A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP
 REGISTER
- To Register On-line: select the course date below, then click on Pay Now (securely processed by PayPal
- To Register by FAX: download form (PDF)
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Locations to choose from:
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Contact Us :
Tel: +954-957-3957;
Fax: +954-366-6011;
E-mail:
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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:
This intensive 2 day course and workshop is designed to provide the participant with an insight in the world of Pharmaceutical Research and Development. Graduates from scientific and health related disciplines will learn the main points of Drug development and the pharmaceutical industry, regulatory requirements for clinical research (FDA), and Good Clinical Practices as an international guideline for clinical research. The course will provide also with the basis of the responsibilities the sponsor, medical investigator and institutional review boards have when involved in clinical research. The participant will also learn to differentiate medical practice, experimental medicine and clinical research and the regulatory frameworks. The patient information and consent process and documents will be thoroughly examined as well as the clinical trial documents: the protocols, investigators brochures and case report forms. The main new technologies that assist clinical trials will be discussed as well as inspectional strategies for clinical trials.
Course Outline
- Pharmaceutical Product Development
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- Safety reporting, serious adverse events, classification, SAE forms, Clinical Labs
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- Medical device development
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- The Investigator site, coordinating clinical trials
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- Development of Biotech Products and Vaccines
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- The Sponsors Trial Master Files
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- Principles of Pharmacology
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- Patient Information and Consent process
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- Phases in Clinical Research
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- Monitoring clinical trials
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- FDA regulatory requirements for Clinical Trials (21 CFR 312, 50, 54, and 812)
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- Good Clinical Practices (GCP/ICH)
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- Standard Operational Procedures in Clinical Research
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Who Should Attend
This is a must attend course for all professionals who wishes to start a career in the following areas:
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- Documentation and Medical Writing
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- Others who interact together to launch a product
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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.
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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
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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
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- 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)
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Not Included
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- Transportation to/from the airport
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- **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:
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- Tax is not included, please add 6% to the price of the course.
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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:
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*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.
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