DEEP-2 Investigator Meeting

admin — Sun, 14 Aug 2016 05:56:28 +0000

The last DEEP-2 Investigator Meeting was organised on April 14th 2016 in the framework of the 7th DEEP General Assembly in Padua. It was designed as a guided roundtable where CRAs and Principal Investigators from main recruiting sites had the opportunity to depict the situation at their own centre (based on the PPT Model sent out to PIs by email) and identify the main issues faced during the study. The discussion was leaded by the Trial Management Team (D. Bonifazi, B. Pantaleo, B. Tempesta), the Coordinating Investigator (A. Maggio), the Quality Assurance (S. Morgagni) and the Qualified Person for PharmacoVigilance (M. Felisi).

In particular, CRAs and PIs highlighted the strengths and weaknesses encountered in the study conduction with particular reference to the following issues:

• Informed consent procedure

• Planning study visits

• IMPs handling

• Dose adjustments for Safety and Efficacy reasons

• Periodic assessments for Safety

• Data entry in e-CRF

• Collection of Ferritin Samples for centralized evaluations and MRI Scans

• Study documentation

• Pharmacovigilance

• Monitoring activities.

The gathered information have provided updated information on all the centres involved in the study and are essential to identify the main issues to be solved to increase the effectiveness of the study and to ensure patients’ safety and high quality of collected data.

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DEEP Open Meeting: Networking and Innovation for local development

admin — Wed, 13 May 2015 16:37:47 +0000

The Deep Open Meeting will be held in Tirana at the Hotel Tirana International on May 18th, 2015 with the participation of international prominent personalities in the field of clinical research.

It is promoted by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with University Hospital Center “Mother Teresa” (UHCT) and is organised in the framework of the DEEP project.

The Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research in Albania and the importance of the European Networks to create synergies to spread excellence and attract European funding and entails two thematic sessions:

1.Clinical Research in Albania

2.Networks and Projects in a global context

The Meeting is accredited by QKEV and provides with 5 CME credits for Continuing education for healthcare professionals.

All sessions will be in English but simultaneous Translation English /Albanian will be available.

The Open Meeting is foreseen in the framework of the 6th DEEP General Assembly that will take place from the 18th to the 20th of May, 2015 with the participation of the whole DEEP Consortium as well as of external experts. The General Assembly will also host the fourth Ethics Board meeting and the DEEP-2 Investigators’ Meeting, where a specific CRAs’ training session and individual training sessions on GCP, e-CRF and drug management will be available.

More details on the event and the related agenda are available here.

The post DEEP Open Meeting: Networking and Innovation for local development first appeared on DEEP Project.

meeting | DEEP Project

DEEP-2 Investigator Meeting

DEEP Open Meeting: Networking and Innovation for local development