Ministry of Health

GCP is an international ethical and scientific quality standard set for monitoring, designing, conducting, recording, analyzing and reporting clinical trials involved human subject. The adherence to the mentioned standards is obligatory for all clinical trials to be carried out in UAE. At the same time clinical trials submitted within different applications at Drug Control Department at Ministry Of Health-UAE would not be accepted if any incompliance for the given standards is proved (Guidance for conducting Clinical Trials Based on Drugs/ Medical Products & Good Clinical Practice, MOH UAE).

Definition:

"Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects."
From the 13 Principles of ICH (E6) GCP Guidance of Helsinki Declaration

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Who should attend?
This event is only open for non-commercial organisations; registrations from industry will not be accepted.

This event is only open for non-commercial organisations (i.e. MOH,local health authorities).

Those with responsibility for recording and managing Pharmacovigilance information (Physicians, Pharmacists, Technicians and Nurses).

Healthcare professionals managing/ involving in clinical trials activities in a Non-Commercial setting (i.e. MOH, health authorities and Universities), including pharmacists and technicians.

Researchers contributing to Clinical Trial.

Staff collecting,reviewing and reporting clinical trial data.

Clinical Trial Co-ordinators and Monitors

Registration

Online registration is open only for healthcare professionals who have been nominated officially by their medical district, facility or health authority to attend this training course.
Send your nomination letter as an attachment to info@cpd-pharma.ae

Need more information?
If you have any queries with registering or require further information please e-mail the CPD team at: info@cpd-pharma.ae or telephone on 02-6117495

Speakers/Trainer Form

Prof. Dr. İsmail Hakkı Ayhan	(Ankara University Faculty of Medicine Department of Pharmacology and Clinical Pharmacology)
Prof. Dr. Emin Kansu	(Hacettepe University Faculty of Medicine Institute of Oncology)
Prof. Dr. Murat Akova	Hacettepe University Infection Diseases Unit Internal Diseases Department
Prof. Dr. Hamdi Akan	(Ankara University Faculty of Medicine İbn-i Sina Hospital, Hematology Department)
Dr. Oğuz Akbaş	(Monitor Medical Research and Consultancy Ltd.)
H Ilbars
Nursah Omeroglu,CCRA

Training Objectives:
At the conclusion of this Two -day Good Clinical Practice course, participants should be able to:

Know the purpose of Good Clinical Practices.

The history and development of Good Clinical Practices.

The importance of informed consent to the clinical research process.

Researchers contributing to Clinical Trial.

How GCPs affect different clinical development activities.

The roles and responsibilities of sponsors, investigators, IRBs/IECs, and IDMCs.

Define the similarities and differences of GCP as per WHO, ICH, EU and FDA.

Learn the basic GCP terms – Sponsor, investigator, CRO, study documents, adverse events, etc.

Describe ethical concerns in clinical research and the principles of human protection.

Identify the important steps in patient recruitment and retention in clinical trials.

Properly categorize, handle and report adverse events.

Discuss the current regulatory framework in the UAE and the challenges in conducting clinical trials.

Agenda
Day One :
Time	Subject	Type
08:00 - 08:30	Registration
08:30 - 09:05	Opening
09:05 - 09:10	Introduction of AkademiKA®	Film
09:10 - 09:15	Sanofi-aventis and Clinical Research	Theoretical + film
09:15 - 09:30	What Do We Know About Clinical Research?	Evaluation (keypad)
09:30 - 10:00	Ethics and History of Clinical Research	Theoretical
10:00 - 10:30	What is Clinical Research?	Theoretical
10:30 - 11:00	Coffee Break
11:00 - 11:45	Methodology, Design and Methods of Clinical Research	Theoretical + Q&A
11:45 - 12:15	Terminology in Clinical Research & Interactive Case Discussion	Theoretical + Q&A
12:15 - 12:30	Discussion
12:30 - 14:00	Lunch
14:00 - 14:30	Helsinki Declaration & Principles of Good Clinical Practice (ICH-GCP)	Theoretical
14:30 -15:00	European Directive on clinical research	Theoretical
15:00 -15:30	US Regulations on clinical research	Theoretical
15:30 -16:00	Coffee Break
16:00 -16:45	What is Informed Consent ?	Theoretical + Workshop & Films
16:45 -17:15	Who is monitor? What is monitoring?	Theoretical + Workshop & Films
17:15 -17:30	Discussion

Day Two :
Time	Subject	Type
09:00 - 09:30	What is a protocol?	Theoretical + Workshop
09:30 -10:00	Source Document-CRF Relations.	Theoretical+ Workshop
10:00 - 10:30	What is Pharmacovigilance? Adverse Events and Reporting.	Theoretical+ Workshop
10:30 - 11:00	Coffee Break
11:00 -11:30	Responsibilities of Ethics Committees	Theoretical
11:30 -12:00	Responsibilities of Investigators	Theoretical + Film
12:00 -12:15	Responsibilities of Sponsors	Theoretical + QA
12:15 -13:30	Lunch
13:30 -14:00	SOPs/Audit/Inspection in Clinical Research	Theoretical
14:00 -14:30	Publication Ethics	Theoretical
14:30 - 15:00	What did we learn in Clinical Research? Evaluation of AkademiKA	Discussion
15:00 -15:30	General Discussion, Feed Back Survey, General Evaluation, Handling of Certificates
15:30 -16:00	Closing Remarks

Accreditation details:	9.2 CME Hours, MOHCME Accreditation ID # 0369 2009 Your attendance will be expected on BOTH DAYS

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Ministry of Health, Medical Practice and License Sector, Office of Pharmacy Continuing Education and Professional Development

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Definition:

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Agenda