Best European Practices on the Medicines Regulation Being Introduced in Armenia 
CAPS Project supports the development of the pharmaceutical industry using both its own potential and the capacities of other projects. In certain cases, through the consultancy of CAPS, industry companies are referred to other international donor programs, which can provide assistance relevant spheres.
A vivid example of this is TAIEX (Technical Assistance and Information Exchange instrument of the European Commission) Program, which assists partner countries in the adjustment and implementation of EU legislation.
The Scientific Center of Drug and Medical Technologies Expertise (SCDMTE) initiated TAIEX “Regulation of Medicines and EU Best Practices” workshop , which took place on June 28-29, 2010. During the workshop EU pharmaceutical experts Pascalino Rossi (Ministry of Health, Italy) and Jurgen Schomakher (Institute of Medicine and Medical Equipment, Germany) who were hosted by the Center presented the EU legislation on the regulation of medicine. They also discussed partnership perspectives. The experts presented European procedures for medicine registration: importance of drug safety, efficacy and quality; the order of evaluation of the information attached to the medicine; control over good manufacturing practice; decision making regarding permission or rejection of the application of medicines; the process of medicine safety monitoring; adoption of post-registration changes and other issues. These topics are required especially for the activities of the Drug Expertise Centre as Armenia has adopted a policy of introducing the best legislative experience pertaining to EU pharmaceutical industry. EU experts got acquainted with Armenia’s medicine regulation system, the processes of medicine registration, as well as GMP inspection. They provided recommendations as well. An effective medicine regulation system, as we know, protects the public health ensuring the safety, quality and efficacy of medicines available in the country. It also guarantees that they have been produced, stored and distributed adequately and that health care specialists and consumers have the required information for their justified and effective use. Naturally, consumers and physicians, as well as the state and the pharmaceutical industry have common interest in guaranteeing the effectiveness, transparency and strength of this system and that the decisions are based solely on scientific evidence. The workshop was attended by CAPS pharmaceutical cluster specialists, as well as experts from RA Ministry of Health and the Center who are involved in the above-mentioned activities. Write what you do, do what you write or If it is not documented, it does not exist
This is the approach applied in pharmaceutical manufacturing related to documentation of operations. GXP Center of Excellence in cooperation with CAPS actively proceeds with its activities aimed at the introduction of GMP standards in Armenia. The Center held a two-day training course in July, this year on documentation and Standard Operating Procedures in compliance with EU Guidelines on Good Manufacturing Standards and WHO recommendations. Documentation is essential in all stages of manufacturing to ensure compliance of production and laboratory practices with GMP requirements as well as the traceability of the whole process. Documents are also a tool for auditors to assess all activities within a company and the quality of finished products. GMP standards require documents – written procedures on absolutely all systems and actions, and this has a direct impact on the quality and safety of the pharmaceutical product. Standard Operating Procedures (SOPs) are a key constituent of a company’s system and procedure documentation. Hence, Standard Operating Procedures are the main documents for GMP inspector to make sure that the whole process of manufacturing complies with what has been written. The local trainer delivering the training presented the documentation process with practical examples focusing on the production master formula, batch records, laboratory controls, as well on the requirements for equipment qualification documentation. The discussion agenda included also such issues as writing, formulation, implementation and management of SOPs as well as their harmonization within a company. Besides, clarifications were provided on the interrelation between the documents and their control with the help of quality control system. The training focusing on the importance and application specifics of the documentation process proceeded in the format of active discussions and the best international practices in pharmaceutical manufacturing were presented to Armenian producers. Public-Private Dialogue Forum in Pharmaceutical Sector Launched On July 5-6, 2010, the Union of Armenian Medicines Producers and Importers (MPI) organized the first-ever public-private forum for Armenia’s pharmaceutical sector with the support of the Competitive Armenia Private Sector (CAPS) project. The event brought together decision makers from Armenian pharmaceutical production, import and distribution companies, as well as leaders from Government of Armenia, including the Minister of Health, Minister of Economy, Head of Customs Control Department, Deputy Director of Drug Agency of Armenia, and senior officials from the State Procurement Agency. MPI and CAPS modeled the event after the successful “Meeting without Ties” forum in the ICT industry—implemented by the Union of Information and Technology Enterprises and supported by CAPS—that allows industry participants to openly discuss issues impacting the development of the sector with key government representatives.
The adoption of European Union Good Manufacturing Practices (GMP) was one of the key topics discussed between industry participants and the Minister of Health, Harutyun Qushkyan. In particular, the industry stressed that the Government consider SME producers’ readiness when developing a timetable for GMP adoption. Minister Qushkyan stated that he was willing to visit companies individually to discuss this issue and asked MPI to prepare a timetable for these visits. Minister Qushkyan also expressed strong support for the procurement of the locally produced pharmaceuticals by the Government whenever local analogues of the required drugs are available. Finally, he encouraged local pharmaceutical producers to be more proactive and build a more active dialog with Ministry of Health. On the 2nd day, the industry met with Nerses Yeritsyan, Minister of Economy and Mr. Gevorg Saghoyan, Head of Customs Service Department. During this discussion, the industry advocated for the abolishment of value added tax (VAT) on medicines, and Minister Yeritsyan outlined the economical necessity of VAT. Director of Liqvor Pharmaceticals, Mr. Sergey Matevosyan presented the idea of a unified development strategy for the sector, which might include increasing Armenian producers’ local market share from 10 to 30-40%. Minister Yeritsyan agreed to support innovation development in sector, by developing collaboration with top international research organizations enabling research on new investigated medicines or active ingredients without large investment and laboratories development. At the Forum’s conclusion, Minister Yeritsyan expressed his appreciation for the CAPS project support to the pharmaceutical industry and expressed his great willingness to participate in next meetings and work in close collaboration with industry toward its development. Among the outcomes of the first-ever forum, includes strong interest from the representatives of internationally branded firms to collaborate closely with MPI; and increase interest by Armenian companies in joining MPI and participating in future events. We are Responsible for “Healthy Nation Healthy Economy” 
Five Armenian pharmaceutical producers have created a team together with the Union of Medicine Producers and Importers (MPI) and the GXP Center of Excellence (COE), and have, with CAPS assistance, started the execution of a campaign to increase awareness of the domestic pharmaceutical production industry and improve the perception of Armenians toward domestically-produced medicines. The campaign is founded on the introduction of EU Good Manufacturing Practice (GMP) standards by many of the production companies that will, when the standards are formally recognized by government, help to guarantee the quality of the medicines they produce. The appropriate motto for their efforts - “We are responsible for a “Healthy Nation, Healthy Economy” is therefore the slogan for this campaign. As part of the campaign, MPI and pharmaceutical producers will reveal their vision and mission within Armenia’s healthcare system to the medical community and patients/consumers. A number of different activities will be organized, including: presentations on GMP and other standards in the pharmaceutical production industry, television programs to promote important endeavors and accomplishments in the domestic pharmaceutical industry, charitable events organized by the producers and seminars on critical industry topics in Yerevan as well as in the marzes of Armenia. All the events will be publicized via the mass media. The opening event of the “Healthy Nation, Healthy Economy” Campaign, will take place on Wednesday 25th May in the Winter Garden of the Golden Tulip Hotel. The Ministry of Health, Ministry of Economy, health professionals and industry representatives will be invited to make speeches, learn about domestic producers and production, and award GMP training certificates to the 6th group of GXP COE trainees. Another Step Toward Introducing Pharmaceutical Best Practice in Armenia Armenia’s pharmaceutical industry is becoming more and more aware of concepts related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. This is a result of a continuous and systematic effort by the USAID-funded Competitive Armenian Private Sector (CAPS) Project toward introducing internationally-recognized pharmaceutical standards in the country.
Local pharmaceutical company assessments, completed by CAPS international consultants during 2008-2009, revealed the need to improve local production practices in compliance with GMP guidelines. Following the assessments, and in cooperation with government and educational institutions, internationally accredited GMP Training and Training of Trainers Courses were launched in May 2009. Since then, the locally-trained trainers shared their experience with beginners through the GXP Center of Excellence (CoE) to ensure sustainability of the program. The CoE (founded by industry stakeholders) already independently organized a series of GMP courses for pharmaceutical specialists. Feedback from participants is favorable: ‘We received an accurate understanding of how to perform workplace assessments’; ‘I have acquired in-depth awareness of the importance and methods of assessment’; ‘This has been a great opportunity to improve our knowledge on the appropriate storage and distribution of medicinal products’. Following local pharmaceutical producers requests and CAPS expert assessments on lack of validation practices in local companies, CAPS, in collaboration with the GXP CoE, in May 2010, for the first time in Armenia, held a 5-day GMP Validation course. Validation in the pharmaceutical industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to expected results. Validation is an essential part of pharmaceutical GMP standards and an important element of Quality Assurance (QA), as a tool for ensuring production consistency and compliancy. All production steps must be validated and documented in order to ensure consistent, traceable and good quality production. The training was delivered by CAPS international pharmaceutical consultants, Michael Kimber and Alain Kupferman. The core value of the course was the practical validation exercises. The course took place at the facilities of Medical Horizon pharmaceutical company and was attended by 17 pharmaceutical specialists from local pharmaceutical production companies, the Scientific Center for Drug & Medical Technology Expertise and National Institute of Health. During the course, participants learned how to develop, in practice, a validation master plan, how to identify critical processes, make risk evaluations and all other validation aspects. Based on the feedback by company specialists participating in the training course, this will help them to better prepare their companies for GMP compliance, which in turn will expand their range of markets. “The world has been led by GMP standards for more than 30 years. GMP implementation is a prerequisite for Armenian export growth and to enter the global market.” CAPS Pharmaceutical Consultant Michael Kimber said. “The industry specialists graduating from this course made another step towards introducing EU GMP principles in their businesses.” Closer to GMP Compliance 07.06.2010. CAPS international GMP (Good Manufacturing Practice) experts, Michael Kimber (Australia) and Alain Kupferman (Belgium), recently completed a GMP pre-audit evaluation for Armenian pharmaceutical producer, Medical Horizon.
The specific goals of GMP audits are to:
• Determine whether Quality Assurance, production activities and systems comply with GMP regulatory requirements and site requirements.
• Facilitate the early detection of problems.
• Help determine the depth of identified problems in the area as well as across the company.
• Investigate and determine the root causes of the problems/deficiencies.
• Assure compliance with regulatory requirements.
• Provide management with information regarding the level of compliance at the site and suppliers. According to the European Economic Area GMP Inspectors Joint Audit Program, an audit is defined as a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. In order for a company to be compliant with GMP requirements, it must successfully pass an audit. Medical Horizon pharmaceutical company was established in 2005. The factory was constructed according to GMP Standards. Production started in January 2008 with a range of syrups, suspensions and suppositories. The pre-audit evaluation covered all aspects of company production activities and provided suggestions on their further improvement, which will help the company get closer to GMP compliance and be ready for an official audit or inspection. Additionally the GMP pre-auditing process will help to build capacity in undertaking internal audits, which every manufacturer is required to conduct on a regular basis, preferably once a year. “The GMP pre-audit evaluation given by CAPS experts will greatly help our company’s development and future compliance with GMP standards, which our country will soon adopt. We will share this experience with MPI Union members.” mentioned Asbet Quassis, head of production at Medical Horizon and added “As a GXP CoE trainer, I will organize training course for industry representatives how to pass the GMP audit”. Armenian Pharmaceutical Firms strive for a ‘Healthy Nation, Healthy Economy’ 28.05.2010. A Domestic Pharmaceutical Industry Awareness Seminar was the first event to mark the commencement of a two-month “Healthy Nation, Healthy Economy” campaign initiated by the Union of Medicine Producers and Importers of Armenia (MPI) and the GXP Center of Excellence with support from the USAID-funded Competitive Armenian Private Sector (CAPS) Project.
The event, held at the Golden Tulip Hotel, hosted over 100 industry representatives including pharmacists, doctors, and GXP Center of Excellence graduates. Five pharmaceutical producers (Liqvor, Arpimed, Esculap, Yerevan Chemical Pharmaceutical Firm and Medical Horizon) presented their companies to the invited press, medical specialists and representatives of state bodies during the event. This initiative of MPI focuses on raising awareness of Armenian pharmaceutical products, their existence, availability, level of quality and competitive pricing. The director of MPI, Samvel Zakaryan, stated that approximately 300 registered and locally produced medicines undergo comprehensive quality control before reaching consumers. Medicines of local production have 8-12% domestic market share, mainly in the budget medicine market segment while 40% of total production is exported, principally to former Soviet countries, such as Russia, Ukraine, Belarus, Georgia and parts of Central Asia. CAPS Chief of Party Artak Ghazaryan highlighted the steps being undertaken to improve the quality of local pharmaceutical and medical products through upgrades in manufacturing, as well the introduction of GMP (Good Manufacturing Practice) standards. He suggested that in a few years we will be talking about local production as an export industry.
The Head of the Drug Expertise Center, Emil Gabrielyan, referred to quality assurance as the most important issue in this sphere. He emphasized positive dynamics in pharmaceutical production during the last several years, facilitated by CAPS, and the fact that pharmaceutical producers have become more unified and organized, implement joint training courses and are committed to product quality improvement and increased public awareness. The abovementioned factors inspire hope for the development of Armenia’s pharmaceutical production as a competitive and powerful economic lever with the introduction of best international practice. The RA Deputy Minister of Economy, Ara Petrosyan, stated that the annual pharmaceutical manufacturing turnover for 2009 amounted to 2.5 billion AMD with an 8.8% increase compared to the previous year. This is a good indicator, especially for a crisis year. Meanwhile, the industry’s progress for this year is significant with an 18.5% growth rate during the first quarter alone. The ceremony ended with the award of certificates to the sixth group of graduates from the GXP Center of Excellence; a leader in vocational training and the introduction of quality standards in the pharmaceutical industry. The initiatives of pharmaceutical producers attracted the interest of mass media representatives. The Domestic Pharmaceutical Industry Awareness Seminar was widely covered by the print media (Azg, Capital, Aravot), TV and radio (H1 – ‘Haylur’, ’Haylur-Index’, H2- ’Lraber’, AR – ’Azdarar’, Kentron – ’Epikentron’, Shant TV, Armnews, TV 5, Public Radio – ‘Radiolur’ etc.) and online media. During the campaign, Armenian pharmaceutical producers will present themselves and the MPI union through various TV programs, advertisements, cross-country visits and charitable events. One of the producers already organized a charitable event at one of Nubarashen’s schools in celebration of Children’s Day. MPI also organized a press conference and round-table discussion on TV presenting Armenian pharmaceutical companies and their development issues to the general public. During the summer, the MPI Union, with CAPS support, will commence a summer school for pharmaceutical students, enabling them to become more informed on local pharmaceutical production. CAPS international expert Frans Stobbelaar will also lead a workshop on ethical marketing practices. Armenian pharmaceutical producers are particularly interested in this issue and are willing to introduce principles of fair marketing practice for medicine distribution in Armenia. Marketing Best Practices to Help Pharmaceutical Companies Increase Domestic Sales and Access New Markets .jpg) 07.05.2010. The Competitive Armenian Private Sector (CAPS) project is working with the Armenia’s pharmaceutical industry to capture a larger share of the domestic market and target new international markets. In 2010, CAPS hired Gerrit ten Hoonte, an International Pharmaceutical Marketing Expert, to evaluate the pharmaceutical industry’s potential to expand both domestic and international sales, and to conduct international marketing training course for companies.
With Mr. Hoonte’s support, the MPI Union and medicine producers launched a communications campaign to increase the awareness and improve perception of Armenian pharmaceutical producers in the local market-a constraint that impacts domestic sales as indentified in the CAPS-supported survey in 2009. Companies will showcase their production and explain advantages of the local production compare to imported equivalents, as well as organize charitable events to build trust among the consumers. In May, the first “Recognize Armenian Pharmaceutical Production” event marked the commencement of the awareness campaign that will run through August. In the short-term there is significant potential to increase domestic sales, but in the long-term Armenian pharmaceutical producers will need to increase exports to remain competitive and increase sales, as local production capacity is larger than domestic market demand. CAPS is working with these producers to receive European Union Good Manufacturing Practice (GMP) certification, which allow the companies to export EU markets. However, the EU markets are highly competitive markets and the firms will need to upgrade their marketing and promotion capacity in order to target customers in the EU and other markets. During a first visit, Gerrit ten Hoote conducted a training course for companies on export market penetration, new leads generation and product presentations relevant. Mr. Hoonte also conducted one-on-one consultations with the companies to provide advice on marketing, developing export strategies, positioning their products, identifying purchase decision makers and applying appropriate promotional activities. Mr. Hoonte mentioned that every pharmaceutical product requires individual approach in marketing and promotional strategy development. During his most recent visit, Gerrit ten Hoonte observed that the pharmaceutical producers were already applying many of his recommendations from the course and one-on-one consultancies. Transferring Western Knowledge to Armenia:
Yerevan State Medical University and University of Southern California Sign Academic Partnership Agreement  March 29, 2010, Yerevan, Armenia. A tripartite agreement establishing an academic partnership between Yerevan State Medical University (YSMU) and the University of Southern California (USC) was signed today between the two universities and the USAID-funded Competitive Armenian Private Sector (CAPS) Project.
The initiative aims to upgrade and re-align pharmaceutical curricula to better respond to the employer market, instill modern teaching methods and form long-term professional relationships; transferring knowledge from western institutions to those in Armenia. Developing linkages between U.S. and Armenian Universities will help improve the overall quality of pharmaceutical education in Armenia. More than 20 faculty members, students, as well as guests from USAID attended the agreement signing ceremony, which was followed by presentations by the YSMU and USC representatives. Opening the event, YSMU Vice-Rector of Professional and Continuing Education, Dr. Gevorg Yaghjyan, attached importance to this initiative and expressed belief that it will contribute to the development and implementation of the Master’s program in Pharmacy. In his remarks, Michael Wincor, Associate Dean, Globalization and Continuing Professional Development and Associate Professor of Clinical Pharmacy at the USC School of Pharmacy and Medicine, noted that cooperation between the two universities will undoubtedly yield tangible results. “Many Armenians live in the United States, especially in California, and the agreement, which aims to focus on the problems that exist in this sphere, will help expand the labor market” he said. In the context of the partnership agreement, Dr. Wincor will conduct a needs assessment of the program on this trip and undertake a review and evaluation of course offerings in the existing Master’s Program in Pharmacy. “By developing university partnerships between Armenian and world-renowned educational institutions CAPS intends to improve education curricula and training methods and align workforce development efforts with evolving market requirements” Artak Ghazaryan, CAPS Chief of Party noted. Since the beginning of 2009, four university partnerships have been established with CAPS efforts designed to provide world-standard curricula with training of trainers and sustainability. These include: Virginia Polytechnic Institute and Armenian Greek College of Food, Industry and Tourism in the tourism sector; George Washington University and the American University of Armenia for Tourism Destination Management; Virginia Tech and Russian-Armenian (Slavonic) State University for IT; and the YSMU and USC for pharmaceuticals. Improving Knowledge Base On Pharmaceutical Quality Assurance On December 4 and 5, CAPS implemented a course on EU Guidelines of Good Distribution Practice for Medicinal Products. The training, conducted in collaboration with the newly established GXP Center of Excellence, was led by international consultant Dr. Michael Kimber. Twenty-two representatives of Armenian drug manufacturing and distributor companies, the Scientific Center for Drug and Medical Technology Expertise, the Ministry of Health and the National Institute of Health took part in the training. The course aimed to build capacity within individual companies to establish a distribution and supply chain quality assurance system in order that patients receive quality medicines, in compliance with EU GDP requirements.
On December 9-11, Michael Kimber conducted a course on GMP Workplace Assessments. Twelve participants of the GMP Training course, implemented in May-June 2009, took part in the training, intended to create a core group of assessors capable of assessing in-company GMP training courses and trainers. The GMP Trainers will develop their own in-house training programs and assessment documents, based upon standardized criteria. Feedback from course participants was favorable: ‘We have received an accurate understanding of how to perform workplace assessments’; ‘I have got in-depth awareness of the importance and methods of assessment’; ‘This has been a great chance to improve our knowledge of the right organization of storage and distribution of medicinal products and of making the right decision in extreme situations’. The newly created GXP Center of Excellence (CoE) acted as a partner in organizing both training courses, namely, in the promotion, recruitment and selection of participants. Both courses contributed to an improved knowledge base on pharmaceutical quality assurance and enhanced capacity of the CoE, established with CAPS assistance. 2nd Armenian Pharmaceutical Competitiveness Conference Kicks off in Yerevan December 2, 2009. Armenia’s second Pharmaceutical Competitiveness Conference was held in Yerevan on yesterday on the initiative of the USAID-funded Competitive Armenian Private Sector (CAPS) Project in partnership with the RA Government, the Scientific Center of Drug and Medical Technology Expertise (SCDMTE), the Union of Medicine Producers and Importers of Armenia, Armenian Development Agency, and National Competitiveness Foundation.
The event updated industry representatives on the current status of the sector, promoted collaboration among pharmaceutical sector stakeholders, and encouraged discussions on major industry issues, including financial crisis impact on pharmaceutical production, adoption of international industry standards and export market opportunities. Around 200 participants representing government, the private sector, educational institutions, international organizations and business associations attended and discussed various important issues, including: opportunities for Armenian pharmaceutical producers in domestic and foreign markets, the need for improvements in medicine regulation, the current situation of medicine production in Armenia and possible development scenarios, etc. Opening the conference, Ara Babloyan, Chairman of the Standing Committee on Healthcare of the National Assembly, praised the efforts of the conference organizers and highlighted the importance of raising issues requiring legislative solutions. “Broad discussions like this will provide an excellent opportunity to analyze the weaknesses and the challenges that can be overcome in future. A sound legislative filed will create favorable conditions for medicine circulation” he added. David Hull, Director of the Economic Growth Office, USAID/Armenia said. “USAID attaches importance to the assistance being provided to the Armenian pharmaceutical industry because domestically produced drugs significantly contribute to the availability and affordability of major drugs. Under the CAPS Project, assistance is being provided to bring the sector in line with international standards, which will also help enhance the sector's competitiveness and promote exports.” Other keynote speakers included Emil Gabrielyan, Director of SCDMTE who highlighted the issues related with implementation of Good Manufacturing Practice (GMP) international standard in Armenia and Artak Ghazaryan, CAPS Chief of Party. The conference built upon the success of the first Pharmaceutical Competitiveness Conference, held last November by CAPS and its major partners in the pharmaceutical industry. That conference focused on introducing Good Manufacturing Practice (GMP) standards. CAPS Helps Armenian Medicine Producers Enhance Marketing Skills- Training on Pharmaceutical Marketing Opens in Yerevan October 15, 2009. Training on Pharmaceutical Marketing for Armenian pharmaceutical industry opened today in Yerevan. The five-day training program is jointly organized by the USAID-funded Competitive Armenian Private Sector (CAPS) Project and the GXP Center of Excellence, recently established with CAPS support through the Union of Medicine Producers and Importers of Armenia (MPI). The initiative aims to assist Armenian medicine producers in enhancing their production efficiency and increasing the visibility of Armenian-produced drugs in the local and export markets.
Local producers currently only satisfy around 10% of domestic demand. CAPS research on the domestic perception of drugs produced by Armenian pharmaceutical companies has revealed that these medicines do not command a particularly strong image domestically; interviewees typically believe that imported drugs are of a higher quality. This is also partly conditioned by poor marketing activities on the part of the producers. The survey results suggest that Armenian pharmaceutical producers work hard on their marketing, particularly focusing on the medical profession, to change perception about Armenian-produced drugs. Whilst many of the pharmaceutical manufacturers would like to diversify their product portfolio into current markets and expand the range of export markets, companies have limited knowledge and information about potential markets. Taking into consideration the lack of marketing knowledge and ability to market effectively in both the domestic and export markets, the organizers of the training have specifically tailored the basic marketing course toward the pharmaceutical industry. The course is being delivered by Gerrit ten Hoonte, an international expert with over 30 years experience in pharmaceutical marketing. Participants include company representatives, business service providers, civil servants, MPI representatives and academia. “The domestic market is too small for local producers from the point of view of product realization, and in order to expand toward export markets they need to master essential marketing techniques. The training provides an excellent opportunity for participants to familiarize themselves with the peculiarities of export marketing.” Lala Margaryants, CAPS Pharmaceutical Cluster Coordinator stated. The training will be supported by one-on-one assistance to each pharmaceutical company, with a more advanced marketing course to follow. Pharmaceutical Training on Quality Standards Launched .jpg) Training entitled “EU Guidelines on GMP (Good Manufacturing Practice) for Pharmaceutical Production” was launched in Yerevan today as a joint initiative of the USAID-funded Competitive Armenian, Private Sector (CAPS) Project and the recently established GXP Center of Excellence. The training course aims to enrich the knowledge of industry specialists on EU GMP requirements. Twelve representatives of medicine-producing companies are participating on the training course; delivered by internationally-qualified Armenian GMP expert-trainers.
Armenia’s pharmaceutical cluster is making remarkable steps towards the introduction of GMP, a quality standard that most countries rely on today to import or produce medicines. In Armenia, however, as CAPS assessments amongst pharmaceutical companies have revealed, GMP knowledge appears to be deficient in a number of areas. Taking this into consideration, and, studying and assessing the Armenian pharmaceutical producers, CAPS international consultants Michael Kimber and Alain Kupferman developed a GMP training course in 2008, based on the World Health Organization’s basic and advanced GMP Training Modules, and adapted them to meet the Armenian situation. The training course was approved by the RA Minister of Health. The first “EU Guidelines on GMP for Pharmaceutical Production” course was delivered by Kimber and Kupferman in May-June 2009 for local producers, academic staff and business service providers. It was then followed by a “GMP Training of Trainers” course. Today, four of the 17 locally-trained trainers share their experience with beginners through the GXP Center of Excellence (founded by industry stakeholders) to ensure the sustainability of the program. During his speech at the opening of the course, Artak Ghazaryan, CAPS Chief of Party highlighted the importance of introducing high quality standards in the Armenian pharmaceutical industry and expressed hope that participants will apply the new skills and knowledge in practice. “The CAPS project is ready to assist projects that promote cooperation among stakeholders” he added. Internationally Recognized Pharmaceutical Training Program Launches in Armenia  An internationally-recognized GMP (Good Manufacturing Practice) Standards Workshop and Training of Trainers program for Armenia’s pharmaceutical industry was launched today. The program is a joint initiative of the CAPS project, the Ministry of Health, Scientific Center for Drug and Medical Technology Expertise, Yerevan State Medical University and the newly established GXP Centre of Excellence. Facilitated by international experts, the program aims to standardize knowledge of EU GMP requirements amongst a core group of pharmaceutical cluster representatives, as well as to strengthen the capacity of academic institutions to provide training in GMP.
Opening the workshop, Hayley Alexander, CAPS Chief of Party highlighted the importance of introducing GMP in Armenia. “This intensive course is intended to bring the Armenian pharmaceutical industry in line with the international practice and is probably the most important step the Armenian pharmaceutical industry can take now. GMP certification is no longer optional for export; moreover, GMP implementation can help overcome another obstacle - the quality perception problem in the domestic market. The Armenian Pharmaceutical Industry is making dramatic steps toward the introduction of GMP, a quality standard that most countries in the world rely on today to import and export medicines. Assessments undertaken amongst Armenian pharmaceutical companies, however, have revealed that GMP knowledge appears to be deficient in a number of areas. “Compliance to GMP international standards is important for the Armenian pharmaceutical industry. Without that standard Armenia will never become a pharmaceutical production center”. Emil Gabrielyan, Director of Scientific Center for Drug and Medical Technology Expertise stated. In his remarks, Rolf Anderson, Head of Economic Growth Office of USAID praised the collaborative efforts of the workshop organizers expressing commitment on the part of the US government to further support pharmaceutical sector development programs in Armenia. The 13-day, comprehensive, advanced-level training program is specially designed to address the abovementioned issues. The workshop is targeted at pharmaceutical production company quality assurance managers, in-company trainers, technical managers, and senior supervisors. After studying the specific problems and needs of the Armenian Pharmaceutical Sector, CAPS consultants have developed a GMP Training course based on World Health Organization GMP basic and supplementary training modules, and specifically tailored them toward EU nuances and requirements for use in Armenia. An additional course will assist trainees to become GMP trainers. Then those who successfully complete the Advanced GMP and Training of Trainers courses will be eligible to provide training through the GXP Center of Excellence, which has been established in May of this year by the Union of Medicine Producers and Importers through CAPS assistance. The GXP Center of Excellence will deliver sustainable, fee-based certified training programs and assist companies to fulfill their continuous training needs. Improving Domestic Perception of Armenian Pharmaceuticals  April 16, 2009. CAPS research undertaken last year on the Domestic Perception of Armenian Pharmaceutical Products which surveyed consumers, clinic representatives (pharmaceuticals procurers and physicians) and pharmacy representatives (managers or owners and pharmacists), revealed an ambiguous attitude of consumers toward Armenian pharmaceuticals.
A workshop held on 16th of April addressed the aforementioned conclusions in order to develop strategies for improving the domestic perception of Armenian pharmaceutical products. CAPS pharmaceutical consultant, Frans Stobbelaar, presented in more detail the strengths and weaknesses of the Armenian pharmaceutical industry vis-à-vis the five identified target groups, and suggested approaches to address the weaknesses and build upon the strengths. The participants (Liqvour, Medical Horizon, Esculap, Vitamax-E and Arpimed, the Union of Medicine Producers and Importers (MPI), the Armenian Pharmaceutical Association (APA), the Scientific Center for Drug & Medical Technology Expertise, representatives from pharmacies and AM Partners consulting company) actively participated in formulating the strategy points containing elements for the industry as a whole (collective action), for the individual companies and also issues that need to be taken up by the public sector (Ministry of Health). Discussion points included quality image, company positioning, market strategy, supply chain management, government tenders, communication and training. Companies were suggested to do “homework” determining their strong and weak points and further develop their target groups and promotional activities. CAPS Participation At Health Service and Pharmacy EXPO April 15, 2009. The Health Service and Pharmacy Expo 2009, was held from April 10th to 13th at Moscow House, Yerevan. Participants of the exposition included the Ministry of Health, pharmaceutical associations, local and foreign medicine producers and medical equipment suppliers.
USAID also represented its programs in the health and pharmaceutical sector. These comprised the Armenian Eye Care Project, NOVA Reproductive Health Project, Primary Healthcare Reform Project, Medical Outreach Teams Project, Human & Institutional Capacity Development Project and CAPS; focusing on Pharmaceutical Cluster Development. Assistance provided to the Armenian-American Wellness Center and National Tuberculosis Program was also highlighted at the Stand. CAPS presented its activities aimed at development of a competitive Armenian pharmaceutical cluster. Exposition participants were informed about activities in the Armenian pharmaceutical sector and CAPS support to them. During the exposition, CAPS presented its Pharmaceutical Investment Guidebook, a special issue of its Armenian Competitiveness Newsletter dedicated to the pharmaceutical industry, results of an Assessment of Skills and Knowledge Needs for the Pharmaceutical Industry and a part-funded Bulletin of the Medical Institute after G.Mehrabyan. CAPS also supported the Medical Producers and Importers (MPI) Union to organize a round table discussion focused on the promotion of local pharmaceutical production and the role and aims of MPI Union in the development of local production. CAPS Supports MPI in Increasing Awareness of Armenian Pharmaceutical Products Among Consumers  April 14, 2009. The eighth international "Health Service & Pharmacy 2009" exhibition took place between April 10 and 13 at the “Moscow House” in Yerevan. The event was organized for medical centers, investors, entrepreneurs, as well as for those involved in the medical products and services market. The Union of Medicine Producers and Importers (MPI),one of Armenia’s major professional pharmaceutical industry associations, was among the 50 exhibitors and was particularly promoting domestic products and producers to buyers and members of the medical and retail pharmaceutical industry.
Within the framework of its initiative to enhance the competitiveness of Armenian pharmaceuticals, CAPS supported the MPI Union in preparing for the exhibition. With CAPS assistance, the Union prepared a presentation to the healthcare industry, pharmacists, doctors and producers about the “Present and Future of the Pharmaceutical industry”. The presentation took place on April 10 among 30 participants from the pharmaceutical industry and press. Tatul Hakobyan, RA Deputy Minister of Health led discussions that focused on VAT exemption issues, drug registration transparency, and awareness of Armenian pharmaceutical products among consumers.
“Armenia is largely dependent on imported medicine, since domestic production only represents 10% of the country’s total medicine turnover. However, research shows that medicines of Armenian origin are no worse in quality than their foreign analogues. Moreover, 40% of the domestic medicine production is exported to CIS countries. It is impossible to export poor quality medicine.” Armen Aghayants, President of the MPI Union stated. Strategic Plan Development for Medicine Producers and Importers Union of Armenia April 10, 2009. With CAPS local STTA support, the Armenian Union of Medicine Producers and Importers (MPI) has completed its first, 3 year Strategic Plan, and in addition, a Business Plan for establishing a Good Manufacturing Practice (GMP) Center of Excellence in Armenia.
According to the Strategic Plan, MPI Strategic directions for the next 3 years will be to improve service delivery capacity of the Association; intensify the dialog with Government to improve the policy and regulatory environment; help members to access new markets, increase the membership, and intensify relationships with the business support community. MPI also formed a Working Group to address the establishment of a GMP Center of Excellence and as a first step, developed a business plan to address the key issues for establishment of the Center. The Center of Excellence is planned to provide training courses on GMP to Armenian pharmaceutical producers. The training of GMP trainers will be conducted by CAPS international consultants, after which the new Center will provide services to local companies. After the Center of Excellence is established, MPI will continue developing the capacity of the training center to deliver courses in other areas as well: Good Distribution Practice (GDP), Good Laboratory Practice (GLP) and other disciplines as demanded by the pharmaceutical industry.
Assessment of skills and Knowledge Needs for Pharmaceutical Industry
In support of one of its major goals – to bridge the gap between the skills acquired in higher education and the needs of employers – CAPS undertook a needs assessment among pharmaceutical firms and academic institutions. The purpose of the assessment was to identify gaps between what skills and knowledge exist and are required within the pharmaceutical sector. Specifically, the assessment sought to identify the skills, knowledge and competencies as well as training needs of the pharmaceutical workforce.
The initiative, conducted by AM Partners Consulting Company (Armenia), resulted in a complete Skills and Knowledge Needs Assessment report with job classification and job description templates developed based on international best practice. The survey covered nine leading pharmaceutical production companies and revealed some interesting findings. Clearly, a number of Armenian pharmaceutical producers need to improve their internal structures and the manner in which staff are developed professionally. Some managers would like to improve the qualification of all employees; others prefer to train only some specific specialists. Assessed companies stated that specialists' knowledge is not up-to-date and production operators are not completely aware of the capacity of modern equipment. Hence, they are in need of training to improve their skills. It was also stated that there is a general lack of qualified personnel in Armenia. Managers declared that their personnel need to receive up-to-date training on Good Manufacturing (GMP), other practices (GXP), and other professional issues. The study proved conclusively that cooperation between the pharmaceutical producers and educational institutions, who are supposed to be turning out a future workforce, is remarkably limited. Producers are demanding closer cooperation from educational institutions. Managers of enterprises are dissatisfied with the current educational system and suggest immediate changes to it, whereas educational institutions are confident that current curricula and disciplines fully meet requirements. This situation obviously indicates a rather significant disconnect and one which needs to be rectified.
The presentation of the Assessment findings was conducted on February 20, 2009 at the CAPS office. Representatives of educational institutions offering pharmaceutical programs, companies, and pharmaceutical associations were present at the session, which was followed by a lively discussion among the participants. Participants agreed a training center is needed to provide up-to-date GMP and GXP knowledge to current and future employees in the pharmaceutical sector. Although representatives of state educational institutions declared their curricula and course offerings to be up-to-date, and the reason for producers' dissatisfaction related to other issues, further assessment of educational institutions' curricula (both state and private) should be completed in order to objectively represent the current situation in this area.Additionally, CAPS will continue to develop and use strategies to address identified gaps and shortcomings. Presentation on the Pharmaceuticals Sector Skills and Knowledge Needs Assessment The results of the Pharmaceuticals Sector Skills and Knowledge Needs Assessment will be publicized on February 20, 2009. This assessment was undertaken by AM Partners with funding provided by a CAPS grant. The report includes an assessment of the skills, knowledge and competency gaps and a classification of typical jobs within Armenia’s pharmaceutical industry relative to international best practices. It also prioritizes next steps for curriculum development and training required for higher and vocational education institutions faculty. The targeted audience includes Rectors and Deans of universities with the largest share of pharmaceutical graduates, pharmaceutical companies, the Ministry of Health, the Ministry of Education and Science, and other groups concerned with the development of Armenia’s pharmaceutical industry. One Step Closer To GMP ComplianceFollowing the successful Pharmaceutical Conference held on 12th and 13th November, CAPS consultants, Frans Stobbelaar, Michael Kimber and Alain Kupferman provided technical assistance to individual pharmaceutical manufacturing companies, advising on critical steps for Good Manufacturing Practice (GMP) compliance. Although the date has not yet been set, the Government of Armenia has committed itself to adopt legislation and will soon require all manufacturers to meet GMP standards. The advice provided by the CAPS consultants aimed to assess the current level of theoretical compliance and highlight critical areas each company must focus on to meet these GMP standards once the inspectorate is established through legislation. Many of the company visits were accompanied by GMP specialists from the Scientific Center for Drug & Medical Technology Expertise, who were able to gain an understanding of the challenges faced by the individual firms. The results of the company assessments have been provided to the Ministry of Health in order for them to assist Armenian pharmaceutical producers by adopting a realistic timeframe for GMP compliance. Detailed reports have also been provided to the individual companies. CAPS anticipates providing further assistance to companies, either directly or facilitating contacts with other experts in the pharmaceuticals field. Armenia's First Pharmaceutical Industry Conference Introduces International Standards Awareness of internationally recognized Good Manufacturing Practice A(GMP) Standards was the main topic of Armenia's First Pharmaceutical Development Conference held on November 12-13, which brought together industry representatives to discuss urgent issues. Key Armenian pharmaceutical producers, government representatives, business associations, university lecturers, graduates and donor organizations came to express and hear expert opinions to make Armenia's pharmaceutical industry more competitive. The conference moderator, Deputy Minister of Health Tatul Hakobyan, emphasized the importance of collaboration between the private sector and the public sector in improving the quality of medicines in Armenia. “To achieve the improved quality objective adequate contemporary regulations must be paired with investments and training” he said. Talking at the opening of the conference, Rolf Anderson, Head of the Economic Growth Office at USAID, said that Armenia's pharmaceutical industry has inspiring potential to develop. “However, it is important that Armenia introduces quality standards to ensure further successful development” he added.
The conference addressed the basic principles of GMP, an internationally recognized quality standard ensuring quality pharmaceutical production. Today, most countries only accept imports of medicines that are in compliance with GMP requirements. The industry experts assert that medicine produced in Armenia should also meet GMP requirements in order to compete internationally. The two-day conference also raised education, workforce, cluster development, advocacy and policy issues within the pharmaceutical industry. The event was organized with collaborative efforts of the industry stakeholders, including: CAPS; the Government of Armenia; MPI (the main business association of the pharmaceutical industry); World Health Organization; and the Scientific Center of Drug and Medical Technology Expertise (National Drug Agency). As a result of the conference, the Government of Armenia committed itself to adopt legislation and will soon require all manufacturers to meet GMP standards. Following the conference, CAPS consultants, Frans Stobbelaar, Michael Kimber and Alain Kupferman conducted GMP assessments of individual pharmaceutical manufacturing companies providing them technical assistance on critical steps for GMP compliance. The results of the company assessments have been provided to the Ministry of Health in order for them to assist Armenian pharmaceutical producers by adopting a realistic timeframe for GMP compliance. Detailed reports have also been provided to the individual companies.
Marketing and Promotional Assistance to the Union of Medical Producers & ImportersCAPS has commenced a marketing project to assist Armenia’s Pharmaceutical Industry in improving its image within the community of doctors, clinics and pharmacies. CAPS has awarded Eresunhing Millimetre Ltd, a local business service provider, to undertake the project. The project includes the design, filming, copy creation, editing, translation, hosting and publication of various promotional materials and gifts, particularly an industry brochure, association brochure, banners, desk calendars, Union website and promotional DVD. Most of the marketing materials are for the Union of Medicine Producers and Importers’ (MPI) participation at the Human Health Congress being held on November 5-7, 2008. This will be the first attendance of the MPI at such an event. MPI will present all members under one umbrella in a single booth, and will distribute promotional materials that raise the awareness and perception of the local pharmaceutical industry and its member producers. | 
