Course Mapping and Certification
Course Mapping and Certification
Medicinal Products - Responsible Persons
Cogent Skills alongside the Medicines & Healthcare products Regulatory Agency (MHRA) have developed a new Gold Standard role profile for Responsible Person in Medicinal Products which in turn has led to the agreement of a training standard which is recognised by the MHRA. 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. The training standard shows what good training entails to meet the Gold Standard competencies.
Cogent Skills can now offer official recognition that your training meets these standards, as well as provide certificates which will feature the MHRA logo to individuals who have undertaken the assured Gold Standard training.
To find out more information & pricing download the leaflet here
The MHRA also recognise the standards in the Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
The MHRA is the UK Government agency that regulates medicines and medical devices to ensure their quality, safety and efficiency can place the UK at the forefront of a global drive to improve public health.
"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.”
Mark Birse, Group Manager GMDP Inspections at MHRA
The Gold Standard
The Cogent Skills Gold Standard is a Competency Framework for individuals in the science based industries. The Cogent Gold Standards set an aspirational industry standard for expected levels of on-the-job performance. Training standards that are derived from the Gold Standards set out the learning objectives needed to achieve those levels.
It supports individual Continuing Professional Development (CPD), setting out the skills required for world class performance in key job roles. When companies invest in upskilling, one of the key factors to consider is the ability to demonstrate that delegates receive consistent quality training, and that learning outcomes are meaningful and measurable. This is particularly important in regulated industries such as the science industries.
One of the ways that companies can gain reassurance that delegates are being trained to a national level is to procure training that has been mapped to the learning objectives detailed in the training standards.
Cogent Skills is now able to map your Responsible Person course against the Medicinal Products training standard which will provide you with the ability to give your delegates certificates.
We can also host your course assessment on our online platform which will give your delegates a simple way to demonstrate their learning. If you are interested in this please ask for a quote.
To view the Role of Responsible Person in GDP for medicinal products course and our delivery partners click here