ICH recently agreed to use the International Organization for Standardization (ISO) ICSR standard to meet the reporting requirements for E2B(R3).
Horsham, PA (PRWEB) March 09, 2012
DIA, in collaboration with FDA, is organizing back-to-back FDA Information Days in Silver Spring, MD. FDA Information Day: Individual Case Safety Reports (ICSR), held March 13-14, will explore the progress made in developing a new ICSR format by the International Conference on Harmonization (ICH) in collaboration with Standards Development Organizations.
FDA Information Day: Identification of Medicinal Products (IDMP), held March 14-15, will focus on the IDMP standards, which were developed in response to a worldwide demand for internationally harmonized specifications for exchanging medicinal product information in a robust and reliable manner. The IDMP standards support the regulation of medicines and pharmacovigilance including ICSR.
Session topics will include:
- The ongoing international standardization work on ICSR and IDMP
- New features of the ICSR and IDMP standards
- Implementation of new ICSR and IDMP standards for adaptation in pharmacovigilance systems
“ICH recently agreed to use the International Organization for Standardization (ISO) ICSR standard to meet the reporting requirements for E2B(R3). ICH defines the way that this standard should be used by means of the ICH Implementation Guide (IG), which covers the use of the fields defined by the E2B(R3),” said Program Chair Vada Perkins, MSc, BSN, RN, Regulatory Program Management Officer, Office of the Director, CBER, FDA. “The ICH Implementation Guide has been further developed and reached Step 2 in June 2011. This guide has been released for ICH Step 3 public consultation.”
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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 medical 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. http://www.diahome.org.