From the early beginnings of IDMP, the reporting of adverse drug events through the ICSR standard format has been an important use case to significantly improve global pharmacovigilance. In this webinar the speakers will provide coding guidance and principles for the accurate and consistent representation of drug information (including vaccines) in the ICSR message, focusing on Medicinal Product Identifiers (MPIDs) and Pharmaceutical Product Identifiers (PhPIDs) (with or without name parts) that will result from the implementation of the IDMP standards. Links with other required terminologies, such as MedDRA, in the ICSR will also be discussed, both from a standards and a daily practice perspective.
When ? Friday 3 December 2021: 3.00 pm-0.4.30 pm CET
- Anja van Haren (WP 8 and CBG/MEB)
- Barry Hammond (WP 1 and MedDRA)
- Sarah Vaughn (MHRA)
- Julie James (WP 9 and Blue Waves Informatics)
- Jane Millar (WP 1 and SNOMED International)
The EMA Management Board has announced on 19 December 2019 that the use of the ISO ICSR format as set out in Article 26(2)(a) of the Commission Implementing Regulation (EU) No 520/2012, and the modalities on how to implement and apply the ISO ICSR standard as defined in the ICH E2B(R3) shall become mandatory as of 30 June 2022 in relation to reporting obligations to Eudra Vigilance.
Additionally, ICH E2B has agreed to use the ISO standard terminology on pharmaceutical dose forms and routes of administration as set out in Article 25(f)(1) of Commission Implementing Regulation (EU) No 520/2012. The standard terminology on pharmaceutical dose forms and routes of administration as maintained by the European Directorate for the Quality of Medicines & HealthCare (EDQM) shall become mandatory in EU as of 30 June 2022 in relation to reporting obligations to EudraVigilance. ICH defines the way that the ISO ICSR standard 27953-2:2011 should be used by means of the ICH E2B(R3) Implementation Guide (IG) which covers the use of the data elements defined by E2B(R3).
The ISO standard itself does contain additional data elements or requirements that are not used by ICH but may be used by specific regions. This guidance describes the additional EU specific requirements to generate a valid ICSR (also referred to as Safety Message) and Message Acknowledgment to implement EN ISO ICSR 27953-2:2011 in accordance with ICH E2B(R3). This guidance should be read in conjunction with the ICH E2B(R3) Implementation Guide and related materials published on the ICH website. This guidance also specifies the technical requirements and the process of transmission of Safety and Acknowledgement Messages through the EudraVigilance Gateway and describes the obligations that stakeholders have to adhere to in this process to assure a successful electronic communication. The Electronic Data Interchange (EDI) process is based on the electronic exchange of a Safety Message between a Sender and a Receiver. The Acknowledgement Message confirms the receipt and the outcome of the validation of a Safety Message and completes the EDI process.
With the exception of ISO 11240 (UCUM) which is already a fully integrated part of the ISO ICSR standard,the use of terminologies and identifiers resulting from the ISO IDMP standards was not included in the ICH E2B(R3) Implementation Guide. ICH published supplementary information on the use of terms for dosage forms and routes of administration as specified in the ISO standard 11239 for use in the electronic exchange of ICSRs according to the ICH E2B(R3) Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs). It specifies the use of terminology for pharmaceutical dose forms and routes of administration as published in the EDQM Standard Terms. Use of EDQM terms for Dosage forms and Routes of administration shall become mandatory as of 30 June 2022 in relation to reporting obligations to EudraVigilance