ג'י.סי.פי ניסויים קליניים

Two-Day Seminar
12-13 , Rosh Ha’Ayin, ISRAEL
This seminar is addressed to medical device company professionals involved in the planning, designing, managing, conducting and reporting of clinical studies
Clinical Project Managers

Clinical monitors
Regulatory affairs
Medical affairs
Sr Executives of start-ups

:Seminar description
Strategic planning and proper conduct of medical device clinical studies are not trivial matters. Effective study design and planning, thorough knowledge of international and national regulations and achievement of enrolment goals within given deadlines all are crucial to success. This course will provide an overview of clinical study requirements and best practices for conducting clinical studies in Europe, with an emphasis on practical tips and methods for successfully achieving business objectives.
:Program Outline
EU and Israeli regulatory framework for clinical studies
- EU: MDD Article 15, Annexes VIII and X; AIMDD Article 10, Annexes 6 and 7 new requirements according to revising Directive 2007/47/EC
- The EU regulatory pathway: the CE marking process
- Israel: MOH Guidelines for Clinical Trials in Human Subjects, 2006

:Good clinical practices for device studies
- Analysis of revised ISO 14155 DIS.2
- Comparison with current ISO 14155:2003 and ICH-GCPs
:Key aspects of device clinical research
Is a clinical study needed? The clinical evaluation process
Clinical plan and study design -
[Types of clinical studies [pilot, pivotal, post-marketing
:The journey from study design to clinical report
 Protocol development and site/country selection -
Successful patient enrolment -
Ethics Committee and Competent Authority submissions -
Hospital agreements -
Study monitoring -
Safety reporting, complaint handling -
 Clinical summary reports -
GCP Clinical Studies Offices, 22 Hamelacha ST. Rosh Ha'Ayin, Israel