Good Clinical Practice (GCP) Course for the Investigator. Practical and Hands-on Training for Site Staff

Transcription

1 Good Clinical Practice (GCP) Course for the Investigator Swissmedic certified for the Investigator Practical and Hands-on Training for Site Staff Venue: Netts Schützengarten Sankt Jakob-Strasse 35 CH 9000 St. Gallen Date: 22 November 2012 Time: 08:30 17:30

2 rosenbergstrasse 69, 9000 st.gallen, switzerland GOOD CLINICAL PRACTICE (GCP) FOR THE INVESTIGATOR Practical and Hands-on Training for Site Staff The requirements for conducting and managing clinical trials are increasing every year. We have combined our knowledge obtained over the last 25 years in the pharmaceutical industry with the most recent international and local information in clinical research and created a unique intensive 1 day course for the Investigator working on sponsored trials. Aim: To provide the Investigator with the GCP (ICH & ISO) principles needed to competently conduct and manage clinical trials. To provide the supporting site staff with an in-depth look into the clinical trial process and the ethical and legal issues affecting all site members on the international and local level. Target Audience: Investigators requiring GCP training Investigators that want to refresh their knowledge and skills Sub-Investigators, Study Nurses, Clinical Research Coordinators and other site staff involved in clinical research People interested in working in clinical research Program Details: ICH GCP: Principles, Clinical Trial Ethics ICH-GCP versus ISO Clinical Trial Design: Scientific Methodology, Trial Protocol, Investigator Brochure, CRFs Clinical Trial Process: Pre-Clinical Post-Marketing, Clinical Trial Planning Presentation / Publication Clinical Trial Management: Roles & Responsibilities of the Sponsor, Investigator, Ethics Committee, Health Authority, Monitor Trial Documentation: Trial Master File / Site Files, Source Documentation Informed Consent: from A to Z Safety: Definitions and Reporting requirements QC & QA: Auditor, Inspections, Findings Methods: We have created a hands-on practical course with many examples of real day to day issues the site will encounter. Group work, case studies and quizzes will be used to aid in the retention of information and to build on existing knowledge. Certificates and Accreditation: Swissmedic has certified this course which fulfills the published requirements accepted by Swissmedic, AGEK, SAMW, SMIFK, SIWF, SGCI and SCTO for the training of the Investigator. SwAPP / SGPM accredited 7 points

3 Course Details / Terms and Conditions: Time: 08:30-17:30 Date / Venue: See our cover page for details on the dates and venue location. Travel directions can be found on the last page. We can also come to you! Materials: Language: Each participant will receive the PowerPoint Presentations with all supporting documents and handouts in paper copy and on a USB stick. A complimentary ICH-GCP booklet is included. The course content and discussions will be held in English. German can also be used during the discussion only when all participants are fluent. Participants: We specialize in small group courses with a minimum of 10 and a maximum of 15 participants. Courses for less than 10 people are possible, but the rates below do not apply. Please contact us for more details. Fee: CHF plus 8% V.A.T. SwAPP members will receive a 10% reduction. Special arrangements can be made, please contact us for details! The fee includes all course materials, refreshments, snacks, lunch and a certificate of attendance. Registration: Please fill in the registration form and send it back to us by: info@schmidconsult.com Fax: Regular mail: Rosenbergstrasse 69 CH-9000, St. Gallen. Please note that registrations are done on a first come first serve basis and that your place is only reserved after full payment. You will receive a registration confirmation and an invoice by within 5 business days. Please contact us if you have not received this. Payments: The payment is due 1 month prior to the commencement of the scheduled course. After you make your payment, a receipt with registration confirmation will be sent to you by . Cancellation: Participants who cancel their enrolment 1 month before the scheduled commencement of the course will receive a full refund. Between 1 month and 14 days: 75 % refund Between 14 days and 7 days: 50 % refund 7 days or less: No refund Cancellations must be in writing; letters and s are acceptable.

4 Directions By Car from Zürich: Take the A1 to exit St. Gallen-Kreuzbleiche Follow exit Zentrum / Appenzell Keep left after the tunnel on Rosenbergstrasse Continue on Unterer Graben Turn left on Sankt Jakob-Strasse Number 35 is 200m on the left Parking spaces are available behind the building Public Transportation: From St. Gallen HB train station, take Bus no. 3 to St. Gallen-Schützengarten.

5 INTERNATIONAL CLINICAL RESEARCH rosenbergstrasse 69, 9000 st.gallen, switzerland GCP for the Investigator Single Registration Form I would like to apply for: Course Date Your details Mr. Mrs. Miss First name Title Company name Address Course location Last name Position Work Telephone Work Fax Work Is the address above the billing address? Yes No Billing details (if not the same as above) First name Address Last name Telephone Fax Are you a SwAPP member? Yes No If yes, please provide your membership number: By signing this form, I confirm that I have read the course details and agree with the terms and conditions Applicant signature Date Please fax your registration to or to info@schmidconsult.com GCP for the Investigator_Single Registration Form_V1_25May12 page 1 of 1