Pharmacovigilance and Drug Quality Control are among those fields which have been identified as priority areas by the First Meeting of the ECO High Level Drug Regulatory Authorities (HLDA) held in Tehran on 13-15 November 2007.
The “Pharmacovigilance” and “Drug Quality Control” Workshops were held on Tehran from 19-21 July 2010. The Workshops were hosted by the Ministry of Health and Medical Education of the Islamic Republic of Iran, Deputy for Food and Drug, in collaboration with the ECO Secretariat.
Delegates from all ECO Member States namely: the Islamic Republic of Afghanistan, the Republic of Azerbaijan, the Islamic Republic of Iran (Host), the Republic of Kazakhstan, Kyrgyz Republic, the Islamic Republic of Pakistan, the Republic of Tajikistan, the Republic of Turkey, Turkmenistan and the Republic of Uzbekistan participated in the Workshops.
The objectives and expected goals of these workshops were to give an opportunity to the participants to share the latest breakthroughs on quality control of biological and non-biological medicines and findings on pharmacovigilance among the ECO Member States. The participants highlighted the strong or vulnerable points of Member States based on which a more practical joint work plan can be formulated. They were also able to learn:
- how to develop National Adverse Drug Reaction Monitoring Center in the country
- how to implement Spontaneous Reporting System in the country
- how to identify and evaluate adverse drug events through better reporting systems, skilful technical investigation of incidents and responsible sharing of data, develop capacity to anticipate adverse events and to probe systemic weaknesses that might lead to problems
- identify existing knowledge resources, within and outside the health sector
- make improvements in the health-care delivery system
The workshops were conducted in an interactive manner and the programme consisted of presentations, discussions, group activities. The presentations covered most of the aspects of pharmacovigilance and drug quality control. During each presentation, the participants were invited to share their experiences and achievements made by their respective countries relating to the areas covered in the presentations. Questions raised by the participants were addressed by the presenters and the facilitators.
Dr. M. H. Nicknam, Acting Health Minister for International Relations Affairs, inaugurated the Workshops. Amb. Hassan Taherian, the ECO Deputy Secretary General and Dr. M. R. Shanesaz, Director General of Division of Pharmaceutical Affairs , Iranian MOH, also made statements during the inaugural session.
During the workshop, scientific presentations on the following subjects were delivered by the Iranian eminent experts and scientists: Methods Available for Drug Safety; Medication Errors; Definitions and Mechanisms of Adverse Drug Reactions; Preventable Adverse Drug Reaction; Individual Causality Case Assessment; The role of Food and Drug Control Laboratories (FDCL) on Drug Quality Control; Overview of Drug Regulations in Iran; Quality Assurance; Good Laboratory Practice (GLP); Method Validation; Medical Biotechnology Trends; Quality control of Blood Products; Physico-Chemical Quality Control of Vaccine; Quality Control of Genetically Modified Organisms Products; Quality Control of Recombinant Proteins.
Two group activities focusing on “How to Evaluate and Report Suspected ADRs” and ‘Quality Control of Vaccines’ was undertaken. The participant actively participated in the group activities and each group demonstrated the presentation prepared by them.
The participants visited the Jaber Ebne Hayyan Pharmaceutical Company located in the outskirts of Tehran city. A visit to the Production & Research Complex (Karaj) of the Pasteur Institute of Iran was also arranged on Thursday, 22nd July 2010.
At the last leg of the Workshops, the participants were taken to see SaadAbad Cultural & Historical Complex, which is stretched on 110 Hectare land. There are a number of museums as well as traditional restaurant and coffee shops. The participants were happy to visit this complex.
The participants thanked the Iranian Ministry of Health and the ECO Secretariat for making excellent arrangements for the Workshops.
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