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2014

Event 

Title:
4th National Pharmacovigilance Conference
Date:
05 Jun 14 - 06 Jun 14
Category:
Past Event 2014

Overview


Under the Patronage of H.E. Abdul Rahman Bin Mohammed Al Owais , Minister of Health , Public Health Policies and Licensing Sector, Drug department organize the 4th National Pharmacovigilance Conference which is continuation of the Pharmacovigilance training program for the Pharmacovigilance officers and Coordinators in UAE and it covers the following topics :

  • Pharmacovigilance Audit
  • Pharmacovigilance for biological and Biosimilars
  • Pharmacovigilance for Clinical Trials
  • Pharmaco epidemiology & Pharmacovigilance
  • Update in the World Guidelines (USA & Europe)
  • Pharmacovigilance System Master file
  • Benefit Risk Analysis
  • Signal Detection and Signal Management
  • PSUR and PBRER
  • Development of safety update reports

Objectives

Sorry, no description available

Who Should Attend?


Practicing Pharmacists

How to register?

Online registration 

Agenda

DAY 1

THURSDAY, 05 JUNE 2014 - Health Care Professional (HCPs), Pharma-companies & Ministry of Health

8:00 – 9:00

Registeration

09:00 – 09:40

Opening Ceremony
National Anthem and Holy Quran
Opening Speech &MOH Message: Dr. Amin Al Amiri, Assistant Undersecretary for Medical Practices & Licences Sector
Servier Message: Mr. Pierre Perez, General Manager-Gulf
Award Ceremony

09:40 – 10:00

Coffee Break

10:00 – 10:45†

The role of Pharmaco-epidemiology in Pharmacovigilance
Joanne Pilkington

10:50 – 11:35†

Pharmacovigilance for Biological and Biosimilars
Borislav Borissov

11:40 – 12:25†

Ideal Processing for an Individual Case Safety Report (ICSR)
Dr. Amr Saad

12:30 –14:00

Lunch Break

14:00 – 14:45†

Update in the world guidelines: Europe
Ms. Agnes Devois

14:50 – 15:35†

The new common Arab Guidelines in Pharmacovigilance
Dr Amr Saad

15:40 – 16:00

Coffee Break

16:00 – 16:45†

Signal Detection and Signal Management
Dr. Axel Thiele

16:50 – 17:30

Panel Discussion (Questions and Answers)

 

Day 2

FRIDAY, 06 JUNE 2014 - Pharma-companies & Ministry of Health

8:00 – 08:45

Registration

08:45 – 9:30†

The current Pharmacovigilance Practice in the Arab World
Dr Amr Saad

09:35 – 10:20†

Pharmacovigilance Audit
Ms. Agnes Devois

10:25 – 10:40

Coffee Break

10:40 –11:25†

Pharmacovigilance System Master File (PSMF)
Dr Amr Saad

11:30 – 12:15†

Pharmacovigilance for Clinical Trials
Joanne Pilkington

12:15 – 14:15

Prayer & Lunch Break

14:15 – 15:00†

Impact of New Regulation on Pharmacovigilance Inspection in Europe
Dr. Axel Thiele

15:05 – 15:50†

Benefit Risk Analysis and PSUR & PBRER
Borislav Borissov

15:55 – 16:10

Coffee Break

16:10 – 16:45

Panel Discussion (Questions and Answers)

†: The 5 minute gap between sessions is a 5-minute stretch

Speaker's Biography

Dr. AMR ABDEL MONEIM ABDEL RAHMAN SAAD, BPharm, MSc, PhD
Head of the Egyptian Pharmacovigilance Center (EPVC) and acting General Administrator for the Pharmaceutical Research at the Central Administration for Pharmaceutical Affairs (CAPA), and part-time clinical lecturer at Faculty of Pharmacy Ain Shams University, Misr International University (MIU) & Ahram Canadian University (ACU).
Dr. Amr Saad graduated in 2000 with the Bachelor of Pharmacy Degree and later otained his PhD Degree in Epidemiology from the University of Manchester (UK) in 2009. He has completed his Pre-Masters of Science in Clinical Pharmacy in 2002 and received his Masters of Science in Clinical Pharmacy degree in 2003.
Dr. Amr Saad has high academic and professional experience that includes his role as Head of the National Regulatory Egyptian Pharmacovigilance Committee, Head of the working group to introduce the eCTD to the Egyptian Drug Authority (EDA), Lecturer of clinical pharmacy at Cairo University & Future University of Egypt (FUE). He has been the Founding member in the Egyptian Clinical Pharmacy fellowship Scientific, Editorial and Steering committee
He has worked as a Member of the three committees responsible for establishment and updating Egyptian Lists for Essential Drugs (EDL), Life Saving Drugs (LSD) and Over the Counter medicines (OTC), been a Co-ordinator for the Arab League`s subcommittee to reach a unified Arab Pharmacovigilance Regulation, Head of the Arab League`s High Technical committee for common Arab Guidelines for Arab Drug regulations, Peer reviewer for the International Journal of Clinical Pharmacy (IJCP).
He is specialized in Research Mentoring & Thesis Supervision He has a done a lot of research in his career and has many publications in various journals.

Ms. AGNES DEVOIS, MD
Pharmacovigilance and Clinical Investigation Division Director, Servier Laboratories
Ms Agnes Devois joined Servier in 2005 as Pharmacovigilance Project Manager - Servier Laboratories and was then promoted as its Clinical Investigation Division Director. She has also been employed as a Medical Examiner for National Gendarmerie Criminal Research Institute.
She is a valedictrian in Forensic Medicine speciality, Criminalistics Diploma, National Gendarmerie Criminal Research Institute, Corporal Damage Compensation Aptitude Certificate & Corporal Damage Compensation Diploma. She is also a qulaified Medical Doctor with a Silver Medal.

Ms. JOANNE PILKINGTON
Freelance Clinical Research Professional. Currently working as Clinical Trial Manager at Gilead
Dr. Joanne Pilkington graduated in 1993 with a B.SC (Hons) in Zoology from the University of Edinburgh. In 2004, she did her Post-graduate diploma in Companion Animal Behaviour Counselling, Southampton University and in 2010, completed Diploma in Professional Coach-Mentoring from the Oxford School of Coaching and Mentoring.
Her vast work experiences include working as an European Contractor Manager with Clinical Professionals ; With Glaxo Smithkline from 1995 to 2010 in various positions. Her profile also includes working with GW Pharmaceuticals & Novartis Pharmaceuticals.

Dr. AXEL THIELE
Chemist, Director and Professor at Federal Institute for Drugs and Medical Devices and also Head of Unit Risk Management Procedures and Pharmacovigilance Inspections.
Dr. Axel Thiele has completed his Study of Chemistry at FU Berlin in 1976 and was conferred a Directorate in 1977. He did his Research Work on the Topic X-Ray Structure Analysis of Heteropoly-Compounds Academic Assistant at the Institute of Inorganic Chemistry at FU Berlinfrom 1976-1981
His work experiences include: Associate at the Institute of Drugs of the Federal Health Authority at the Department Post Marketing Surveillance - Pharmacovigilance and Deputy Head of Pharmacovigilance Department.
He is an Assistant Lecturer at the Rheinische Friedrich-Wilhelms-Universität Bonn and the Humboldt-University Berlin, Academic at the Beuth-Hochschule für Technik, Berlin and Member of the Ad Hoc Pharmacovigilance Inspectors Working Group, London.

Dr. BORISLAV N. BORISSOV
General Manager of Prescriptia Ltd Bulgaria and Prescriptia S.a.r.l, Switzerland Managing Director of Synexus Bulgaria Ltd, a member of Synexus Clinical Research UK
Dr. Borislav N. Borissov completed his MD, Medical Faculty, Sofia in 1990 and later on in 2002, finished his MBA for Executives from City University, Bellevue, WA
His work experiences include working as ICU, Department of Intensive Care, Medical Faculty, Sofia from 1990 to 1993 and proceeded to work as a Consultant in Intensive care, Medical Faculty, Sofia from 1994-1998. He was also the Executive Director, Bulgarian Drug Agency from 1998 to 2004. His Post-Graduate Activities include ICU, University hospital “St. Margueritte”, Marseille, France - Clinical research in heart and lung transplants ; Addenbrooke’s hospital, Cambridge, UK - clinical research in liver transplants ; Summer University of Montreal in Ascona, Switzerland- Organizational strategies: designing client-oriented program. Tutor: R. Desmarteau

CME Accreditation

 Under process

Other Info


Supported / Sponsored by

Les Laboratoires Servier 

Organised by


For More Information


Venue

Venue:
J W Marriott Dubai   -   Website
Street:
Abu Baker Al Siddique Rd, Deira, next to Hamarain
ZIP:
T042624444
City:
Dubai
State:
Dubai
Country:
Country: ae