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Advanced Course on PV: Harmonization for efficient Drug Surveillance

Eritrea has achieved the Millennium Development Goals with great success and received worldwide acclaim. What has so far been accomplished is incomparable with many African countries. Parallel to this, Eritrea has assured its commitment in the realization of Pharmacovigilance and Risk Management. For instance, the number of reports it continues to send to the WHO has ranked the country second from African countries. The comprehensiveness of the report makes Eritrea stand first among all African nations.

To strengthen its commitment and to share regional and international experiences, Eritrea is conducting an East African Advanced Course on pharmacovigilance and Risk Management starting from 10-17 April 2016, which is the first of its kind in Africa, under the theme “Safe drugs and vaccines to market by analyzing latest developments in Pharmacovigilance (PV), drug safety and risk management Strategies in East Africa”.


The regional advanced course is being carried out in collaboration with the Ministry of Health of Eritrea, WHO and other partners. In this course, more than twenty-four experts of the field from 17 countries mainly from Africa, Europe, America and Asia are attending.

The main objective of advanced course is to strengthen the regulatory system of the countries and to create a way forward for accelerating Pharmacovigilance harmonization in East and Horn Africa, while discussing the challenges and opportunities of drug safety related issues, according to Dr. Menghis Bairu, Founder and Chairman of Emeritus and Serenus Bioterapeutics.

In the opening ceremony conducted at the Asmara Palace Hotel, Dr. Menghis said that hosting such advanced courses in Eritrea reflects to what Eritrea has so far gained in the provision of fairly good healthcare service depending on its local resources. Noting that 35-40 % drugs exported to Africa are falsified; the course on PV and risk management is expected to prompt the East and Horn African countries to come together and build systems of combating and regulating PV harmonization, so as to avoid and minimize medicine harms.

Present on the opening session of  the course, Ms. Amina Nurhussien, Eritrea’s Health Minister, said that the participation of internationally prominent experts in their respective domains positively adds to the prestige and value of the gathering. The Minister went on to say that the East Africa Advanced Course and Conference on Pharmacovigilance is very timely in the sense that it came at a period when Eritrea is taking the necessary measures to build an effective Pharmacovigilance center.

As regards Eritrea’s commitment to public safety and international solidarity, the Minister said that Eritrea has joined the WHO Program for International Drugs Monitoring as a full member in 2012 and since then much has been done on Pharmacovigilance with remarkable achievements.

Dr. Josephine Namboze, WHO representative in Eritrea, gave remarks regarding the lack of harmonized and ineffective PV system in Africa. Such ineffective regulatory mechanisms continue to be the core reason for the distribution of falsified and sub-standardized medicines in the continent and is becoming the cause for health related complications, ultimately leading to deaths. To eradicate such occurrences and to further enhance the regulatory competence of healthcare professionals and to increase societal awareness, Dr. Josephine elaborated that the East African Advanced Course on Pharmacovigilance and Risk Management which Eritrea is hosting is highly crucial in tackling and taking immediate action against the distribution of unsafe medicines in the continent.

Stating that distribution of falsified medicine was highly seen in Africa in 2015, Dr. Michael Deats, Medical safety, Surveillance and Monitoring systems on SSFFC Medical Products, WHO, presented a research based findings related to various ineffective drugs which are causing serious problems in the lives of African people especially on children. To overcome the problem, developing proactive Pharmacovigilance and Risk Management strategies in Africa is a timely mitigation measure is the opinion Dr. Michael shares with the participant of the course.

Concerning to the Eritrean PV status, Mr. Iyassu Bahta, Director of National Medicine and Food Administration in the Ministry of Health, highlighted the overview of Eritrea’s achievement in establishing national PV center, capacity building, active surveillance and maximizing ADR detection and effective reporting system. He further pointed out that Eritrea is making steady progress in strengthening PV regulatory systems.  The way forward for hosting such important course is to expand national integration and regional harmonization among African countries as well as at international level. How to build an effective PV system was presented by Sten Olsson, WHO Program Expert, Uppsala Monitoring Center, while Effective Communication in PV was delivered by Bruce Hugman, Uppsala Monitoring Center, Global Communications Team.

Assessment and Medical Evaluation of Individual Case Safety Report (Including practical case studies) was presented by Prof. Ambrose Isah, Consultant Physician and Pharmacologist and by Mr. Mulugeta Russom, head of Eritrea’s Pharmacovigilance Center.

Mr. Mulugeta gave briefings as regards to side effects of anti-malaria pills based on a research conducted in Eritrea. He explained to the participants of the advanced course that Eritrea follows extensive and rigorous control mechanisms to assure its public safety mandate. So far, the country has registered commendable achievement and is looking forward to learn lessons from other countries so as to upgrade its PV system through being part of regional and international endeavor.

Risk and benefit balance of drugs is among the recurrent ideas extensively discussed in the current advanced course. Hence, the primary objective of suchlike course is aimed at ensuring public safety through sharing best practices among participant nations. Avoiding medicine related problems is the prevalent agenda of the course that is still underway at Asmara Palace Hotel. Reduction of potentially preventable drug related complications and the severe health problems that could emerge along with the usage of counterfeit products and the possible regulatory measures that should be taken is what this course is all about.

The course was really a platform for PV related discussions and sharing of scientific approaches about the different medical practices and experiences among participant nations. Each presentation was followed by extensive deliberation which actually leaves no room for confusion.  PV systems currently used in Africa, Asia, America and Europe were equally shared.

PV system optimization in East Africa through sharing best medical practices from around the world is what Eritrea has been looking forward, and the launching of this extensive sharing of views as regards common and unique challenges related drug safety issue is a basic strategy in the efforts being exerted towards development and distribution of equality medicines.

In the pre-course meeting held on 10 April 2016, lessons about PV and risk management learned from various countries such as Burundi, Kenya, South Sudan, Cape Verde, Eritrea, Morocco and Afghanistan were presented.

In the discussions and sharing of experiences of 12 April 2016, topics such as Principles of Signal Detection, Signal Analysis and Signal Strengthening as well as From Signal to Action were presented by Prof. Eugene Van Puijenbrock, Clinical Pharmacologist and Head of the Science and Research Dept. Netherlands PV center and also by Mr. Sten Olsson. And each presentation was extensively discussed.

In the afternoon session of the same day, Signal Detection Relevant to low income and middle income countries, by Mr. Sten Olsson, Effectiveness/Risk Assessment in Pharmacovigilance by Prof. Alex Dodoo, clinical pharmacologist, director, WHO-Collaborating Center for Advocacy and Training in PV, and finally Crisis Management in Pharmacovigilance by Bruce Hugman, Communications expert, Global Communications Team were the topics which the participants keenly attended and extensively shared views.

In the regional Advanced Course on Pharmacovigilance and Risk Management that would continue until 17 April 2016, experts from South Sudan, Morocco, Ghana, Burundi, Tanzania, Sudan, Kenya, Cape Verde, Nigeria, Afghanistan, Thailand, Switzerland, Netherlands, UK, UAE and the US are taking part.

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