Scope
With the fast approaching deadline of the 9th of February 2019 to fully comply with the Directive’s requirements, this course aims to provide you with the necessary knowledge and understanding of the EU Directive 2011/62/EU and associated delegated act related to falsified medicines.
It will provide you with an understanding of the background, principles and requirements related to the directive such as the “Unique identifier” and “safety features”, the impact on the pharmaceutical and supply chain industries and the technical challenges associated with the implementation of the required systems and processes, as well as how to monitor and control compliance from a quality point of view.
Suitability
The course is aimed at key personnel involved in the traceability and verification of medicinal products across the supply chain, including those involved in the manufacturing, packaging, storage, distribution and dispensing that must be fully aware of the principles of the EU’s Falsified Medicines Directive and delegated act as well as the related practicalities to ensure full implementation and compliance.
Personnel involved in management, QA, QC, RA, IT infrastructure, Storage/Distribution and Dispensing would particularly gain the necessary knowledge and understanding to implement and apply the necessary IT infrastructure, controls and processes associated to the FMD.
By the end of the course attendees will:
- Understand the reasoning behind the EU’s FMD.
- Understand the requirements of the FMD and delegated act.
- Be familiar with the requirements and how these are expected to be applied across the supply chain by the key stake holders, from manufacturing to the dispensing of products to the end user.
- Be aware of how compliance will be governed within the EU.
- Be able to relate the requirements to their own company’s activities and responsibilities
