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Rosalind Coulson (1955)

Ros Coulson (PhC Syd, MSc London, FRPharmS) is a pharmaceutical expert who became a world leader in drug development, information sciences and pharmacovigilance – the science relating to the detection, assessment, monitoring, and prevention of the adverse effects of pharmaceutical products. In recognition of her services to the profession of pharmacy in the UK, Ros was made a Fellow of the Royal Pharmaceutical Society in 1992.

Rosalind Coulson enrolled into 5th Grade at Â鶹ÊÓƵ School in 1949 and completed her Leaving Certificate in 1955. During her time at Â鶹ÊÓƵ School she was a member of the ‘A’ Hockey and Tildesley Tennis teams and was on the Sports Committee. After leaving Â鶹ÊÓƵ School, Ros studied Pharmacology at the University of Sydney and became a registered pharmacist in 1959. Ros moved to the United Kingdom and competed a Master of Science in Biopharmaceutics in 1982 at King’s College, University of London.

During her 25-year tenure at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, Ros held a number of roles. Initially she was the principal pharmaceutical officer and group manager. In this role she managed the chemistry and pharmacy assessments of new medicinal product applications, clinical trial certificates and exemptions, as well as variations and renewals of marketing authorisations.

After this, Ros moved into the Post-Licensing Division where she had oversight on the monitoring of the safety of all medicinal products in the UK. During this time she also developed and implemented ADROIT (Adverse Drug Reaction Online Tracking) – the system used to monitor and research safety data associated with the UK Yellow Card Scheme¹. Ros’ innovative ADROIT system won a Smithsonian Institute (USA) award for its contribution to medical science.

Ros also took on a special project to revitalised the UK General Practitioner’s Research Database. This remains one of the most important sources for pharmaco-epidemiological research in the UK today.

During her time at MHRA, Ros also facilitated collaboration with other European pharmaceutical regulatory agencies, the World Health Organisation (WHO), and the pharmaceutical industry, on the improvement of drug safety and risk management methodology.

After becoming a member of the International Conference on Harmonisation (ICH), Ros was successful in standardising the international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry worldwide, by taking the medical dictionary she developed for her UK ADROIT system and developed MedDRA. MedDRA terminology is now used through the entire pharmaceutical regulatory process, from pre- marketing to post-marketing, for data entry, retrieval, evaluation, and presentation.

Further, through her involvement in the European Union (EU) and the ICH she was instrumental in the development of the international standard for the electronic transmission of individual case safety reports related to medicinal products.

Upon retirement from the MHRA, Ros Coulson served as an independent consultant on the safety of medicines to European regulators, the pharmaceutical industry, and medical service providers.

Footnotes

1. The Yellow Card scheme run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. The purpose of the scheme is to provide an early warning that the safety of a medicine or a medical device may require further investigation.

References

Biography and Curriculum Vitae kindly supplied by Rosalind Coulson.