Detailed analysis of the benefit-risk evaluation for a pharmaceutical product cannot be conducted at the level of ICSR submission. Periodic review of cumulative safety reports is important to determine the benefit-risk profile of a pharmaceutical product. These reports consist of detailed overview of data that the MAH has accumulated during consistent and critical monitoring of the product’s benefit-risk profile and adhere to ICH guidelines. Safety regulations and guidelines are ever evolving under aegis of stringent regulatory agencies like U.S. FDA and EMA. Thus, preparing aggregate reports require vigilant & diligent review of periodic data on ADRs and SAEs. The regulatory requirements for report submission frequency are different for each region. It is important to maintain constancy when submitting crucial safety data to avoid duplication of effort. Organizations face many challenges during the development of aggregate reports. Due to the wide range of documents involved, the process can be labour intensive and daunting. Additionally, high volumes of data bring high risks of error that could lead to non-compliance.
DDReg offers high-quality Pharmacovigilance Aggregate reports and addendums as per ICH/EMA/U.S. FDA requirements & templates. From pre-submission to post-marketing reports, our dedicated team of life science experts work in initial research, information collation, authoring, compilation, and submission to respective regulatory authorities and regulators across the globe. Our in-house tools and database allow efficient management and tracking of reports and mitigate potential errors.
DDReg’s Aggregate Report Expertise includes authoring, compilation, quality review and submission of :
- Periodic Benefit-Risk Evaluation Report (PBRERs)
- Periodic Safety Update Report (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
