Chapters - Middle East
As Pharmacovigilance is slowly increasing in the region, we have taken the initiative to solidify and standardize the Pharmacovigilance regulations through the implementation of new regulations and to enhance the Pharmacovigilance practice in the area.
The Middle East Pharmacovigilance chapter is recommended in order to harmonize Pharmacovigilance practices, regulations between all the Arab countries.
The chapter will commit to join forces with the Ministry of Health in the Middle East towards the execution of and compliance with the new Arab guidelines.
The chapter will have the mission to utilize the existing strengths on academic and health industry levels to enhance Pharmacovigilance and to establish the highest international standards in the region.
- To foster collaboration between Pharmacovigilance members across Middle East region
- Sharing of experiences for evolution of the new Arab guidelines
- Increase awareness on the importance of enhancing patient’s safety in the region
- Strengthen the risk management implementation via marketing authorization holders and regulatory agencies
- Discuss needs and opportunities of each country to strengthen the Pharmacovigilance system.
Our goal is to create a partnership with ISoP and to establish the future of pharmacovigilance in the region.
All persons interested in pharmacovigilance activities in the region are welcome and invited to be a member of ISoP and the Middle East Chapter. Join ISoP here
Please contact ISoP Aministration for further information.
12-13 April 2017 – 1st Middle East Pharmacovigilance training, in collaboration with the Middle East ISoP Chapter.
First ISoP Middle East Chapter Pharmacovigilance Training Workshop!
A total of 40 participants from pharma industry (public and private sectors), research institutions, academia from across different Arab countries gathered to attend the first pharmacovigilance training workshop that was organized by the ISoP Middle East (ME) chapter in Middle East region on 12th and 13th April 2017, in Dubai, UAE. The agenda was managed by a scientific committee within the ISoP ME chapter.
The objective of the training was to share best practices in implementing pharmacovigilance system with lessons learned from Middle East and European experts. The focus areas of the training were European regulations and Arab Guidelines, understanding and execution, challenges and practices.
The two days’ program covered different pharmacovigilance topics. The first day included Individual case safety report (ICSR) reporting, collection, assessment and signal detection, periodic benefit risk evaluation report (PBRER) within the Arab guidelines. It also covered some topics around risk management plan, risk communications, medication errors and off label use.
The second day discussed some differences between European and Arab guidelines with respect to the pharmacovigilance system master file (PSMF), post authorization safety studies (PASS). The program also touched on the use of epidemiology methods in pharmacovigilance and pharmacovigilance requirements for clinical trials.
The workshop was conducted by ISoP members and regional experts in pharmacovigilance and international experts. They are Dr. Mayada Alkhakany (president ISoP Middle East chapter, head of PV –Boehringer Ingelheim), Dr. Thamir Alshammari (vice president ISoP Middle East chapter, Dean of College of Pharmacy, University of Hail), Dr. Brian Edwards (Principal Consultant, Pharmacovigilance & Drug Safety and Board Member, ISoP), Dr. Ola Ghaleb Al Ahdab (pharmaceutical advisor, CPD pharma program manager MOHAP – UAE).
The training was well appreciated by the participants who recommended that it be repeated several times in order to strengthen pharmacovigilance concepts in Arab countries through innovative approaches in training programs.
Current Coordinating Group:
Dr. Mayada Alkhakany,
Head of Pharmacovigilance-META
Vice President – Deputy:
Dr. Thamir AlShammari
Dean of Pharmacy College
University of Hail