Clinical Trials in Portugal, Spain and Italy

What are the special characteristics of Clinical Trials in Portugal, Spain and Italy? Interview with Dr. Andreas Grund and Alfonso García.

0:27 Few words about Alfonso García and his experience in clinical studies.
1:54: General information about 3 countries, Spain, Italy and Portugal.
4:28: What kind of investigators are involved in these countries within clinical studies?
5:57: How much experience do the investigators have with clinical trials? Any legal requirement for GCP training courses or even refresher courses?
7:37: In terms of therapeutic areas, which kind of studies do you usually conduct in these countries?
9:20: About the regulatory system in those countries. How do the ethics committees work? What kind of competent authorities need to approve the studies in Spain, Italy and Portugal?
13:42: What do the sponsors need to expect in your countries regarding contract negotiation? Is it possible to speed-up the process if you know the rules?
16:34: What is your experience with local inspections in South Europe?
18:03: What will change in your countries with the new rules for Medical device studies?
19:32: How are the rules for Post market studies with CE marked medical devices in your Spain, Italy and Portugal?
22:55: Which southern European country would you recommend for conducting for Clinical Trials?
23:41: Any final recommendation?

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