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2016

Event 

Title:
Good Clinical Practice (GCP) Training Program
Date:
02 Nov 16 - 03 Nov 16
Category:
Past Event 2016

Overview

Under the patronage of
H.E. Abdul Rahman Al Owais
UAE Minister of Health& Prevention
the Public Health Policy & Licensing Sector, Drug  Department,
in collaboration with
SANOFI as part of executing the " Integration Initiative" plan for 2016
are proud to announce:
“Good Clinical Practice (GCP) Training Program”
2nd& 3rd November 2016
  تحت الرعاية الكريمة لمعالي الاستاذ /عبد الرحمن بن محمد العويس - وزير الصحة و وقاية المجتمع
ينظم قطاع سياسة الصحة العامة والتراخيص - ادارة الدواء
وبالتعاون مع  شركة سنوفي
تنفيذاً لبرنامج "مبادرة تكامل" لسنة 2016
البرنامج التدريبي في
اسس الممارسة السريرية الجيدة
2و 3 نوفمبر 2016

Objectives

Good Clinical Practice (GCP) is an international ethical and scientific quality standard set for monitoring, designing, conducting, recording, analyzing and reporting clinical trials involved human subject.

 

Topics covered during this training event, include:

The purpose of Good Clinical Practice

The Declaration of Helsinki and development of Good Clinical Practice (ICH-GCP) guidelines

The basic GCP terms – sponsor, investigator, CRO, study documents, adverse events, etc

The critical path of the clinical trial and the roles and responsibilities of Ethics Committees, sponsors and investigators including the clinical trial documentation

The importance of informed consent in the clinical research process

How GCP affects different clinical development activities

Safety reporting in clinical trials & Study data collection

 

This training program is intended for the following audience:

Ministry of Health and Prevention, local Health Authorities in UAE: officials from Public Health, Research Policy & Regulation Sector

GCC Officials: From Research Public Health, Policy & Regulation sector

Ethics Committees in UAE: including EC Chairman & EC scientific & lay Members

Healthcare Professionals at academia, pharma industry , public & private sector: Pharmacists, Specialists, GPs, PHC family physicians  


Who Should Attend?

This training program is intended for the following audience:

Ministry of Health and Prevention, local Health Authorities in UAE: officials from Public Health, Research Policy & Regulation Sector

GCC Officials: From Research Public Health, Policy & Regulation sector

Ethics Committees in UAE: including EC Chairman & EC scientific & lay Members

Healthcare Professionals at academia, pharma industry , public & private sector: Pharmacists, Specialists, GPs, PHC family physicians  

How to register?

Kindly Note :- Registration for this event is been closed.

Agenda

Agenda - Day 1 - Wed 2 November 2016
8:30 - 09:30

Welcome and Registration

09:30 – 09:40

Introduction of Brookwood International  Academy

Dr Colin Wilsher - Brookwood international Academy

09:40 – 10:00

An insight on the Ministry of Health and Prevention Research Ethic Committee – Questions & Answers

 

Dr. Suad Hannawi  - Deputy Chair of the Research Ethic Committee

10:00 – 10:20

What Do We Know About Clinical Research?

Evaluation (keypad)

Dr Colin Wilsher/ Trish Parry

Senior Associate Trainer

10:20 – 10:35

Declaration of Helsinki  & Principles of Good Clinical Practice (ICH-GCP)

 

Theoretical

Dr Colin Wilsher/ Trish Parry

Senior Associate Trainer

10:35- 11:00

Coffee Break 

11:00 – 12:00

Safety reporting in clinical trials

Theoretical

Dr Colin Wilsher/ Trish Parry

Senior Associate Trainer

12:00 - 13:00

Lunch & prayer

13:00 - 14:30

Critical path of the clinical trial and the responsibilities of ethics committees, sponsors and investigators, including clinical trial documentation

Theoretical

Dr Colin Wilsher/ Trish Parry

Senior Associate Trainer



14:30 – 15:00

Coffee Break

15:00 – 16:15

Opening Ceremony

- National Anthem
- Holy Quran
- H.E. Abdul Rahman Al Owais Speech, UAE Minister of Health
- H.E. Amin Al Amiri Speech, Assistant undersecretary for Medical Practice and License
- Dr. Jean Paul Scheuer Speech; Sanofi Country Chair and General Manager - Gulf Countries and Yemen
- Dr. Abdullah Al Khayat Speech; Vice President "Research Ethic Committee"
- Research & Development at Sanofi (Video)
- Award Ceremony

 

End of Day 1



Agenda - Day 2 - Thu 3 November 2016
08:30 – 09:00 Re-registration day 2
Workshops will run in one meeting room
09:00 – 09:10 Welcome and opening
Introduction to workshop day 
09:10 – 11:00 Introduction to Good Clinical Practice Refresh critical path. Give tables a critical path and ask them to match GCP requirements to the segments. Dr Colin Wilsher/ Trish Parry.Senior Associate Trainer
  What is ICH GCP, why is it needed, how does it fit with national & international regulations, importance of having and working to protocol and SOPs. Audit and inspection.    
  Overview of key GCP requirements in the critical path of the clinical trial    
11:00 – 11:30 Coffee Break
11:30 – 12:45 Ethics and Informed consent in clinical trials Show film of Graham (only) delivering a consent Dr Colin Wilsher/ Trish Parry.Senior Associate Trainer
  Study documents -- the investigator's trial master file and common inspection findings Brainstorm documents list according to pre, during and post using critical path sheet  
12:45 – 13:45 Lunch & prayer
13:45 – 15:00 Requirements of an investigator and study site performing global clinical trials Investigator diamond 9 exercise. Keypad session presenting examples of safety issues and determination of SUSAR Dr Colin Wilsher/ Trish Parry.Senior Associate Trainer
  Safety reporting in clinical trials ( Interactive key pads exercise to classify adverse events)    
15:00 – 15:30 Coffee Break
15:30 – 16:30 Collecting study data Short recap on how to correct data. Exercise to determine meaning of ALCOACEE. Dr Colin Wilsher/ Dr Trish Parry. Senior Associate Trainer
  Interactive exercise on ALCOA word meanings    
16:30 – 17:00 GCP Quiz (Test Knowledge gained)_ Keypad
17:00 – 17:30 End of Day 2 - Closure of the training & Group Photo

Speaker's Biography

The Chair Person 

Dr. Amin Hussain Al Amiri

Asst. Undersecretary for Public Health Policy & Licensing

Ministry of Health and Prevention – UAE


Speakers

Dr. ABDULLA Ibrahim Al Khayat

Professor of Pediatrics, Counsellor of Medical Affairs

Chair of the Central Research Ethic Committee

Ministry of Health and Prevention – UAE


Dr. SUAD HANNAWI 

Consultant of Medicine & Rheumatology

Ministry of Health and Prevention – UAE


Brookwood International Academy Speakers

Dr. Colin Wilsher 

Senior Training Associate


Ms. Trish Parry  

Senior Training Associate

 

Organizing Committee

Dr. Amal Mohamed Saeed AlAwadhi

Head of Drug Department

Drug Department, Ministry of Health and Prevention– UAE


Dr. Ola Ghaleb Al Ahdab

Researcher, Pharmaceutical Advisors & CPD Project Manager

Drug Department, Ministry of Health and Prevention– UAE


Dr. Ehab Abu Eida

Expert/ Consultant

Drug Department, Ministry of Health and Prevention– UAE


Dr. Fatima bin Jarrah

Head of Drug Registration Section

Drug Department, Ministry of Health and Prevention– UAE


Ms. Fatima Mohammed Alsalfa

Executive Secretary, Asst. Undersecretary of Public Health Policy & Licensing Office

Ministry of Health & Prevention– UAE


Dr. Nezha El Yossri 

GP Pharmacist

Drug Department, Ministry of Health and Prevention– UAE


Dr. Mohammed Ismail

Head of Medical/Country Medical Chair, Sanofi-Gulf


Dr. Lilya Ziad

Clinical Operations Manager, Sanofi-Gulf


Mrs. Nahid Omar

Events Management, Sanofi


Dr. Dalia Fouad

Head of Regulatory Affairs, Sanofi

 

 

The training will be conducted by Brookwood International Academy




Academy Company Info

CME Accreditation

By: MOHAP Training and Development Center 
Accreditation # MOHAP/CPD/16/1232)  
Day 1: 4.0 CPD/CME/CPE
Day 2: 4.0 CPD/CME/CPE  
 
General Guideline
As per the MOHAP Accreditation guideline, kindly be informed that:
o    All speakers/presenters participating in your accredited program should have no potential conflicts of interest or support that might cause a bias in their presentation.
o    No promotional activity or material shall be held in concurrent or contiguous with the CME/CPD program schedule. It has to be separated clearly from the scientific program. The only form of promotion permitted is the acknowledgement that the company has contributed to the educational program by provision of a grant.
o    No drug or product advertisement should appear on the scientific program or with any of the written materials (preliminary or final programs, brochures, or advance notifications) for the event.
o    CPD Certificates:
  CPD Certificates should be provided only after participants completed the educational activity so you can document participation. 
  As an organizer of CPD accredited event, you are responsible to make sure that credit certificates are provided only to those who participated in the activity and completed its requirements. For participants who failed to attend the activity in full, they will only be eligible to receive credit points for the parts in which they have actually participated. 
  "This Program has been awarded (….) CPD Credit Hours by the UAE Ministry of Health and Prevention “(Accreditation # MOH/CPD/16/xxxx)" should be stated clearly in the provided certificate.
  The organizer may issue other certificates (e.g. Appreciation Certificate or Attendance Certificate) that do not mention CPD or MOHAP using Commercial Interest logos.
o    This approval is valid for the calendar year of 2016 only.
o    For the purpose of ensuring quality and compliance with the guidelines, MOHAP Accreditation representatives have the right to randomly inspect/attend these activities without prior notification. The MOHAP preserves the right to modify the number of credit hours granted as necessary.
o    MOHAP Accreditation reserves the right to cancel/suspend privileges for current/future activities organized by any CME/CPD Provider involved in the planning of activities that do not comply with these rules. 

Other Info

cpd-pharma-events@mci-group.com

Supported / Sponsored by

SANOFI

Organised by

MOHAP& SANOFI

For More Information

cpd-pharma-events@mci-group.com

cpd-pharma@moh.gov.ae 

Venue

Dubai Intercontinental Festival City
Venue:
Dubai Intercontinental Festival City
Street:
Intercontinental Festival City
ZIP:
1234
City:
Dubai
State:
Dubai
Country:
Country: ae