Professional Certificate in Regulatory Affairs
The Malta Medicines Authority was keen to improve the overall understanding of its staff in the field of regulatory affairs. While they already had an extremely high level of expertise in their own field of operations, the broader context of the regulatory sphere had been identified as being an area in which the Authority could very usefully improve the skills, knowledge and awareness of its staff at various levels of the organisation.
The brief was to cover the subject in broad terms, with a greater emphasis than usual on the subject area of protecting consumers, the public and ethics, with case studies from related sectors from which the lessons could be easily transferred and applied in the regulation of medicines.
ICPS has trained hundreds of senior staff from around the world in the field of regulatory affairs and our expertise in this field is substantial.
Our approach was initially to arrange a face-to-face meeting with one of the organisation's senior staff to discuss the precise content areas on which they wished to focus, and those which were not considered to be important.
After this meeting, ICPS's Head of Content held a briefing meeting with one of our regulatory expert trainers to refine to content for the initial five-day training programme draft to send over to the client for approval. The client discussed the proposed content of the training in a meeting and a few minor changes were requested, which ICPS duly incorporated into the programme. The programme was then approved formally and the trainers were selected by ICPS and approved by the client.
Our approach to designing and delivering the training was to deliver both skills training and knowledge and information over the course of the five days in a mixture of formats, blending various methods of learning and optimum strategies for retention and application in context. A mixture of presentations, workshops, opportunities for delegate input, facilitated discussions, feedback sessions and action planning strategy sessions were suggested, approved and employed.
An interesting aspect of this training was the way in which it was funded. A common model for the funding of in-house training is that the client organisation covers the full cost of the programme delivery. In this case, the Medicines Authority was eligible for funding through a government programme to cover the fees. The overall fee was divided between the number of participants and each participant applied on an individual basis for the government scholarship to cover that amount.
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