GOOD CLINICAL PRACTICE - Professional courses: How to write a clinical research protocol for a successful project
15/03/2021 13:00 to 15/03/2021 19:00 (Europe/Luxembourg)
Performance of clinical trials according to Good Clinical Practice (GCP) principles has been introduced as a European regulatory requirement by the Clinical Trial Directive 2001/20/EC. Strict adherence to this standard ensures patient protection and reliable data. It is the basis for acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.
The Clinical and Epidemiological Investigation Center is organizing an advanced Good Clinical Practice Training. The training is highly recommended to all persons involved in research projects with human participants.
In this interactive workshop current experience and requirements of GCP-conform set-up and performance of clinical trials will be presented, their practical implications and examples discussed and pragmatic solutions for your daily practice elaborated.
This online training will be held in English.
Important note:
Certificate is valid for 2 years. It must therefore be renewed to comply with good clinical practices.
PROGRAMME
13:00 | Welcome and introduction
13:10 | Good Clinical (Research) Practice in European Legislation
14:10 | Question & Answers
14:20 | Break
14:35 | Set up of a clinical trial at the investigative site
15:00 | Discussion
15:10 | Optimizing the inform consent process
15:35 | Discussion
15:40 | Break
15:50 | GCP compliance in document management
16:25 | Discussion
16:30 | Break
16:45 | Critical elements of conducting clinical trials
17:30 | Discussion
17:35 | Break
17:45 | Reliable safety management at the site
19:00 | End of the training
SPEAKER
Ingrid Klingmann
MD, PhD, FFPM, FBCPM
Expert in Drug Development Planning and Site Management Support, Pharmaplex bv, Brussels, Belgium & Chairman of the Board of European Forum for Good Clinical Practice (EFGCP)
Language: English
INFORMATION
When: 15th March 2021
Time: 1:00 p.m. – 7:00 p.m.
WEBINAR VIA WEBEX
REGISTRATION
As the number of seats is limited, we will accept registrations on a first come first served basis.
| | Fees | |
| 1st price category | LIH / IBBL Students / UNI / LCSB National hospitals national health care professionals researchers / PI national academia | € 0 |
| 2nd price category | International academia | € 100 |
| 3rd price category | Industry / private companies | € 200 |
