PHDS HEALTHCARE RESEARCH Co., Ltd.
Actively follow the new policies and regulations to ensure synchronization with the latest policies.
Release time:
2013-04-10
As a professional CRO company, PHDS actively keeps up with changes in policy regulations and participates in various professional training on new policies and regulations from the CFDA. This ensures a comprehensive understanding, grasp of the spirit, mastery of details, and synchronization with policies, to guarantee that all work operates on the right track.
As a professional CRO company, PHDS actively keeps up with changes in policy regulations and participates in various professional training on new policies and regulations from CFDA. This ensures a comprehensive understanding, grasp of the spirit, mastery of details, and synchronization with policies to guarantee that all work operates on the correct track. Recent training attended includes:
1. Participated in the "GMP Document System Preparation and Application Technology Training Course" (GMP, 2010 version): (Hangzhou training, March 7-11, 2013) Training content:
① Requirements of GMP for document systems and document control
② Requirements for facility and equipment system documents
③ Requirements for quality control system documents
④ Requirements for validation management system documents
⑤ Requirements for production management system documents
⑥ Methods for preparing record forms
⑦ Methods for preparing procedural documents
⑧ Methods for preparing quality standard documents
2. Participated in the "Drug Business Quality Management Specification Promotion Training Course" (GSP, 2012 version):
(Beijing training, April 8-10, 2013)
The new GSP will officially be implemented on June 1, 2013. It represents a significant adjustment in China's drug circulation regulatory policy and a substantial enhancement of the conditions and normative requirements that drug business activities should meet. The new regulations require drug business enterprises to fully implement a computer management information system, strengthen key links such as drug purchasing and sales channels, storage temperature and humidity control, and drug cold chain management, and introduce new management concepts and methods such as quality risk management, internal system audits, and equipment validation. The newly revised drug GSP establishes new regulations for various aspects of quality management elements such as personnel, institutions, facilities and equipment, and system documents in drug business enterprises, covering procurement, acceptance, storage, maintenance, sales, transportation, and after-sales management.
(Helen PHDS)
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In December 2023, PHDS HEALTHCARE RESEARCH Co., Ltd. was elected as the vice president unit of the China Food and Drug Enterprise Quality Safety Promotion Association, as well as the vice chairman of its subordinate digital professional committee (Certificate No.: Zhong Shi Yao An Cu Hui Zheng Zi 798). The election and award ceremony took place at the Three Gorges Hospital of Chongqing Medical University.
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On March 26-27, 2024, the China Wuxi Global Oral Forum and the China Food and Drug Promotion Association High-Quality Development Conference, guided by the Wuxi Municipal People's Government and the Wuxi Council for the Promotion of International Trade, and organized by the China Food and Drug Promotion Association and the Oral Health Committee of the China Food and Drug Promotion Association, will be grandly held at the Wuxi International Conference Center.
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