Application Of Uniform Quality Management Principles In European Medicines Agencies Emphasized In Riga Meeting

The 2 to 3 June 2015 meeting of the Heads of Medicines Agencies (HMA) Working Group of Quality Managers (WGQM) took place in Riga, Latvia. The agenda of the meeting included the implementation and ensure the uniform principles of quality management in the European Medicines Agencies.



Participants of the meeting - those responsible for quality of national medicines agencies in the countries of the European Economic Area and representatives of the European Commission and the European Medicines Agency - discussed the following topics: implementation of mitigation guidelines on conflict of interest ensuring the risk management approach in the national medicines agencies and the results of benchmarking (comparison of an entity (company or other organization) to others and learn from the results of this comparison). Future activities for the next assessment cycle is also planned. Quality managers of the European Medicines Agencies exchanged examples of good practices in quality management, which is an important contribution to increased operational improvement of medicines agencies. Ms. Caitriona Fisher, Manager of the Office of the Chief Executive and Chief Quality Healthcare Products Regulatory Authority of Ireland, was re-elected as head of the Working Group for the next three years.

WGQM is the working group established by HMA whose main task is to support the quality management system European drug regulatory framework for public and animal health. The meetings are held every six months WGQM Drug Administration current Presidency of the Council of the European Union.

China Stock Jump Blows Up Bond Yields in Threat to PBOC

Beating China Surge stock world is sucking money away from bonds and thwart the efforts of central banks to reduce borrowing costs to support the economy.

Yields yuan corporate notes of five with the highest scores jumped 30 basis points last month to 4.74 percent, the highest in nearly December. The Shanghai Composite Index, the benchmark for the biggest stock market in China, jumped 24 percent in the same period, the most among the major stock indicators worldwide.

People's Bank of two interest rate cuts in China since November prompted the rally actions even if they have not been able to reduce business financing costs or mitigate the debt repayment difficulties. Live coverage Technology Group Co. became the second company to default on the China onshore bond market last week amid the weakest economic growth since 1990, while Kaisa Group Holdings Ltd missed interest payments after was involved in a corruption investigation.

"With the stock market works so well, it's more natural funds choose to invest in stocks instead of bonds, which resulted in the lack of investor demand for new bonds and thus higher yields" said Li Zhang, a credit analyst with Beijing-based Guotai Junan Securities. "Due to the high performance required, some issuers shot deals."

Call For Fairness:

Guangdong Roads & Bridges Construction Development Co. delayed 2 billion yuan (322 million) bond issue, which was originally scheduled for April 2, citing major market fluctuations, according to a company statement on the website of ChinaBond.

Companies raised 205 billion yuan of domestic investors through IPOs in China in the first two months of the year, double the same period of 2014, according to the China Securities Regulatory Commission. The bond rose just 7 percent to 581.6 billion yuan, the site data show China Bond.

"It's safe to assume when more funds go to market shares, end up with fewer obligations," said Liu Dongliang, senior bond analyst at China Merchants Bank in Shanghai. "We have noticed more funds have been established to invest in equity and banks were selling more wealth management products that use stocks as underlying asset."

The jump in stocks in Shanghai pushed revenues give up only 0.08 percentage points higher than for the best corporate notes due in 10 years Wednesday, making it more expensive hand over bonds since 2010.

Shifting assets:

As investors turn to riskier assets, the return of sovereign benchmark bond jumped to 10 years for seven consecutive weeks to Friday, the longest series of increases in Bloomberg data going back to 2007. It is now to 3.62 percent, near its highest in four months. The yield as maturity of AAA corporate securities is 4.89 percent, after touching a high of five percent three months March 31.

"Chinese Government Bonds and notes with high marks seen the biggest drop in prices because yields of these notes can not cover the cost of funds for many investors," said Zhang Guotai Junan. "In addition, there have been many high-quality bonds offer recently and it is likely to continue in the short term which is also a pressure on prices."

Offers the best rated debt are likely to flood the market that China encourages municipal authorities to sell bonds directly, rather than through local government financing vehicles. Local authorities will issue at least 1.6 billion yuan debt this year, quadrupling from 2014, according to the Ministry of Finance estimates Mars.

Big Problem:

More money will probably flow into the actions that the government encourage the financing by selling shares, said Gao Qunshan, credit chief analyst at Industrial Securities in Shanghai. PBOC Governor Zhou Xiaochuan said in companies seeking funding through March the stock market can help the economy.

The Chinese economy has slowed the pace of the weakest expansion since 2009 last quarter that decision makers to implement a reform program while mitigating targeted stimulus to growth. Gross domestic product grew 7 percent in the three months to March from a year earlier, the statistics bureau said in Beijing Wednesday,

"This is a big problem that the actual borrowing costs are yet to come down after the rate cuts," Gao Industrial Securities said. "We expect the government to come out with more policies against this problem. The whole market is watching."

AIR POLLUTION EMERGENCY RESPONSE MANAGEMENT : THE 10TH CHINA CITY AIR QUALITY MANAGEMENT WORKSHOP

The 10th China City Air Quality Management Workshop: Air pollution Emergency Response Management

The theme of managing emergency response air pollution of the eleventh city management workshop air quality was held 24 to June 25, 2014 in Beijing, which was co-organized by the Ministry of Foreign Affairs Economic Cooperation (FECO) of the Ministry of Environmental Protection of China (MEP) and Clean Air Asia (CAA), with the support of the Energy Foundation of China. The objective of the workshop was to support implementation of the Plan of Action of Air Pollution Prevention and Control of revising the Law of PRC on the Prevention and Control of Atmospheric Pollution and city pollution Air management emergency response. Eighty participants attended the workshop, including officials from MEP, Environmental Protection Agency (US EPA) and the National Environment Agency of Singapore (NEA), representatives of 20 provinces and cities, and experts from universities and research institutions.

Mme. Li Pei, Deputy Director General of FECO hosted the opening ceremony and delivered the keynote address. He expressed welcome and thanks to all participants and collaborators. She introduced the background of the workshop and noted the positive role that previous nine workshops Quality Management China Air City have played in promoting exchange of experiences and improving cities'capacities on prevention and control of air pollution.

 Mr. Yan Jingjun, Deputy Director General, Center for Environmental Emergency and Accident Investigation MEP said the thematic workshop on emergency management, air pollution is very timely and relevant; He also called for a more proactive response to deal with heavy air pollution in the future. 

Mr. Lu Shize, Director, Air Division, Department of Control of Pollution Prevention, MEP presented the progress and priorities of their work since the publication of the prevention of air pollution and Control Action Plan in September 2013, and stressed the importance of emergency response air pollution. Zhao Lijian, Program Director of Environmental Management, Energy Foundation of China, said the human, material and financial resources are necessary input for the prevention and control of air pollution and spread the will to carry out a increased cooperation with the FECO and CAA to provide provinces and cities in China with international experiences and practices. Dr. Fu Lu, Director of China in CAA expressed his sincere thanks to the members, sponsors, experts and representatives of provincial and municipal levels. 

She said CAA will keep providing cities with technical support and a platform for the exchange of experiences and communication in the management of air quality in cities; She also invited guests and representatives joining the Better Air Quality Conference (BAQ 2014) from 19 to 21 November 2014 in Sri Lanka.

Expectations For Quality Management Systems Of Vietnam

In 2010, Prime Minister of Vietnam signed a decision to improve the quality of Vietnamese goods and products in 2020 to promote quality products Vietnam when integrated into the global market economy. At present, the quality of Vietnamese products is evaluated on the basis of management systems advanced US and the EU, such as ISO 9000, ISO 14000, TMQ, GMP, HACCP Q.base and which are recognized in global markets. However, the history of quality management of businesses remains controversial.

Will ISO ISO certified companies manufacture products?

ISO-certified companies find all the ways to demonstrate that they have the ISO certification. Some companies are trying to emphasize that their products are certified as ISO products to make an impression with consumers. What few know is that the ISO certificate does not give any specific product, but it is for companies or parts of companies with a quality management system in accordance with the requirements of the international standard ISO 9001: 2000 (or ISO 9001: 2008 ). And, of course, despite being ISO certified companies, products manufactured by enterprises technological chains in the US, Japan and Europe have different quality of products manufactured by the production lines in China.

 

In the context of quality Vietnamese products are the problems that face consumers and manufacturers, the ISO system does not meet the expectations of many business owners; certificates are only passports to help companies comply with the basic mandatory requirements by some foreign partners or qualifications to brag to customers, rather than a determination confirmed to maintain and pursue quality to meet the real needs. Many ISO documents have been prepared only to meet the requirements of "essential" but not to increase the efficiency and effectiveness of business; business owners do not pay adequate attention to ISO and ISO certificates are considered jewels of public affairs rather than an internal solution to improve the performance of organizations.

According Pho Duc Son, Director of Quality and Standard Institute Vietnam, many companies do not adequately understand about the ISO so I put too many expectations on the ISO and then are disappointed. ISO is not a magic wand that can solve all the problems of management activities of production and business activities, or business operation and in general.

The ISO only give general instructions for a quality management system requirements to help businesses gain the ability to offer products with stable quality and meet customer needs and legal requirements, including regulations under the Act rather a comprehensive solution covering all important business issues such vision, mission, objectives, strategic direction and corporate strategy, business strategy, organizational structure, management principles and operation, performance, and other problems in humans, the environment and corporate culture.

Even when manufactured products meet quality requirements, there is no guarantee that the product will sell well unless the company adopts brand and effective marketing plans and aftermarket services. Not all companies with ISO certification are equipped with sufficient elements to manage a business management system.

The ISO alone cannot help turn a weak business with many problems in an efficient business.

Nguyen Manh Hung, Vice President and Secretary General of Standards and Consumer Association of Vietnam (VINASTAS) said that there should be more forums to assess the effects of actual construction and implementation of ISO in Vietnamese companies, as lead out on forums about the corporate culture and brand building. If the solution does not bring effective results for businesses, we have to re-evaluate the use of solution providers or solutions.

Standards Generalization Of Vietnamese Products

The facts show that the number of Vietnamese goods does not meet customer demand; according to the Consumers Association, the Vietnamese market is delicious cake for foreign retailers, growth in imported into Vietnam for 5 years average goods increased by 21.3 percent per year. This shows that Vietnamese goods has not complied with its customers.

According to Nguyen Manh Hung, Vietnamese producers have to think about improving the quality of internal product instead of worrying about the market share that will be occupied by foreign producers. More importantly, how are national companies produce better quality products with most competitive prices? How can you meet the criteria of "Vietnam products have high quality"?

For a long time, Chinese products have been prevailing on the market; many items are imported from Vietnam, like toothpicks, wipes, plastic toys, clothing, footwear, beverages and confectionery. Since then, domestic products have been back on the market; however, the materials used to produce Vietnamese goods are imported; hand, the quality and design of Vietnamese products are lower than some goods from other countries, especially Thailand products that are easily imported into Vietnam through Cambodia and the Gulf of Thailand.

The products of Thailand are better than Chinese products in terms of quality and design. Some Vietnamese goods such as plastics, textiles, agricultural products and foods are better than Chinese products; However, if companies still not improving the quality and design of products and reduce product costs, Vietnamese products do not compete with foreign products from Asia, Europe and the USA .; in particular, Vietnam has committed to removing barriers such as tariffs after joining a free trade agreement, the Trans-Pacific (TPP), ASEAN-EU, EU Vietnam, Vietnam South Korea, ASEAN-Canada Alliance, Vietnam - EFTA Vietnam Customs Union. This will help many leading retailers to bring goods and get market share in Vietnam.

Besides marketing strategies, Vietnamese enterprises have not actually taken to promote the advantages of domestic products. Vietnamese people also tend to prefer the use of foreign products due to bias with domestic products, leading to a skewed consumption behavior of the Vietnamese people. To reactivate the Vietnamese trade, Vietnam needs a lot of efforts to change the mindset of business of manufacture of manufacturers, distributors and retailers, and above all, the government should take appropriate measures in line with the trend of integration strategies.