Over the last few years, the inspectorate has tried to raise the profile of the important role of the RP. Deficiencies are now frequently cited against the RP and sometimes the licensing authority has seen it necessary to take action by compulsorily varying the licence to remove an RP.
Another way the inspectorate has tried to raise the role profile has been by working with Cogent to develop the Responsible Person Gold Standard1. Training providers can now be approved; and the inspectorate would like to see a greater uptake of the Cogent approval process. We believe this will raise the profile of the role and contribute significantly to the integrity of the medicines supply chain in the UK.
Choosing an external training provider.
The licence holder is required to provide an RP with adequate knowledge and experience, learning ‘on the job’ is usual in this industry but experiential training can only provide for some elements of the full package. There is a place for good quality external training and this should be considered by all licence holders. Before arranging any external training, the Licence Holder and RP should be fully aware of the collaborative work on the Responsible Person Gold Standard between the GDP Inspectorate and Cogent Skills (see below). There is, effectively, a hierarchy of RP training provision in the UK.
The following shows the range of external training and the extent to which they are recognised by MHRA.
- Any training provider may offer RP training. Current offerings range from extremely generic courses that don’t even reflect EU GDP to high quality, targeted courses delivered in the work place. Many of these have not been recognised by the MHRA and so provide the least assurance to the purchaser. The buyer must verify the content is accurate and suited to their needs.
- A training provider may align their training with the Responsible Person Gold Standard but without recognition from MHRA. Once again, there is a range in quality, and the buyer must be wary. Many of these providers are, however, long-established and can provide references.
- RP training courses recognised by MHRA are available. A training provider may align their training with the Responsible Person Gold Standard and then apply to have their course recognised by Cogent Skills and the MHRA. The recognition is a result of a robust QA process of mapping the provider’s course to the RP Gold Standard, which then provides successful delegates on the courses with Cogent / MHRA certificates (more details are below). Providers may be part way through this process so if you want a fully recognised course then you will need to follow the notes at the end of this blog.
Collaborative work between the GDP Inspectorate and Cogent Skills - The Responsible Person Gold Standard
In 2013/14 an opportunity arose to develop a Responsible Person Gold Standard to join the other industry Gold Standards already published by Cogent.
Cogent Skills is the UK’s strategic body for skills in the science industries, working with sector employers to develop, design and deploy skills programmes and initiatives. With more than a decade’s experience in science industry skills, it is the expert delivery partner for the Science Industry Partnership (SIP) and works with the SIP to support liaison between industry and the Government departments responsible for skills development.
The GDP inspectorate worked with Cogent, industry representatives and industry training providers to achieve the publication of the Gold Standard: Responsible Person Medicinal Products in 2014. The Gold Standard is a competency framework, or role profile, and should be used by:
- The Licence Holder to assist in selection and induction of the RP
- The RP in identifying the extent to which he/she fulfils the role and in compiling a training programme
- The prospective RP in planning their learning and experience to prepare for a future role
Cogent Skills hold the Responsible Person Gold Standard. This is publicly available on their website1 and is repeated in Rules and Guidance for Pharmaceutical Distributors 20172.
The Responsible Person Training Standard; achieving Cogent Skills and MHRA recognition
Further collaborative working with Cogent Skills and the industry has developed the Gold Standard role profile for the RP into the Gold Standard Training Standard for a Responsible Person. The training standard is not publicly available but is used by Cogent Skills to assess training providers and the content of their RP courses. This is an excellent opportunity for training providers to have wider recognition for their RP training. There is a charge for this to cover the QA process. This can be applied to training by external providers; for internal training; or for consultants providing training as part of their offering.
Here is a quick overview of how the mapping to the training standard and recognition by Cogent Skills and MHRA takes place:
- Firstly, the training provider must register as a ‘Cogent Skills Provider’ and become a member of the Cogent Skills Provider Network. The membership process entails Cogent Skills Services checking trainer CVs, the provider’s internal quality assurance processes, details of the trainer delivery experience and employer endorsements. These checks are repeated on an annual basis.
- Secondly, the training provider submits their training materials and must demonstrate how these map to the learning objectives. The materials should include post-training assessments to confirm an individual’s understanding and knowledge of the subject matter.
- Thirdly, a successful submission will be logged as recognised by Cogent Skills and the provider will be permitted to award the successful attendee a certificate carrying the MHRA logo. Only those providers who have completed the entire process are permitted to issue a certificate carrying the MHRA logo.
MHRA now anticipate that uptake of recognised courses will increase, and we will be keeping an eye on progress when out on inspection.
To find out more about having a course recognised please contact Cogent Skills directly3.
To find recognised RP training: Skills Stores Providers who have completed the recognition process for the Training Standard & Training Provider Guidelines can be found by searching for ‘Responsible Person’ on the Cogent Learn Skills Store. Some listed may not have completed the recognition process. Look at the full details of each course; those with a disclaimer may not have completed the process e.g. “The ****** Responsible Person course has not been mapped to the Responsible Person Gold Standard course”
The Cogent recognition process gives you much greater assurance on the standard of external training. The inspectorate wants to see a greater uptake of this and we hope the approval process, and this set of three posts, will contribute to the development and recognition of the RP role across the industry.
The next of these three posts will look in greater detail at the licence holder’s responsibility to appoint a suitable RP.
References and Notes:
- Gold Standard: Responsible Person Medicinal Products http://www.thegold-standard.co.uk/job-details/?jobid=297
- Rules and Guidance for Pharmaceutical Distributors 2017, Pharmaceutical Press, London 2017 ISBN 978-0-85711-286-6 (The Green Guide)
- Find out more about getting training approved https://cogentlearn.com/course/view.php?id=271 or call 01325 740900
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