Speakers:

Simona Cimbro, Sr Manager Clinical Monitoring

Stefano Gregoriani, Sr Director Country Operations – Chiltern International

The following topics will be covered during the course:

General considerations
Ownership
Requirements for validity of information and consent
Mode of expression (written consent)
Consent in vulnerable patients
Minors
Incapable and psychiatric patients
Seniors
State of need and temporary incapacity
Practical guidelines for the drafting of the Information Sheet/Consent Form
Examples of Study Information Sheet/Consensus Form for Study
Child and FI/ICF consent
What the future holds for us in Clinical Trials
Group consent and vulnerable patients in the EU Regulation
Electronic consent (according to FDA)
Biotestament cd law

Audience Target: Training and updating for professionals working in the field of clinical research, in particular CRA, and/or Start up Specialist experts and/or naive who are interested in deepening the proposed topics.

Location: Chiltern International, Via Montecuccoli n. 20 – Milan

Timetable: 10:00 -13:00 and 14:00 -16:00

The registration fee due, per person, is € 100.00 (without VAT) for participants belonging to AICRO member companies and € 180.00 + VAT (total € 219.60) for non-members of AICRO.

It is possible to subscribe in the short courses by filling in and subscribing to the appropriate

Registration Form