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PROOF OF CONCEPT TRIALS

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ARENSIA delivers high degree of scientific and logistical expertise for Phase I/Ib/IIa and PROOF OF CONCEPT patient studies.

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PHASE I SPECIAL POPULATIONS

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ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired patients.

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ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

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ICH GCP Training, May 30th/31st, Bucharest, Romania

HOME · NEWS · ICH GCP TRAINING, MAY 30TH/31ST, BUCHAREST, ROMANIA

Dear Health Care Professionals, Dear Colleagues,

With great pleasure ARENSIA Exploratory Medicine invites you to attend our annual ICH-GCP training* session on 30th/31st of May 2019 at INTERCONTINENTAL HOTEL in Bucharest, Romania.

Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. It is a standard within clinical research business to hold an up-to-date GCP certificate. The training offers the opportunity to refresh your GCP knowledge and provide
you an update on current changes in EU legislation and related guidelines.

Following topics will be discussed:

• History of GCP (USA and Europe)
• Definition of Clinical Trial, Investigator, Subinvestigator, Sponsor
• The Principles of ICH-GCP
• Introducing new section “Quality Management” into ICH-GCP (section 5.0)
• Ethics
• Responsibilities of Sponsor (transfer to CRO) + Investigator
• Monitoring

For registrations please contact us at+40 725 200 692 or via email at We are looking forward to a very informative training! See you in Bucharest!

* Participation fee 250 RON, including coffe and lunch breaks (VAT Included). 10% discount for groups of more than three participants from the same company.

Download the detailed agenda

30.05.2019