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Other Courses
GDP Obligations of the Licence Holder
In order to purchase, store, import, export or supply medicinal products a company must be in possession of a Wholesaler Dealers Authorisation (WDA) issued by the HMRA. A WDA cannot be issued without a Licence Holder having been nominated by the company.
In this training course we will cover the obligations of a Licence Holder with regards to EU Good Distribution Practice (GDP) Guidelines and Human Medicines Regulations 2012.
By the end of the course, you will have a thorough understanding of the role and responsibilities of the Licence Holder and how you as a Licence Holder can ensure full compliance with the guidelines and regulations in your organisation.
Introduction to Pharmacovigilance in Good Distribution Practice
This course provides a comprehensive overview of pharmacovigilance (PV) within the context of Good Distribution Practice (GDP) in the UK and EU. It is designed for persons involved in supply chain, quality, and distribution roles, including Responsible Persons.
Key learning areas include the management of spontaneous safety reports, the implementation of additional risk minimisation measures, the execution of patient support programmes, and the importance of regular data reconciliations and audits. Ultimately, you will understand how to maintain compliance and fulfil pharmacovigilance obligations within Good Distribution Practice.
GDP Awareness Training
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) came into force on November 5th, 2013, with the HMR2012 harmonising with the EU guidelines post-Brexit. Any person acting as a wholesale distributor must hold a wholesale distribution authorisation (WDA) and must comply with the guidelines for, and principle of GDP. No one is permitted to handle medicinal products without suitable GDP training, which must be submissible as a current certificate. This course includes additional information on the disapplication of the FMD. Guidelines on the Windsor Framework are also accessible.