Date: 29 January 2018
Duration: 1 Day
Location: Amsterdam area, The Netherlands
Costs: € 600.- (Early bird €500.- until 1 december)
Clinical operations professionals sharing practical experiences. A hands-on training.
We will discuss all ins and outs of the ISO 141155 standard. 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 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 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.
9:15 - 9:30 Welcome with Coffee
9:30 - 10:15 Introduction
Regulation in Clinical Investigation
Requirements under the new MDR
Where do trials and ISO14155 fit in the new regulations
10:15 -11:15 ISO14155 - 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