Date: 19 March 2018
Duration: 1 Day
Location: Amsterdam area, The Netherlands
Costs: Regular € 600.-
Early bird € 500.- (until 22 January)
Clinical operations professionals sharing practical experiences.
We will discuss all the ins and outs of the ISO 14155 standard during this hands-on training.
Besides the theory, we will go into detail about how to implement good clinical practices, the hurdles you might need to overcome, common site issues and their point of view. How do you, as a sponsor, can contribute to a smooth, efficient and compliant clinical trial?
We will share examples and experiences to provide best practice solutions. Your input during this training is very welcome!
Who should attend:
Clinical managers, CRAs, CTA's, RA managers, vigilance/ safety managers etc.
Everyone that comes across ISO14155 in their daily job and would like to get to know more.
09:15 - 09:30 Welcome with Coffee
09:30 - 10:15 Introduction
Regulation in Clinical Investigation
Requirements under the new MDR
Where do trials and ISO 14155 fit in the new regulations
10:15 -11:15 ISO 14155 - the content of good clinical practice standard
11:15 -12:00 Stakeholders in clinical investigations, puzzling all pieces together
(Manufacturer; QA, RA, Clinical Site; investigator, staff and patient).
How can your CRO support you?
12:00- 12:45 Good Clinical Practice in practice (a site perspective)
12:45- 13:30 Lunch
12:30- 14:15 Training - examples of not so good clinical practice. How to avoid pitfalls.
Interactive session. Bring your examples and experiences to the table.
14:15- 15:15 Training assessment in groups, "practicing"
15:15- 16:00 Discussing examples and ideas
16:00- 16:30 Wrap up