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Drug Information Association, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA
2006-04-03
This program will address the latest status in the US and the EU regarding the electronic reporting initiatives from regulatory and industry perspectives. The special areas that will be covered in depth are:
• An overview of the current regulatory environment and future initiatives;
• The current achievements and the further developments of the Adverse Event Report System (AERS), the Vaccine Adverse Event Report System (VAERS), and the EudraVigilance System in view of supporting the pharmacovigilance activities and risk management initiatives from the perspective of FDA’s CDER and CBER as well as the EMEA;
• The industry perspective on the practical implementation aspects and operational concerns regarding the integration and use of the interdependent ICH E2B(M), M2, and M1 (MedDRA) guidelines and standards;
• The lessons learned based on practical examples; and
• The recent ICH initiatives with main focus on the revision of ICH E2B(M) guideline and the ICH M5 topic on data elements and standards for drug dictionaries related to core medicinal product information, as well as the ICH maintenance activities of controlled vocabularies.
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Organized by:
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Drug Information Association |
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Invited Speakers:
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William W. Gregory, PhD,
Roger A. Goetsch, RPh
Lise Stevens-Hawkins
Sabine Brosch, MSc
Kostas Kidos , MSc
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Deadline for Abstracts:
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NA
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Registration:
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Please contact Jolene McNeil at +1-215-293-5810 ,Fax +1-215-442-6199, Or Email: Jolene.McNeil@diahome.org
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E-mail:
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dia@diahome.org
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