13 May 2014
Cogent SSC is pleased to announce a new Gold Standard role profile for Responsible Person in Medicinal Products. The release of the RP Gold Standard follows extensive discussions with pharmaceutical companies, the regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) and Cogent (the national skills body for the science industries).
The Gold Standard is a Competency Framework for individuals in the
science based industries. It sets out an industry standard for expected levels
of on-the-job performance. It supports continuing professional development
(CPD), setting out the skills required for world class performance in key job
roles. The Gold Standard job roles are developed by sector employers using the
four skills areas: technical competence, compliance, business improvement and
functional & behavioural. The defined job role skills are much broader than
technical and seek to equip an individual with a world class skill set.
Mark Birse, Group Manager GMDP Inspections at MHRA commented “Responsible
Persons play a vital part in ensuring the quality and the integrity of
medicinal products are maintained throughout the distribution chain. It’s
essential that they have the right knowledge, demonstrate competence and deploy
the right skills so that patients and healthcare professionals have the
confidence and trust to use medicines.
“We completely support the decision by industry to adopt the Gold
Standard framework to standardise the requirements for the Responsible Person
as it will generate a template for excellence in this role for the future.”
The Responsible Person Gold Standard sets out an industry agreed
framework that identifies the skills required by a Responsible Person in four
skills areas. This spread of skills ensures that the role includes not only the
traditional qualifications and technical requirements but also the behavioural
skills required to do the job to a high standard. These include business
improvement, leadership and communication.
John
Holton, Operations Director at Cogent said “It is a fantastic step for the
Pharmaceutical industry in developing a clear standard for the Responsible
Person role to meet their requirements. The Gold Standard framework provides a
solid foundation on which the industry can build a workforce, which is not only
technically skilled but also competent in the wider demands of the role that
are not taught as part of a qualification or course.”
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