The new pharmacovigilance legislation introduced many new requirements for established products and has better defined processess and standards of quality. You now need a consistent system to store all your safety data to enable potential signals to be more easily spotted and also, even more importantly, a thorough internal assessment of your own comprehensive safety data.

PhD has a range of services to monitor the safety of your product and help you understand and define its safety profile. We can assist you in transitioning and complying with the new legislation. We can also provide you with an experienced Qualified Person (QPPV) as required.

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 design or rework critical processes so you can be rest assured you are compliant 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 helps you write your PBRER, offers assistance with synchronisation of DSUR/PSUR submissions and timeline management in order to ease last minute stress on any specific department.

Risk Management Plans (RMP)

Pharma Design 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)

Safety monitoring plans and annual safety reports are part of the safety requirements during clinical development. A DSUR must be produced and submitted to competent authorities and ethics committees.

Pharma Design 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 offers assistance in drafting, reviewing and finalising 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 most 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 PharmaDesign on +44(0)20 3875 4111 or +353 (0)1 902 0049 today. Alternatively, please complete our online enquiry form and one of our pharmaceutical consultants will be in touch within 24 hours