概要

In a rapid changing environment, pharmacovigilance plays a key role in maintaining the focus on patient safety. Middle East & Africa Regions are gaining more space in the pharmaceutical landscape with the innovation and development of new medicines.

This workshop’s aim is to bring together key stakeholders from different regions to share good practices and requirements into getting the actual guidelines into practice.

The conference format is designed to stimulate dialogue and generate solutions through a series of interactive sessions and workshops conducted in an informal setting allowing for in-depth discussion in smaller groups.

特集トピック

参加対象

Established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance, including:

Signal management
Risk Management Planning
PSMF maintenance
Clinical Trials

Professionals involved in:

Drug Safety/Pharmacovigilance
Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
Benefit-risk assessment and communication
Medical Product Safety Assessment
Regulatory Affairs
Clinical Trials
Pharmaceuticals, biologics, combination products, devices
Clinical Research and Clinical Research Organizations
Health Outcomes
Academic Research Centers
Regulatory Agencies

学習目的

Seek direct answers to the business challenges you are facing every day
Understand how other organisations are managing through the shift of sharing all information to sharing relevant information
Ensure that your pharmacovigilance work matches up with inspector expectations, and delivers the efficient outcomes for patients.

プログラム委員会

Shahinaz Badr, PharmD Pharmacovigilance Consultant and PVQA Auditor - EMEA
Independent Consultant, United Arab Emirates
Sean Burke, MSc (EFPIA IPVG Representative) Pharmacovigilance Lead, EEMEA
Merck , United Kingdom
Dana Isleem Pharmacovigilance Manager
Bristol-Myers Squibb , Saudi Arabia
Raghda Mohamed Patient Safety & Pharmacovigilance Cluster Lead - West Gulf, East Gulf and Leva
Takeda, United Arab Emirates
Shanthi Pal, DrSc, MPharm Group Lead, Medicines Safety, Safety & Vigilance
WHO, Switzerland
Reem K Al Essa, MBA Coordination & Development Superintendent Pharmaceutical Services Administration
Ministry of Health, Kuwait
Sultana Essa Omar Ali Bin Haider Pharmacovigilance Officer, Drug Department
Ministry of Health & Prevention, United Arab Emirates
Nadjat LOUMI-MEDEDJEL Responsible for Training of Healthcare Professionals and Staff
Centre National De Pharmacovigilance et De Matériovigilance (CNPM), Algeria
Manal Younus Head of Iraqi Pharmacovigilance Centre, Directorate of Technical Affairs
Ministry of Health, Iraq
Hadir Rostom Head, Egyptian Pharmaceutical Vigilance Center (EPVC)
Pharmaceutical Affairs Central Administration (CAPA), Ministry of Health, Egypt, Egypt