B8:    International standardization to share pharmaceutical information : efforts of ICH (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)

Mihoko Okada PhD. Professor, Department of Medical Informatics. Kawasaki University of Medical Welfare (Japan), Robert E Hizer, Information Advisor in Clinical and Regulatory Systems. Eli Lilly and Company (USA), Esteban Gonzalez Juarros, Principal Administrator at the Pharmaceuticals and Cosmetics Unit of the European Commission (Belgium), Karel de Neef, European Agency for the Evaluation of Medicinal Products (EMEA) (UK)

Target level: BEGINNERS

It is now a common matter of concern for many organizations how to represent and process pharmaceutical information electronically in such a way that it can be shared among different organizations within a region or among different regions of the world. To make pharmaceutical information sharable, standards are of critical concern. There exist various standard development initiatives around the world including the activities of ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). ICH is a project that brings together the regulatory authorities of Europe, the US and Japan and experts from the pharmaceutical industry in the three regions to discuss scientific and technical issues of pharmaceutical product registration. The session, consisting of the following, will focus on the latest developments of ICH electronic standards for pharmaceutical regulatory information.

• "ICH standards for the Transfer of Individual Case Safety Reports - impact on the US industry and regulatory authorities" Robert E. Hizer, Eli Lilly and Company
• "Electronic Exchange and Management of Pharmacovigilance Information in EU" Esteban Gonzalez Juarros, European Commission
• "Electronic Product Information Management (PIM) in the EU" Karel de Neef MD PhD. European Agency for the Evaluation of Medicinal Products (EMEA)

All speakers are active members of the ICH Electronic Standards Expert Working Group, and the steps regulatory authority and industry leaders of the world are taking towards developing standards and implementing organizational and/or regional databases of pharmaceutical information will be presented. The first two presentations are about the individual case safety reports, one of the major topics of ICH electronic standards. Although there are a number of research papers on databases in academia, there are few examples of their implementation of practical use. Based on the strong scientific background in Computer Science and Engineering, both of the lectures will discuss pharmaceutical information management from a practical point of view derived from many years of experience.

Electronic submission to regulatory authorities is another area where ICH is taking an initiative to establish global standards. Dr Karel de Neef, the third speaker, will present an example of one such standard - the Electronic Product Information Management (PIM) project in the EU, a joint effort of EMEA, Member States and EFPIA. The project provides a dramatic simplification of the management of Product Information while improving quality of information and providing the possibility of instantaneous updates of e.g. the package leaflet in all relevant languages (currently 13).

The tutorial will be participatory and practical. The delegates will obtain a copy of slide files and/or other handouts. The session will be structured to allow ample time for the delegates to discuss with the lectures about the implications of the international electronic standards from an implementation perspective, and to evaluate the usefulness of the standards for specific needs.