EMA pharmacovigilance training materials

The European medicines regulatory network has developed open access training materials, guidance, tools and templates to strengthen national pharmacovigilance systems and support Member States in the implementation of best practice. These materials are publicly available and can be useful for marketing authorisation holders, healthcare professionals, patient and consumer organisations and academia.

Training include below topics:
1 Collection of adverse drug reactions: These training materials focus on national schemes for the spontaneous reporting of adverse drug reactions (ADRs) by healthcare professionals and patients. They aim to provide national competent authorities (NCAs) with a better understanding of available systems and practices for collecting ADRs.


2. Signal management: These training materials seek to further improve understanding of signal management within the European medicines regulatory network and develop best practice in signal management.


3. Risk communication: These training materials focus on risk communication practices in the EU medicines regulatory network, including the various communication channels and tools used and the effectiveness of different strategies and methods.


4. Quality management systems: These training materials aim to increase existing knowledge on quality management systems and to help develop tools to support quality standards and best practice in pharmacovigilance systems.


5. Life-cycle pharmacovigilance: These training materials explore the standards for pharmacovigilance assessments and examine the availability and use of data sources other than spontaneous reports in different national competent authorities.

Click below link to find Training materials:

https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance/pharmacovigilance-training-materials


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