EDM and ERS/eCTD Tutorial 2: Get Ready for Global ISO IDMP, Including Lessons Learned from the EU XEVMPD
Oct 15 2013 8:00AM - Oct 15 2013 11:30AM | Town and Country Resort and Convention Center
500 Hotel Circle North
San Diego, CA 92108
The tower of Babel was never finished, because the builders did not speak the same language anymore; in other words they used different vocabularies. Within the pharmaceutical industry we also apply multiple vocabularies across the various disciplines. Across industries; regulatory bodies and healthcare professionals we use even more vocabularies. This negatively impacts the transparency of information related to an efficient production, risk-benefit evaluation and safe usage of medicinal products. Improved transparency will achieve better medicine and better usage of medicines. ISO established ways to identify medicinal products using standard terms; ISO IDMP. This is one of the ways to achieve a common vocabulary.
Please note that lunch is not served on tutorial day.
At the conclusion of this tutorial, participants should be able to:
- Describe why ISO IDMP impacts all R&D, RA and manufacturing departments within a pharmaceutical company; to obtain a common vocabulary
- Discuss what documents and databases from those departments are impacted
- Explain that companies need to start ASAP with setting up a common vocabulary
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.