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How to Write an ICH-Compliant Clinical Study Report
This Clinical Study Report webinar/training is designed to provide guidance for producing such a document, included are the outline format, concepts, guidance for text, and guidance for the appendices.
Description
Clinical Study Reports (CSR) submitted to regulatory bodies in the drug development process must meet high quality scientific standards and be compliant with International Conference on Harmonization (ICH) standards. This webinar is designed to provide guidance for producing such a document. Included are the outline format, concepts, guidance for text, and guidance for the appendices.
Areas Covered in the seminar:
- Advice about BS, ethics, scientific interpretation, the expertise of regulatory bodies, and the problem of multiple writers.
- What is ICH; ICH guidance, a template.
- Synopsis and abbreviations.
- Introduction, ethics, and administrative sections,Objectives and administrative plan.
- Subjects, data sets, and baseline data, In-text tables and repetitiveness.
- Efficacy results, Pharmacokinetic results, other results & Safety results.
- Discussion/Conclusion.
- Appendices.
Who will benefit:
- Writers who want to become regulatory submission writers in the pharmaceutical or device industry
- Medical writers with a little experience in regulatory writing and who want to improve
- Medical (MD, PharmD) experts who write sections of CSRs
- Regulatory experts who want to enhance their ability to review and approve draft CSRs
Instructor Profile:
Robert S Hoop, MPH, is the owner and president of Robert S Hoop, Inc., a pharmaceutical consulting corporation in the San Francisco Bay Area. Hoop has specialized in the pharmaceutical clinical trial business since 1982 having previously worked for 3 international pharmaceutical companies and one international CRO. He has authored 6 peer-reviewed manuscripts and made presentations at 10 professional conferences. He has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials. Hoop has been given multiple awards for the quality of his oral presentations.
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