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Pharmacovigilance – Global aggregate report development

GAP has a qualified team of aggregate safety physicians that work with you to prepare global regulatory aggregate reports on continuous basis per regulatory guidelines. The GAP group has the expertise in both pre and post marketing drug safety regulations, worldwide market authorization applications, variations and renewals and carefully developed due diligence systems. GAP can design and lead all global regulatory report generation and submission services in alignment with electronic or paper submissions. Various documents provided under these services are PSUR, PADER, PBRER, ASR and DSUR.

PSUR (Periodic Safety Update Report): The PSUR for marketed product is intended to provide an update on comprehensive assessment of the world wide safety incidents to competent authorities in European Union (EU) at defined time points post authorization. It is an important source for detection of new signal or strengthening of already detected signals. They act as a factor for identification of changes in risk benefit ratio and an effective means to communicate it to the competent authorities.

PADER (periodic adverse drug experience report): PADER is similar to PSUR, which is required by US FDA. The purpose is to report the entire adverse events for post marketed drug in the defined time period. Each applicant needs to submit a quarterly report within 30 days of the end of quarter and annual report within 60 days of anniversary date of approval of the application.

PBRER (Periodic Benefit-Risk Evaluation Report): PBRER is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. Regulators from EU, Japan, and the US believe that the PBRER may be used to meet prevailing national and regional requirements for periodic safety and/or benefit-risk reports for approved medicinal products.

ASR (Annual Safety Report): ASR is a consolidated report for the all new safety incidents pertinent to one or several trials and to evaluate the safety condition of subjects participating in that trial. According to Article 17(2) of Directive 2001/20/EC, the sponsor shall provide all suspected serious adverse reactions for a defined reporting period to the Member States, in whose territory the clinical trials is being conducted, and the Ethic Committees every year ,with a listing.

DSUR (DEVELOPMENT SAFETY UPDATE REPORTS): DSURs are comprehensive and solicit annual reports which include evaluation of safety occurrence of a drug under clinical development phase collected for defined period. US FDA and EU clinical trial directive emphasize on periodic analysis of safety information in the form of IND Annual Report and Annual Safety Report respectively. They have different formats, contents and reporting timelines.