Pharmacovigilance Today in MENA Region

Dubai, September 3, 2015: Following last year’s success, 2nd Pharmacovigilance workshop, supported by UAE ministry of health, reinforces the importance of collaboration and dialogue between Pharmacovigilance representatives from the local Pharmacovigilance centers in the Arab countries. The workshop provides a platform to share the execution of the new Arab Guidelines and highlight key solutions with the ultimate purpose to drive the Pharmacovigilance regulations forward

The program includes presentations and interactive discussions covering topics such as; post execution of the New Arab Guidelines, ISOP PV chapter, inspection tools, communication channels and ensuring medication safety through the use of Technology and Innovation.

Objective:

• Providing in-depth practical guidance to the Pharmacovigilance members of HAs would have one harmonized way of execution of Arab Guideline across the region.
• Sharing of experiences and continued dialogue and collaboration between Pharmacovigilance members of HAs for evolution of the new Arab Guideline. 
• Discuss needs and opportunities at country level for strengthening the Pharmacovigilance system.
• Introducing ISOP organization in the MENA region.

At the end of this event you should be able to:

• Understand in depth the Common Arab Guidelines after July 2015
• Explore Big Data and the potential in Pharmacovigilance and Risk management
• Learn about new social media programs in Pharmacovigilance and how can add value in collecting ADRs and implementing of RMP.
• Gain insight into how benefit risk assessment of marketed products.
• Discuss the needs and opportunities at country level for strengthening the Pharmacovigilance system.

Arab Guidelines:
With the increasing and ever- more stringent regulations in Pharmacovigilance, the regulatory authorities face greater demands for patient welfare and safety. These in turn necessitate standard levels of monitoring and data analysis that ensure safe drug delivery. This can be only attained by well-structured Pharmacovigilance centres backed-up with a robust legal framework and clear guidelines. Arab ministers of health came to a common decree (number 7) in their 37th regular meeting in March 2012 à ‘The Higher Technical Committee for Medicines’ was established with representatives from all Arab countries à create common Arab guidelines in Pharmacovigilance, and in bioequivalence. This committee elected Dr. Amr Saad, head of the Egyptian centre, to lead the committee across all its rounds. The committee finished the final drafts of the two common guidelines which were submitted to the 41st regular ministers meeting March 2014 (decree number 9) .The new guidelines is mainly adapted from the newly-established international Good Pharmacovigilance Practice. Composed of 15 different modules together with some product/population specific considerations, as well as annexes and templates of submission. The Guidelines were published in March 2014 and the effective date was 1st July 2015.

International Society of Pharmacovigilance (ISOP)
A professional, independent, non-profit society, open to anyone with an interest in the safe and effective use of medicinal products.

ISoP aims to foster science and learning in Pharmacovigilance in all countries

We do this by providing

• Opportunities for networking in a friendly environment
• Collegial and convivial support among fellow Pharmacovigilance professionals
• An open and impartial forum for sharing experience and knowledge
• A platform for discussion and generation of new research and ideas
• Meetings, education and affordable training

In the view of ISoP, the scope of Pharmacovigilance is:

Any area that contributes better knowledge and understanding of the safe and effective use of medicines, pre- and post-marketing, including but not limited to

• Problems related to the active components and ingredients of medicinal products
• Problems related to medicines use, e.g.
  • Prescription, dispensing, administration errors
  • Adherence to the treatment
  • Misuse, abuse, recreational use of drugs of addiction
  • Poisoning, accidental overdose
• Substandard/spurious/falsely-labelled/falsified/ counterfeit (SSFFC) medical products
• Safety problems in relation to mass medication (e.g. vaccines)
• Antimicrobial resistance and other treatment failures
• Benefit-harm assessment and risk management
• Quality issues related to manufacturing, transport or storage
• Environmental effects
• Regulatory matters pertaining to the above