay, the ISS/CSS needs to be a uniform and comprehensive document regardless of the obvious differences in the sources from which it is produced. Pharma Design offers assistance with the production, review and quality control of the integrated safety summary.
For more safety advice on pharmaceutical products, call Pharma Design Limited on +44(0)755 798 3864 today. Alternatively, please complete our online enquiry form and one of our pharmaceutical consultants will be in touch within 24 hours
Our Values
The value we bring to pharmaceutical companies falls into four main areas:
- Objective, impartial advice tailored to your needs
- Help cut your development costs
- Help reduce your time to market
- Keep your drug on the market