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)

• All-Inclusive, CRUISE with 2days training and
• Beach RESORT in Fort Lauderdale, Florida

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 month 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.

***Choose SPECIAL: If you want to register for 2 consecutive courses: A005 (RESORT) and DMR01 (RESORT) and pay in full one month or more before the start.

Total cost=$1500+tax for both classes (RESORT)***

• Good Clinical Practices and FDA/ EU/ Health Canada Regulations concerning Clinical Trials

• FDA Investigators responsibilities

• IRB/ERB, Financial Disclosure (US), Patient Information and Consent forms and process, Drug Development Process

• Confidentiality, delegation of authority

• Clinical Trials Documents: the protocol, the consent form, the investigators brochure, the case report forms

• Electronic systems in clinical research

• Clinical Study Audit (internal, regulatory audit)

• Response to an FDA 483 and Warning letters

• Obligations under contract agreement vs. Ethics and Medical Practice

• The sponsor/investigator, IND application process

• Physicians

• Medical Specialists

• Surgeons

• Any other Medical Professional who plans to participate or presently runs Clinical Trials

Course AGENDA: Clinical Research for the Principal Investigator ( A005)

Day 1

Day 2

   8:30am

• Registration and Breakfast  

• Breakfast 

• Welcome and Introduction to the course and workshop.
• Drug and therapeutic product development.
• Clinical Trial Process.

• The Institutional Review Boards, Financial Disclosure 

• Declaration of Helsinki, Good Clinical Practices and FDA/ EU/ Health Canada Regulations concerning Clinical Trials

• Obligations under contract agreement vs. Ethics and Medical Practice.
• The Belmont Report

Coffee break

Coffee break

• Investigators responsibilities, FDA Investigators responsibilities (form 1572)
• Clinical Trials Documents

• Essential Documents for the conduct of a Clinical Trial.
• Site documentation and archiving.
• Sponsors monitoring

LUNCH BREAK

LUNCH BREAK

• The Consent Process

• The Clinical Trial Site Audit Process, Auditable Documents, FDA/Health Canada Audit Strategies.

• Delegation of responsibilities at the Clinical Trial site

• Response to an FDA 483 and Warning letters (review of warning letters and responses)

Coffee break

Coffee break

• Investigational Product Accountability

• The Sponsor/Investigator, IND application process

• Q & A

• Qualifying exam*

*This test is mandatory for participants applying to the Physician Investigator Certification Program

• End of Day 1

• End of the program

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)

• Airfare

• Transportation to/from the airport

• Parking, tips...

• **Hotel accomodation: (Pelican Beach resort is completely non-smoking)

• Tax is not included, please add 6% to the price of the course.