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 ISoP 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.

Training programme

ISoP Middle East Chapter Scientific Committee

• Dr. Thamir Alshammari
  Medication safety research chair, King Saud University, Riyadh, Saudi Arabia
• Dr. Manal Younus
  Head of Iraqi Pharmacovigilance, Ministry of Health, Baghdad, Iraq
• Dr. Sameh Alzubiedi
  Associate Professor of Clinical Pharmacology, College of Pharmacy, University of Jordan.
  Director of the University Pharmacovigilance Unit, Amman, Jordan
• Magnus Ekelo
  Uppsala Monitoring Centre

ISoP Middle East Chapter Pharmacovigilance Training programme

ISoP Middle East Chapter webinar
Wednesday 23 March 2022 at 19.00 UTC+3
2nd edition of the webinar ‘COVID-19 Vaccines Safety Surveillance in Arab Countries’, highlighting Jordan and Lebanon experience.

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ISoP Middle East Chapter webinar
Wednesday 27 January 2021
‘Covid-19 vaccine from all angles: focusing on safety information’.
In collaboration with the World Health Organization (WHO) and World Health Organization Eastern Mediterranean Regional Office (EMRO).

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ISoP Middle East Chapter webinar series “Medication Safety Program”.
The program will run over 7 weeks starting from August 31 2020.

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ISoP Middle East Chapter webinar
“Business continuity of pharmacovigilance in COVID-19 era”
Tuesday 9 June 2020, 17.00 London time (BST)

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5th ISoP Middle East Chapter Pharmacovigilance workshop
17-18 November 2019 – Dubai, UAE
Middle East Chapter-MedDRA Workshop.

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30-31 August 2018 – 2nd Middle East Chapter and Iraq Ministry of Health
Joint pharmacovigilance training held in Baghdad (Iraq).

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18-19 April 2018 – 2nd Middle East Pharmacovigilance Training – Dubai, UAE
Middle East Chapter-MedDRA Workshop.

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17-18 March 2018 – Middle East Chapter and Iraq Ministry of Health joint pharmacovigilance training

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12-13 April 2017 – 1st Middle East Pharmacovigilance training, in collaboration with the ISoP Middle East 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 (ISoP 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.