The Organisation for Professionals in Regulatory Affairs (TOPRA)

TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs. They work with our members internationally to enable and promote excellence across the healthcare regulatory profession. The organisation known today as The Organisation for Professionals in Regulatory Affairs (TOPRA) began as The British Institute for Regulatory Affairs (BIRA). Nine subscribers who signed their constitution in November 1978 committed the organisation to fulfilling the following objects: To establish professional identity and standards for regulatory affairs personnel in the pharmaceutical and related fields To promote education and science in regulatory affairs To advance the professional competency of its members To promote co-operative relations with other allied organisations To collect and circulate relevant statistics and information of all kinds These were ambitious goals at a time when ‘product registration’ was poorly understood, geographically fragmented and undervalued; being regarded as a potential barrier to commercial success, rather than an enabler of innovation. In the following years, these goals have been accomplished, yet remain valid for TOPRA today, where education, co-operation, standard-setting and competence remain at the heart of their strategy. Since 1978, successive leadership teams have developed the tools to promote the professional identity of those working in healthcare regulation, culminating in TOPRA being licensed by the Science Council to award the Chartered Scientist accreditation (CSci) in 2018.