Orphan Drug Designation
An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare disease (affecting less than 200,000 patients in the United States and/or 500,000 patients in the European Union). What does it mean to be granted orphan drug designation? Orphan drug
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Pharmaceutical Quality System (PQS)
Overview Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in accordance with the Marketing Authorisation. To ensure this, the PQS is utilized. Adequate resources (locations, equipment, and employees), a sound quality policy with appropriate quality targets, and documentation of
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Overview Of GMP
1. Background of GMP In the United States in the early 20th century when the industry was still aboriginal (ice was used for refrigeration, and milk was also unsterilized). Preservative chemicals and food additives are arbitrarily used without supervision. The drug contains heroin, cocaine and morphine with no warning on the label. In 1937 the
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Measures For Drug Price Management In Vietnam
The following below contents do not contain the full and detailed information of the Decree 54/2017/ND-CP and the Decree 155/2018/ND-CP , but the information is extracted and summarized briefly as a part of the Decrees on measures for drug price management in Vietnam. 1. Declaration and re-declaration of drug prices Every pharmacy business establishment shall
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The Lifecycle Approach to Process Validation: Overview
The current view of the world’s regulatory authorities is that Process Validation (PV) demonstrates the adequacy and robustness of the manufacturing control strategy and gives continuing assurance that the process is under control. It is defined in the November 2016 EMA Guideline on process validation as: “Process validation should not be viewed as a one-off
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T-Shape & Business Acumen – Core Competences And Values Of HR Professionals
Human Resources covers multiple functions besides general HR (Recruitment, C&B, T&D), and the value that HR professionals add to the business reaches far and wide. You can provide general advice to your business, support the implementation of technology or other digital initiatives, build and maintain a healthy organizational culture, or strategically integrate the HR value
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How Is A Drug Manufactured? New Drug Research And Development Process
Research and development of many new drugs open up treatment opportunities and change the lives of millions of patients. However, developing and manufacturing new drugs is a very difficult process, requiring a lot of research time, equipment, resources, and huge costs. 1. More than a decade path for a new drug to be born Every
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Summary of intraocular lens market information in Vietnam 2021-2022
The following article provides information, overview data and latest trends about the intraocular lens market imported to Vietnam. The data provided in the article is based on Big data of Orioledhub. A. MARKET OVERVIEW An Intraocular Lens implant (or artificial lens implant) is a synthetic lens placed inside the eye that replaces the focusing power
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Chirty In Chau Thanh, Ben Tre
Yesterday, September 4, 2022, TV TPI cooperated with the Red Cross Society of Tan Binh District to give 50 gifts to disadvantaged students from poor households in Chau Thanh town, Chau Thanh district, Ben Tre province. The students from elementary to high school, with innocent eyes, but also full of joy and excitement because they
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Marketing Authorisation Holder
EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime in relation to its safety, quality and efficacy, lies with the Marketing Authorisation Holder (MAH). The MAH must have appropriate controls in place and operate a Quality Management System to support the activities related to these controls. So,
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