Academy Training
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The ‘Making’ of a Good Responsible Person
Despite the MHRA’s guidance note 6 there is a lack of a clearly defined and standardised route into becoming a trained, experienced, and effective Responsible Person (RP), and consequently the MHRA are now placing a greater emphasis on the suitability of a licence holder’s RP, perhaps in an attempt to ensure that all roads eventually lead to the same destination or to gradually develop and define the necessary route, or maybe both…
Standards for Everyone…
For the last 3 years, when delivering GDP Training, and when it comes to the subject of Transportation – and the related GDP requirements – there has always been stock comments and specific observations…
Will the regulators be able to handle all this extra regulatory work ?
The EMA( European Medicines Agency) set up a task force to prepare for the possible eventualities of the UK referendum. They had several areas of concern the main one being the potential disruption to the supply chain of medicines and the impact in public health. The...