Training for Responsible Persons

 

With the new EU Guidelines on Good Distribution Practice and recently published MHRA Gold Standard, the MHRA are focusing more on more on the role of the Responsible Person.

Until recently, there has been no requirement for Responsible Persons to have formal qualifications.

The MHRA have now issued guidelines, in the form of a Gold Standard, on the experience, knowledge and skills expected of a Responsible Person.

This RP Training Course is for:

  • New RP’s
  • Existing RP’s
  • Deputy RP’s
  • Managers and senior managers who wish to understand more what is required of Responsible Persons.

This one day course is run “in-house” although external courses may be run.

RP Training Course Content
The MHRA
  • History
  • Departments
  • Inspection Action Group
  • Enforcement Group
  • European Medicines Agency
  • Home Office
  • Inspections
The Wholesale Dealers Licence
Qualifications for a Responsible Person
  • Experience
  • Education
  • Knowledge
  • Skills
Duties of the Responsible Person
What is needed to carry out the duties of a Responsible Person
In-depth review of EU Guidelines on Good Distribution Practice

Practical examples of many of the aspects of the role of the Responsible Person are given throughout the course

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