Nicosia (Cyprus), May 16th - 18th, 2012
Cleopatra Hotel - Workshop on GCP & Investigator Meeting DEEP1/DEEP3
The meeting in Cyprus will be held with adouble purpose: to train partner on GCP in paediatric clinical trial and to geteveryone acquainted with the final protocols of DEEP-1 and DEEP-3 studies andabout the trial related procedures.
In particular, the training workshop isaimed at ensuring compliance of the GCP according to EU Directive 2001/20/EC,and the EU Directive 2005/28/EC.
Particular attention will be paid to countriesoutside the European Community to ensure that standardised rules, compliant tothe Directive 2001/20/EC, are followed.
During the Investigator Meeting, all subject involved (Investiagators, CRO, Pharmacovigilance Team) will havethe opportunity to meet and interact.
Some of the activities that will bediscussed during this meeting are:
- Study visits and randomization procedures
- CRF
- Sponsor/Investigator responsibilities
- Informed Consent process
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Castelvolturno (italy), February 13th - 14th, 2012
Holiday Inn Naples - meeting
The training workshop is aimed at increasing the awareness of ethical issues related to paediatric research in the framework of a multicentre study including EU and non‐EU countries. In this context, empowering the role of parents in decision process defending rights, safety and well‐being of children involved in clinical research, is one of the main objective of DEEP. Finally, the workshop is aimed at finalizing the documents to be submitted to the competent bodies (Ethics Committees and competent Authorities).
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