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PTF7 14:00 Friday
Barcelona
Professional Techniques
Under Assessment (Foundation)
Document Review: Review Processes and Technical Aspects
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Volker Peinke
Bayer Schering Pharma AG


Participant profile
The workshop is intended for medical writers who are involved in review processes. Although those medical writers who are organisers of the review process will have the greatest benefit any other party involved will benefit by understanding the complexity of the review and by learning how review processes can be better organised. Basically participants should have been involved in several reviews of documents.

Objective
The workshop will enable participants to understand the complexity of the review process and to identify the critical issues related to the review of documents. It is the aim of the workshop to provide rules and techniques to improve the review process and also to avoid unnecessary review cycles. Examples will refer to the clinical study report but apply to all kinds of documents including publications.

Content
The participants will identify major flaws of the review process. They will learn about review styles and how the styles translate into appropriate information that will need to be communicated to reviewers. Technical aspects of documenting and archiving the review results will be presented as well as techniques to improve the quality of review meetings. Participants are encouraged to use their computers during technical demonstrations (Software MS Word for Windows XP and if available Acrobat Writer Version 7). Finally, there will be a short summary as take home message.

Pre-workshop assignment: 01:00 hour
Post-workshop assignment: 01:00 hour