Aggregate Report and Risk Management Plan

Compilation of safety and efficacy information of your medicinal products throughout their lifecycle

The impact of aggregate reports on maintaining your product’s risk-benefit profile

Throughout a medicinal product’s lifecycle, periodic safety and efficacy information must be accumulated and submitted to the health authority. These are known in the industry as aggregate reports and are regulated by EMA, USFDA, and International Council of Harmonization (ICH) guidelines. These reports provide an overarching insight into the risk-benefit profile of a medicinal product. The pre-approval reports, widely known as DSURs (Development Safety Update Reports), provide a baseline risk-benefit profile informing the patients of any potential adverse effects identified from non-clinical and clinical testing. The post-approval reports such as PSUR (Periodic Update Safety Reports) /PBRER (Periodic Benefit-Risk Evaluation Reports )/PADER (Periodic Adverse Drug Experience Reports) provide an extra layer of information considering real-world data, which can identify additional risks over time.

Our risk management team provides strategic advice on risk management plans for new submissions and supports MAH in compiling, reviewing, and updating risk management plans (RMPs).

At PLG, an expert team is always ready to support you with these reports.

PLG supports our clients through the following types of reports covering large regulatory landscape (EU, UK, USA, Australia, Canada and ROW countries):

– DSURs- PBRERs

– PADERs

– Addendum to Clinical Overviews (ACO) for renewals

– PSURs

– RMPs

– Annual Summary Reports (ASRs)

PLG offers to perform the following tasks in supporting the client’s aggregate reports:

– Due diligence of existing reports from clients

– Writing and review of reports

– Data analysis and risk-benefit evaluation

– Submission of reports to health authorities

– Responding to PSUSA and handling regulatory agency queries

– Providing support in audits and inspections to clients

PLG has many benefits regarding aggregate reports for our clients

PLG’s collaborative method of working with clients

Report writing is an integral part of drug development and for the entire life cycle of the drug. We have a dedicated team of healthcare professionals who work closely with clients to bring accurate, timely, and cost-effective deliverables. Meticulous attention to detail, strict adherence to timelines, and a flexible and first-time-right approach: this operational discipline is demonstrated following the common practice below.

PLG has a superior Quality Management System

Our QMS ensures supervision of timelines, KPIs, deviation management, change management, and CAPA effectiveness: timelines are checked and monitored by appropriate tools, and deviations (CAPAs) are managed and tracked by our quality assurance personnel. We ensure the confidentiality and security of all data and documents.

Our communication and flexibility are our main asset

Our in-depth collaborative discipline is demonstrated in regular communication before and throughout each project. Kick-off meetings, regular teleconferences, and effective on-time email communications ensure all team members can access relevant information throughout the project.

We have interactive project management

In conjunction with other services provided by PLG, our project managers ensure that each project’s scope, timelines, resources, and budget are well-defined and realistic. They follow each project throughout its lifecycle and inform the client of progress.