The biggest bio exhibition-Bio Asia 2023!
TALENT CRO Inc. will meet you at booth M927!
Bio Asia-Taiwan 2023 will be held July 27-30, in Taipei, Taiwan. This event is the biggest bio exhibition in Asia and it brings thousands professional visitors to attending.
This year TALENT will be exhibiting Bio Asia-Taiwan 2023 with our partner CCRC M in Nangang Exhibition center Hall 1.
Good Distribution Practice Regulations– Western Pharmaceuticals
TFDA has announced a draft for drug categories, matters, methods, and timelines in May 2023 base on the implementation of the Western Pharmaceuticals Good Distribution Practice (GDP).
Announcement of medical devices shall be indicated Unique Device Identifier.
In February 2023, TFDA established the Regulations for Medical Devices are required to place UDI on labeling or minimize package based on Article 33, of the Medical Device Act, and abolished Announcement No. 1101602479. The regulations require that UDI be displayed on the primary packaging or the device itself for class II and III medical devices. If the packaging or device is too small, the UDI should be marked on the smallest sales package.
How do manufacturers prepare for MDR?
Recently, the European Union passed the resolution about the extension transition period of MDR until 2027 or 2028. The new deadlines depend on the type and risk class of medical devices. The implementation of extension is due to many reasons, such as pandemic, long-term review time, much higher requirements of clinical data and evaluation. All of the above reasons cause the medical device with MDD certificate can’t meet MDR requirements on time then going off the market.
Clinical Trial Phases
Clinical trials are used to determine the influence after human take drugs, medical devices or treatments. Clinical trials have multiple phases, that build on one another. Each phase helps answer different questions about the new drugs/medical devices/treatment and needs to be completed successfully before moving on to the next phase.
What is an Electronic Data Capture (EDC) System?
Many clinical data be collected and recorded in clinical trials, such as personal health record (PHR), informed consent form (ICF), clinical trial visit record or lab data etc. In the past the clinical data recorded on paper which is traditional CRFs. With traditional CRFs, it can’t assure data reliability (unintentionally modification) and security (loss paper) cause the processing of data collection and management will become slower.
