A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP
 REGISTER
- To Register On-line: Click on the arow below, select the course date, and then click on Pay Now (securely processed by PayPal)
- To Register by FAX: download form (PDF)
|
Locations to choose from:
|
Contact Us :
Tel: +954-957-3957;
Fax: +954-366-6011;
E-mail:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
;
|
Early registration for the RESORT is $975 +tax, if paid in full 30 days or more before the start, after that is $1250 + tax.
Early registration for the CRUISE is $1350 +tax, if paid in full 75 days or more before the start, after that is $1550 + tax. |
To Register On-line:
Click on the arow below, select the course date, and then click on Pay Now (securely processed by PayPal)
Course Overview:
The Good Clinical Practices program provides the participant with a comprehensive background in Good Clinical Practices, a guideline of the International Conference of Harmonization and the FDA/GCP requirements.
The 2 day course and hands on workshop allows the participant to understand the responsibilities of the clinical investigator, sponsor and institutional review boards (IRB) or ethics committees. A complete background analysis of requirements for medical research is presented with the analysis of the Declaration of Helsinki and the Belmont report.
The entire presentations are done with sample cases that are specific to the guidelines presented to assist the participant put into practice GCPs. An in depth review of FDA issued warning letters to clinical research stakeholders is analyzed to further enhance the concepts and regulatory responsibilities.
Course Agenda:
Day 1 – 8:30 AM to 12:00 AM
|
Day 1 – 1:00PM to 5:00 PM
|
Overview of Good Clinical Practices (GCP) and Clinical Trial Process.
|
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC):
Responsibilities, Composition, Functions, Operations, Procedures and Records. |
Introduction to GCP:
THE PRINCIPLES OF ICH GCP and THE CLINICAL TRIAL PROCESS. The Clinical Development Plan, phases I-IV, Clinical Trials, Monitoring Reporting and Submissions. Safety Studies. Efficacy studies. Phase IV and Pharmaco-economic studies. Monitoring aspect of a trial. |
INVESTIGATOR:
Investigator's Qualifications and Agreements, Adequate Resources, Medical Care of Trial Subjects, Communication with IRB/IEC, Compliance with Protocol, Investigational Product(s) , Randomization Procedures and Un-blinding , Informed Consent of Trial Subjects, Records and Reports, Progress Reports, Safety Reporting, Premature Termination or Suspension of a Trial, Final Report(s) by Investigator. |
SPONSOR:
Quality Assurance and Quality Control. Contract Research Organization (CRO). Medical Expertise. Trial Design. Trial Management, Data Handling, and Record Keeping. Investigator Selection. Allocation of Duties and Functions. Compensation to Subjects and Investigators. Financing. Notification/Submission to Regulatory Authority (ies). Confirmation of Review by IRB/IEC. Information on Investigational Product(s) .Manufacturing, Packaging, Labeling, and Coding Investigational Product(s). Supplying and Handling Investigational Product(s). Record Access. Safety Information. Adverse Drug Reaction Reporting. |
MONITORING PROCEDRUES FOR CLINICAL TRIALS:
Purpose, Selection and Qualifications of Monitors. Extent and Nature of Monitoring. Monitor's Responsibilities. Monitoring Procedures. Monitoring Report. |
Day 2 – 8:30 AM to 12:00 AM
|
Day 2 – 1:00PM to 5:00 PM
|
CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S):
General Information, Background Information. Trial Objectives and Purpose. Trial Design. Selection and Withdrawal of Subjects. Treatment of Subjects. Assessment of Efficacy. Assessment of Safety. Statistics. Direct Access to Source Data/Documents. Quality Control and Quality Assurance Procedures. Ethics. Data Handling and Record Keeping. Financing and Insurance. Publication Policy. Supplements. NSR studies vs. SR studies. |
SAMPLE DOCUMENTS:
-Monitoring forms
-Auditing forms
-Standard Operational Procedures
-Case Report Forms
-Clinical Trial Documents
-Investigator Binder/file
-Trial Master Files |
INVESTIGATOR'S BROCHURE:
Introduction. General Considerations. Title Page. Confidentiality Statement. Contents of the Investigator's Brochure .Table of Contents. Summary. Introduction. Physical, Chemical, and Pharmaceutical Properties and Formulation. Non-clinical Studies. Effects in Humans. Summary of Data and Guidance for the Investigator. |
SOP WRITING:
-Essentials on writing Standard Operational Procedures for Clinical Research |
ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL:
Introduction. Before the Clinical Phase of the Trial Commences. During the Clinical Conduct of the Trial. After Completion or Termination of the Trial. |
THE AUDIT PROCESS, AUDITABLE DOCUMENTS, FDA AND HEALTH CANADA AUDITS:
Purpose. Selection and Qualification of Auditors. Auditing Procedures. Noncompliance. Premature Termination or Suspension of a Trial. Clinical Trial/Study Reports .Multi-centre Trials. |
Who Should Attend
This two-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Medical Devices and allied industries with daily responsibilities in the following areas:
|
|
|
|
|
|
- Documentation and Medical Writing
|
|
- Others who interact together to launch a product
|
|
|
|
|
CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL
Upon Completion of the course:
- ***CME: 12 Elective credits by the American Academy of Family Physicians will be available to qualifying participants and
- All participants will receive a Certificate of Attendance
- Also, after completion of the course, participant may decide to take a comprehension exam. If the exam is passed successfully, participant will receive the Certificate of Completion (step 1 of CCRP Certification).
|
Registration fee for the RESORT includes:
- 2 whole days of training in a beautiful ocean-front hotel,steps to popular Las Olas Beach, in Fort Lauderdale, Florida
- Presentation, Reference and Study Materials( printed, also electronic copy)
- Breakfast, Luncheon and Refreshments
|
Registration fee for the CRUISE includes:
- 2 whole days of training on a luxury Friday to Monday All-Inclusive CRUISE
- Presentation, Reference and Study Materials( printed, also electronic copy)
- All meals and Refreshments
|
- Each participant will receive a copy of the book:
"Good Clinical Practice (GCP) Audit Preparation: A Guide for the Pharmaceutical Industry", by: dr Mihajlovic- Madzarevic, Vera (to be published in April 2010 - ISBN: 9780470248850-Wiley)
|
Not Included
|
|
- Transportation to/from the airport
|
|
|
- **Hotel accomodation: (Pelican Beach resort is completely non-smoking)
To reserve your room, call Amanda Mohler at Direct - 954.556-7560, Hotel-954.568.9431 or (800) 525-OCEAN and mention the "Clinical Research Institute of America's" special rate for the room (valid up to 1 month before course starts). You may also want to send an e-mail to:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
|
- Tax is not included, please add 6% to the price of the course.
|
Special group rates for this course (% off the regular price of the course):
- From 1-2 people from the same facility/clinic - as advertised
- From 3 and up to 5 - 10% discount for the entire group
- From 6 and up to 10 - 15% discount for the entire group
- More than 10 people per group - please call Vesna at 1-877-428-1427
Upon registration, you will receive a complete agenda and detailed information.
At the time of registration, please notify us of any special dietary requirements.
Enrolment to the course is accepted until one (1) week before the starting date.
Clinical Research Institute of America reserves the right to cancel the course, if insufficient number of students are enrolled.
For more information please Contact Us at:
Phone: 1-877-428-1427 (toll free USA & Canada) or +954-975-0860 Fax: 954-366-6011
E-mail:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
*CANCELLATION POLICY (% fee is based on a regular price of the course)
Cancellation from date of signing up to 30 days prior to event...........full refund
Cancellation from 30 days to 20 days prior to event.............................10% fee
Cancellation from 20 days to 10 days prior to event….. ……............. 20% fee, after that......... 30% fee
Note: Tax is not included - please add 6% to the price of the course.
PRIVACY POLICY
Any of the information we collect from you, in this form, will be used solely for the purpose of registering for this course. We do not sell, trade or otherwise transfer to outside parties any part of your personal information.
top page
|
Programs