Pharmacovigilance & Pharmaceutical Safety
Safety & Pharmacovigilance
Pharmacovigilance (PV, PVG or PhV) is the process and science of detecting, assessing and preventing long and short term medical side effects in pharmaceutical and medical products. PharmaDesign will collect, monitor and evaluate information from clinical trial studies and marketed products . Call 020 7873 2178 or complete our online enquiry form for expert advice and assistance in safety and pharmacovigilance.
Long Term Assistance
PharmaDesign can provide you with long term assistance with daily pharmacovigilance activities like case triage, case processing, data entry, medical review and CIOMS I form production.
Every pharmaceutical regulatory authority encourages proactive case-clarification, and PharmaDesign can advise and assist you in this area. We offer a fully bespoke service with experienced safety scientists, 100 % Quality Control, medical review, reconciliation and tracking of all cases from any source (spontaneous and clinical). PharmaDesign provide accurate follow up and query generation services from the initial case study right through to a fully clarified CIOMS I document from clinical studies or spontaneous reports.
Periodic Pharmaceutical Submissions (PBRER)
Detailed periodic benefit risk evaluation reports (PBRER) are required from you once your pharmaceutical product is approved. The rules and regulation change once your product gains marketing authorisation. A PBRER details the overall benefit/risk profile of the product and specific and accurate submission is a must. There are strict deadlines to adhere to as well as complicated and thorough documents to complete.
PBRER applications are extremely important and they come under extreme inspection and examination by PRAC. Any that fail to properly examine the safety of the product can result in penalisation and time intensive further examination and analysis.
PharmaDesign offers updated calendars for submissions and timeline management in order to ease last minute stress on any specific department.
Risk Management Plans (RMP)
PharmaDesign can project manage specific and targeted safety documents for your pharmaceutical product. RMP needs to be submitted for marketing authorisation and a vast number of regulations need to be followed. We can advise and assist you in the submission of your risk management plan as well as the content that needs to be supplied.
A RMP will detail any potential or identified risks and if necessary, we can provide you with specialist pharmacovigilance information. PharmaDesign can help you to avoid further risks and we can ensure that there will be no delays due to insufficient plans.
Development Safety Update Report (DSUR)
Safety monitoring plans and annual safety reports are essential. The DSUR is submitted to regulatory bodies during the clinical trial period. A DSUR must be presented each year and for marketed pharmaceutical products, submitted from the date authorisation was granted.
This report should detail new safety information as well as the safety of any participant in the clinical trial. PharmaDesign 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 safety reports on behalf of the sponsor.
Integrated Safety Summary (ISS)
An integrated 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 and restrictive over the safety of pharmaceutical products before they are approved.
In order to avoid delay, the ISS needs to be a uniform document as much as possible regardless of the obvious differences in the sources from which it is produced. PharmaDesign offers assistance with the production, review and quality control of the integrated safety summary.
For more safety advice on pharmaceutical products, call PharmaDesign on 020 7873 2178 today. Alternatively, please complete our online enquiry form and one of our pharmaceutical consultants will be in touch within 24 hours