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Seminar GCP Audits in Biostatistics
Biostatistics: What does
the auditor look for?
Real world audit insights from two experts
2019-06-07 2019-06-07 Fleming's Hotel Frankfurt Main-Riverside Lange Str. 5-9 60311 Frankfurt +49 69 21930-0 +49 69 21930-599

GCP Audits in Biostatistics

What does the auditor look for? Get the answer in this seminar with real world audit insights from two experts.

This semiars informs you what to focus on to be well prepared for your next GCP audit in Biostatstics.
  • GCP requirements and regulatory basics
  • GCP audits in clinical trials: Essential workflow information
  • Duties of the statistician during a clinical trial
  • Audits to verify data integrity: What does the auditor look for?
  • Biostatistics during a clinical trial: What is relevant in an audit?

This distinguishes our event

Overall impression: 100 % of the participants' feedback was very good or good (June 2018)
Course content: 100 % of the participants' feedback was very good or good (June 2018)
Practical benefit: 100 % of the participants' feedback was very good or good (June 2018)

Aims and objectives

Biostatistics is a central element in clinical trials and consequently in audits. What are the duties and responsibilities of statisticians? Where does their work need to be visible and transparent? What do auditors look for?
This seminar provides you with the answers to these and other questions concerning statistics in clinical trials. Our experts will always provide practical information, due to their in-depth audit expertise. The course will be held in English, nevertheless both speakers are bilingual and it will also be possible to pose questions in German.
Subsequently, you will be more confident the next time you prepare for an audit, you will know what to look for and how to be GCP compliant.
Who should attend
Are you responsible for planning and conducting clinical trials and want to be well prepared for your next GCP audit?
Are you an auditor and want to know your responsibilities concerning the statistical aspects of clinical trials? Do you want to learn about the major issues and what to look out for?
Then this seminar is for you!
Your speakers
Rita Hattemer-Apostel
Verdandi AG, Zürich

Martin Scott
Numerus GmbH, Tübingen, Germany

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IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards. An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018) produced a result of 1.6 (based on a school grading system of 1-6).