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The Medicines & Healthcare products Regulatory Agency UK (MHRA)

MHRA

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. They are recognised globally as an authority in its field, and the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

Cogent Skills alongside the 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 read more on the RP standards click here 

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The MHRA agency is responsible for:

  • ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy
  • ensuring that the supply chain for medicines, medical devices and blood components is safe and secure
  • promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
  • helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
  • supporting innovation and research and development that’s beneficial to public health
  • influencing UK, EU and international regulatory frameworks so that they’re risk-proportionate and effective at protecting public health

If you would like to know more information in relation to the MHRA or the RP Mapping, contact us using the enquiry form below

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Cost

No Cost! The Medicines & Healthcare products Regulatory Agency UK 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

Solution Available

Responsible Person in Good Distribution Practice – Procedure Training Mapped to Industry Requirements

Responsible Person in Good Distribution Standards – Course Mapping and Certification Service for Training Providers

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