On the 26th of October, the city of Porto will receive training for healthcare professionals who wish to broaden their knowledge of Good Distribution Practices, an event promoted by Wise Healthcare Solutions, a healthcare consulting firm.
The 1st edition of this training is accredited by the Order of Pharmacists and its trainers are Hélder Mota Filipe, associate professor at the Faculty of Pharmacy, University of Lisbon, Manuel Talhinhas from the Portuguese Association of Young Pharmacists and Mónica Povo, technical director at Rubeaspharma.
The course is intended for 25 participants and the registration fee is €500 + VAT.
The objectives are to deepen knowledge on the implementation of a Quality Management System and the elaboration of the Quality Manual, apply the Risk Management Principles to the activities carried out within the scope of the Wholesale Distribution of Medicines, improve knowledge regarding various issues related to the GDP and on the measures to be implemented to prevent the entry of counterfeit medicines into the European Medicines distribution circuit. Registration can be done on the website of WiseHS.
- The Pharmacist in the Supply Chain: The Pharmacist’s Role in Quality and Availability Assurance – FIP
- National and European Legislation on Good Distribution Practices for Medicines, Medical Devices and Active Substances
- Licensing of Entities in the Wholesale Distribution Circuit
- European EudraGMDP System: issuance of certificates and validity of certificates
- Obligations of the holder of a Wholesale Distribution authorization
- Good Distribution Practices
- Design and Implementation of a Quality Management System
- Quality manual
- Standard Operating Procedures (SOPs)
- Risk Management for Quality
– Subcontracted activities
– Monitoring of environmental conditions
– Computer Systems
– Customer Qualification and Validation
– Supplier Qualification
– Complaints regarding Medicines and/or Devices
– Doctors suspected of forgery
– Returns of Medicines and/or Medical Devices
– Transport of Medicines and/or Medical Devices
- Measures to be implemented to prevent counterfeit medicines from entering the medicine distribution circuit
– Medication Safety Devices
– Medicines that must have a Safety Device
– Regulation of the Delegated Act on Security Devices
– National and European Legislation on Safety Devices
– National Unique Identifier Support
– Verification of the authenticity of the Unique Identifier
– Obligations of the Wholesale Drug Distributor
– National Drug Verification System
- Inspection Procedures for Wholesale Drug Distributors
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