
	What is CADDY? CADDY-xml CADDY History CADDY Forum Electronic Submission Expert Group Information Brochure Format Specification Application Guide Conformity Test Guidelines Developers Page CADDY eReview Workshop

CADDY eReview Workshop 17-18 November 2003

Goal of the Workshop

To consider the potential use of CADDY as an evaluation and work sharing tool to support the regulatory process.

It was intended that the workshop will allow participants:

to understand functionality of the new version of CADDY
to consider its potential use within their regulatory authority
to explore fully the potential use of CADDY to support the 91/414/EEC process

What was covered in the workshop

CADDY has provided an effective solution to the problems of dossier storage and handling. The workshop brought together Member States, accession countries, the Commission, EFSA and industry to consider the potential use of CADDY as an evaluation and work sharing tool to support the regulatory process.

Topics The presentations shown at the eReview workshop can be viewed by clicking on the links in the table. Pdf files can be read using the Acrobat Reader (download).
Introduction
Overview of CADDY 2.0 (1,08 MB)	Plenary session - presentation.
System requirements for CADDY (452 KB)	Hardware requirements. Ergonomics. Operating systems, stand-alone use vs. workgroup use (networks). Installation and administration issues. Dossier registration.
Receipt and handling of CADDY dossiers (293 KB)	Receipt and handling in relation to system issues (stand-alone use vs. network use). Conformity testing. Completeness checking. CADDY version control.
Potential use in DAR preparation (2,28 MB)	Use in evaluation. Use of annotations/hyperlinks to exchange information with the notifier. Use of structured summary files. Use in RMS/Co-RMS process. Production of DAR with hyperlinks to the dossier.
Potential use in DAR peer review and the decision making process (647 KB)	Accessing underlying studies electronically during peer review. Exchange of information using CADDY. Use of links in reporting tables, evaluation tables and MS comment letters. Use of CADDY dossiers by Scientific Panels.
Post inclusion activities – CADDY to support product re-registration and long term archiving (135 KB)	Archiving issues. Post inclusion compliance using CADDY submission. Use of CADDY to support product re-registration.
Discussion and conclusions	Closing plenary session.


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