WRITING A COMPLIANT AND EFFECTIVE CLINICAL STUDY REPORT
The Clinical Study Reports (CSRs) are the critical documents by which regulators can assess the outcome of clinical studies. CSRs also include Clinical Trial Reports – the new EU terminology for CSRs when the study report pertains to an interventional (rather than non-interventional) trial.
CSRs are scientific documents addressing efficacy and safety, not a sales or marketing tool. But the sponsoring company’s goal is to sell a drug, biologic, or device. Sponsors want to showcase a product and the problem it solves, and they want regulators to focus on the forest, not the trees, to weave key messages with important study findings that are repeated throughout the marketing application. In the CSRs, key messages are found in the synopsis at the beginning and are reiterated in the body of the document as topic sentences, in summaries of sections or subsections, and in the conclusions. Sponsors hone key messages thoughtfully, selecting words and ideas to convey desired nuances. Although study findings determine key messages, messages may be influenced by other factors such as results of prior studies and characteristics of competing products.
CSRs for submission to the Health Authorities are also required to be in compliance with the International Conference on Harmonization (ICH) standards and must meet high quality standards.
Date: 16 September 2019
Time: 09:00 am – 6:00 pm
Venue: Hotel Melià, Milano, Italy
Cost: Early bird: € 750* (until 02-09-2019)
Ordinary: € 860*
Freelance – Academy – Public Administration: € 460*
* For Italian companies: + 22% VAT
The fee includes: tuition, teaching materials, lunches and coffee breaks, office assistance, attendance certificate
Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.
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