PRAC Oral Explanation or Public Hearing  

Kinesys Regulatory Advisory Board can provide our international team of experts to support your planning for an OE at PRAC.

The Pharmacovigilance Risk Assessment Committee (PRAC) is the EMA’s committee responsible for assessing and monitoring the safety of human medicines. The PRAC provides recommendations regarding pharmacovigilance and risk management systems, including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.

The PRAC provides recommendations for centralised and non-centralised approved products. The PRAC may request an OE in connection with an evaluation procedure. The OE should be based on the data submitted in advance and assessed by the Rapporteur.

Additionally, the PRAC may hold Public Hearings, where it considers that this is justified particularly with regard to the extent and seriousness of the safety concern.

Kinesys Regulatory Advisory Board Assistance

Similar to a CHMP OE, EMA Solutions can provide our international team of experts to support your planning for an OE or Public Hearing at PRAC. This includes all medical/scientific aspects and communication strategy and will usually include a mock session in which our experts adopt the role of the PRAC and question the sponsor team on their proposed responses to issues.