Proposing guidelines for responsible person eligibility in Malta

Abstract

OBJECTIVES: To assess the current training and further education available to prospective Responsible Persons (RPs), to gather feedback from current RPs and industry stakeholders’ experiences and to recommend guidelines on what training and experience prospective RPs should undergo to become eligible for the role. METHOD: A focus group was organised with key stakeholders from the industry including representatives from the Medicines Authority, University of Malta and the Central Procurement and Supplies Unit (CPSU). Feedback on individual experiences was gathered. KEY FINDINGS: The most common recommendation from the focus group was the emphasis on the importance of having practical experience relative to the size and complexity of the operation. CONCLUSION: Guidelines to be proposed for a framework on accepting RPs should consider experience supported by knowledge on obligations and duties to be fulfilled by the RP.