Drug Information Association, FDA and European Medicines Evaluation Agency Discuss the ICH Guideline for Clinical Safety Data Management

April 19, 2011 |

2 min read

HORSHAM, PA, USA—APRIL 19, 2011—DIA, in collaboration with US FDA and EMA will host FDA Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B from May 12-13 in Alexandria, VA. In May 2005, the revised ICH Guideline for Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) (E2B(R3)) was released for public consultation. TheICH Steering Committee decided that technical specifications shouldno longer be developed solely within ICH, but should be created incollaboration with Standards Development Organisations (SDOs) toenable wider interoperability across the regulatory and health carecommunities. The ICSR is the fi rst topic to go through this process. ICHrepresentatives have been heavily involved in this initiative in additionto other experts from beyond the ICH community. The overall standardis based upon the HL7 ICSR model thatis capable of supporting a widerange of product types (e.g. human medicinal products, veterinaryproducts, medical devices, etc.).

This day and a half workshop will explore how a single, common standard for the ICSR could be advanced. Session topics include:

- Status of International Standardization of Clinical Safety Data Management

- Current ICH E2B(R2) Guideline and the HL7 Message Specifi cations

- How to Adapt the New ICSR Standard to Your Pharmacovigilance Systems

“ICH will define the way the new standard should be used by the publication of an ICH Implementation Guide, which will define the use of the data elements as outlined in the E2B(R3) guideline,” says Gaby L. Danan,GLD Conseil, Pharmacovigilance Expert and member of the program committee.“In addition, a harmonized approach to ensure backwards and forwards compatibility between the current ICH ICSR message specifications and the new standard – a major aspect during the transition phase until all stakeholders have upgraded their pharmacovigilance systems – will be addressed in the Implementation Guide.”

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DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China. For more information visit: www.diahome.org

Food and Drug Administration (FDA)