GCP Audits in Biostatistics
What does the auditor look for? Get the answer in this seminar with real world audit insights from two experts.
- 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
Aims and objectivesBiostatistics 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.
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!
- Regulatory basics ICH E6 and ICH E9
- The role of the statistician in clinical research
- Background: Study statistician vs statistical programmer
- Duties and responsibilities
- Expected qualifications
- Audits as a quality-assurance measure in clinical trials
- Audits to verify data integrity
- Preparing, conducting and following up audits
- Differences between audits and inspections
11:00 Coffee break
- Clinical trial protocol and amendments
- Determining sample size
- Data monitoring committee
- Statistical analysis plan
- Creation of analytical programmes
- Interim analysis
- (Blind) data review meeting
- Unblinding and final analysis
- Statistical and clinical study reports
- Validation of computerised systemsThe following will be discussed for each of the above points:
- GCP-compliant implementation: What is expected?
- What does it really look like, during audits, for example?
- What needs to be documented?
- Relevant interfaces with other departmentsDuring the talk, there will be a coffee break at 16:00.
16:00 Coffee break
17:00 End of seminar
Rita Hattemer-Apostel has worked in clinical drug development since 1991 and in Quality Assurance since 1994, having successfully implemented and managed GCP QA departments. She is co-founder and since 2001 CEO of Verdandi AG, a Quality Management Consultancy supporting organizations in their quality management related to clinical trials. She has performed more than 650 audits worldwide in all areas and for all types of clinical trials. For 10 years, she was Editor-in-Chief of the ‘Quality Assurance Journal’ published by Wiley, UK, she was President of the Swiss Professional Association of Quality Assurance (SPAQA) for 6 years, and she contributed to Research Review Panels of the EU Commission. Rita Hattemer-Apostel has been a regular and invited speaker for GCP / QM topics at international conferences and seminars since about 20 years.
Nähere Informationen finden Sie hier.
Managing Director Martin Scott is a statistician with 20 years' experience in the pharmaceutical and medical device industries. He has worked for companies in the UK, Germany, Switzerland and Italy, and currently heads up the German office of Numerus, a statistical consultancy specialising in late phase development and reimbursement. His position in Germany allows him to follow the development of the European HTA authorities and the statistical methods required for a successful application for reimbursement. His other interests revolve around the use of observational trials for regulatory submissions, pharmacoepidemiology and the statistical methods performed therein.
Phone: +49 69 21930-0
Fax: +49 69 21930-599
Bilingual Speaker The course will be held in English, thus a good knowledge of the English language is required. Nevertheless it will also be possible to pose questions in German.
All GCP relevant statistical issues were presented and all questions were answered.