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ADVERSE EVENT REPORTING GUIDELINES Updated: July 2023EPHMRA ADVERSE EVENT REPORTING (AER) GUIDELINES REVISED JUNE 2023 The EPHMRA AER Guidelines have been written for Marketing Authorisation Holders
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01
Gather all necessary information related to the adverse event.
02
Identify the EPHMRA code that corresponds to the specific adverse event.
03
Fill out the EPHMRA market research adverse form accurately and completely.
04
Provide any additional details or comments that may help in understanding the adverse event.
05
Submit the filled out form to the appropriate department or individual for review and analysis.

Who needs ephmra market research adverse?

01
Pharmaceutical companies conducting market research on adverse events.
02
Healthcare providers looking to track and report adverse events for regulatory purposes.
03
Regulatory agencies monitoring the safety and efficacy of medications in the market.
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EphMRA stands for European Pharmaceutical Market Research Association. Adverse events refer to any untoward medical occurrence associated with the use of a pharmaceutical product.
Pharmaceutical companies and other stakeholders involved in market research activities are required to file ephmra market research adverse reports.
The ephmra market research adverse report can typically be filled out online through a designated reporting system provided by the regulatory authorities.
The purpose of ephmra market research adverse reporting is to monitor and ensure the safety and efficacy of pharmaceutical products in the market.
The information to be reported on ephmra market research adverse includes details of the adverse event, patient demographics, type of product involved, severity of the event, and any actions taken.
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