The regulatory profession is a relatively new profession, having been established just a few decades ago, and people still tend to enter the field from …
The SPC regulation was introduced 25 years ago and has resulted in a complex landscape of national case law and numerous decisions from the Court …
In 2008, the European Commission initiated a public consultation on existing requirements covering medical devices, which produced more than 200 comments and proposals for change …
With the participation of officials from the Ministry of Health in international conferences on pharmaceutical safety and the International Conference of Drug Regulatory Authorities (ICDRA), …
Ireland’s medtech sector is internationally recognised as a leading global cluster characterised by a deeply evolved ecosystem, encompassing leading multinationals, specialised research and clinical capabilities …
With nuclear medicine therapeutics expected to represent 60% of the projected $26 billion global molecular nuclear medicine market by 2030, new alternative treatments are now …
Inhalation of air is a vital process for all human life. Inhalation for drug delivery has been established as an effective delivery method of active …
Over the last decades, MALDI-TOF mass spectrometry (Matrix-Assisted Laser Desorption/Ionisation Time of Flight) has proven its usefulness and robustness in many applications, helping life scientists …
There are many challenges in bringing a good new product to market, from correctly identifying the right commercial opportunity and establishing appropriate input requirements, to …
Research sponsors and investigative sites are continuing to explore the use of electronic informed consent (eConsent) in today’s clinical trials. eConsent utilises electronic systems and …
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