Overview of drug registration in Vietnam in the period 2009-2019
Since 2008, Vietnam has been classified as a pharmerging country, according to IMS Health (IQVIA). Pharmaceutical spending per capita in Viet Nam is relatively low but has increased dramatically in recent years. In 2005: 9,85 USD (equivalent to about 227.000 VND), in 2014: 34,48 USD (equivalent to about 793.000 VND), forecasted to reach to 163
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The approval process of medicines in Europe
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised pro- cedure) alongside national procedures based on different EU Member States working together and recognizing each other’s evaluations (the so-called decentralised and mutual recognition procedures). It is a system that has evolved over the past half-century
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Happy Birthday to OrioledHub
At noon on May 27, 2022, Orioledhub’s birthday party took place in a joyful and warm atmosphere. With the theme of Go Green and the blue -white dresscode conveys the message of commitment to living green, together towards protecting the environment. The entire staff sat down together, sharing memories, laughter, hugs and handshakes in warmth.Besides,
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FRIENDSHIP BETWEEN TV TPI AND IMEXPHARM
On the morning of May 14, 2022 in Cao Lanh City, Dong Thap province, TV TPI was pleased to participate in the tennis exchange program with Imexpharm. As usual, every year TV TPI and Imexpharm meet, exchange and develop the sports spirit between the two companies. The program took place in a radiant and joyful
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Mission – Vision – Core Values at TV TPI
TV TPI: TALENT – STRENGTH – RESPONSIBILITY Mission Answering the ‘Why’ question of the organization, also known as the organization’s core purpose and reasons for survival. TV TPI was born to serve medicine users in Vietnam and Southeast Asian countries by providing valuable and quality products registered in Europe at reasonable prices. Vision Answering the
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QRM Application in GMP
Several important uses of Quality Risk Managementin GMP practice Quality Risk Management is increasingly becoming an integral part of an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality and business. It also facilitates continual improvement and is a good tool for knowledge management.
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COMPARATOR MANAGEMENT (P.2)
2. COMPARATOR DRUGS SOURCING PROCESS 2.3. Identification of the supply strategy to be used 2.3.1. Selection and communication of a comparator for a clinical trial The comparator sourcing process should begin approximately 9-12 months before the comparator is received. This should allow for contingency and to identify the best strategic option for the complete duration
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COMPARATOR MANAGEMENT (P.1)
1. INTRODUCTION 1.1. Overview A comparator drugs, also known as a reference drug, is one that is included in a clinical study for the purpose of making comparisons of its performance in a defined population. Comparisons may be made in terms of a combination of factors such as: Efficacy, safety, ease of use, patient compliance.
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