Safety and Medical Writing

With a proven track record of preparing over 1500 aggregate reports and risk management plans (RMPs) each year, our experts can handle all Aggregate Safety Reporting (ASRs) obligations during clinical development, before the first clock-stop and after the first global marketing authorization. We have prepared integrated reports to serve numerous territories and varying levels of clinical R&D and registration by changing for example the DSUR DLP to coincide with the International Birth Date (IBD) of a marketed product which undergoes clinical development, to synchronize the DSUR and the PSUR.

At PrimeVigilance we understand the importance of timely and accurate drug safety reporting and communications with the regulatory agencies. Compliance is ensured through the preparation, medical review and submission of a wide range of aggregate reports, in both ICH and non-ICH formats.

We have been involved in the preparation of:

• Development Safety Update Reports (DSURs) that can be either product- or study-specific; the latter are applicable under special circumstances e.g., in combination therapies
• Periodic Safety Update Reports (PSURs) for medicines and medical devices
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Periodic Adverse Drug Experience Reports (PADERs) or Addendum to the Clinical Overviews (AddCOs) seeking to inform module 2.5 for MA renewals
• RMPs and subsequent updates through variations, following the EU template and regional modifications or additions, such as GB/UK-specific RMP annex, Australia-specific annex (ASA), addendum to EU-RMP serving for eCTD submission to Health Canada
• REMS incl. and REMS revisions, minor or major REMS modifications, submitted as post-authorization studies (PAS)
• Risk evaluations as part of Clinical Evaluation Reports (CER) and ‘inform’ post-market clinical follow-up (PMCF) plans of medical devices.

We have the knowledge to provide efficiencies and streamline processes across multiple jurisdictions. Our pharmacovigilance experts will:

• Lead or support the risk management planning in both pre- and peri-approval and post-market settings
• Help navigate the development of risk minimization measures (RMM) with an implementation scheme, specific tool recommendations and an evaluation strategy
• Align your risk mitigation processes across multiple geographies of different regulatory frameworks by assisting to evaluate the benefit-risk balance of your products and evaluate the need for product safety information changes.