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Expedited reports

Electronic Reporting of Suspected Unexpected Serious Adverse Events (SUSARS) is now mandatory in many global territories.

As part of the service PrimeVigilance offers the facility to delegate the onerous task of registration and set up of the electronic reporting routes for the pharmacovigilance system. Experienced and EMA trained personnel ensure that expedited reporting meets the regulatory requirements in each trial territory. Whether electronic or hard copy PrimeVigilance offers consolidated expedited reporting services.

WHAT IS EXPEDITED REPORTING?

A SUSAR with seriousness criteria of life threatening and/or results in death must be reported within 7 calendar days. A SUSAR which if not life threatening or results in death must submitted to the regulatory authorities within 15 calendar days.
In addition to the regulatory authorities, a SUSAR may also need to be reported to other recipients including ethics committee and investigators.
As a Sponsor, you need to be fully versed in each change to the drug safety laws around SUSAR reporting as and when it happens. Including the changes you need to introduce to remain fully compliant. With the right support you can rapidly respond to the challenges in line with your Standard Operating Procedures.

PRE-MARKETING CLINICAL TRIAL PHASES

PrimeVigilance have considerable experience advising on the submission of ICSRs for clinical trial phases 1 -3. The focus will inevitably vary from trial to trial but it should be noted that any SUSAR is subject to extremely strict deadlines for submission. PrimeVigilance can advise on when, who and how to submit and when to insert information within a Development Risk Management Plan, the Development Safety Update Reports and End of Study Reports.

POST-MARKETING PHASES

Adverse reactions reported during clinical trials in the post marketing phase e.g. Post Authorisation Safety Studies (PASS) and all spontaneous reports will also need to be correctly expedited.

PrimeVigilance place particular emphasis on the timely reporting of SUSARs. With a fully validated E2B compliant safety database (ARISgTM), highly effective SOPs and operating guidelines, thorough employee training and a constant quality management system ‘on time’ reporting is a major priority. Reports may be made electronically or by hard copy as required by local regulations. PrimeVigilance can register and run electronic reporting systems such as EudraVigilance. EMEA trained employees to ensure compliance with the rigorous requirements’ of such a system.

PrimeVigilance – Compliant and Timely

– just one of the pharmacovigilance services from PrimeVigilance