Pharma Regulations and Technical MasterClass

The training course will support you in collecting, sorting and proper understanding of the requirements of the EU Falsified Medicines Directive. This includes the relevant information related to the defined two EU-safety features, which are a unique identifier and tamper evident closures to be applied to the packaging of medicinal products within the EU starting 9th February 2019. Also this course will deal with the existing and emerging global serialization and track and trace requirements for medicines and their packaging in markets such as China, Korea, US and others. This course will also deal with Artwork Security and Audit Trails of Artworks Management.

By the end of the MasterClass, the participants will understand:

• The Requirements for EU-Falsified Medicines Directive 2019

• The Serialisatons Effects and consequences

• EU falsified Medicines Directive

• Artwork Management

• Digital Content Management