On 1 July, 2011 the European Commission published the Falsified
Medicines Directive (FMD) 2011/62/EU in the Official Journal of the European Union. The Directive
introduces measures to prevent the entry of falsified medicines into the legal supply chain.
This presentation will highlight the threat posed to the legal supply chain by falsified medicines and then move on to cover the new obligations for manufacturers and wholesale distributors of medicinal products, as well as those being introduced for brokers and manufacturers, importers and distributors of active substances.
Richard Andrews, Expert GMDP Inspector
The availability of medicinal products is an important aspect of public health, and contributes to patient safety. Availability of medicinal products is dependent on supply chain resilience. Recent disruptions to supply of essential medicines have lead EMA to publish a reflection paper on the topic. The reflection paper promotes the need for marketing authorization holders to undertake better and more proactive risk assessments of their supply chains.
Brendan Cuddy, Scientific Administrator, EMA UK
In Europe, as well as globally, traceability is becoming more and more important for regulatory bodies and other stakeholders in Healthcare. The presentation will describe the situation in Europe and worldwide, exploring the important role standards play in the implementation of traceability.
Ulrike Kreysa, Vice-president Healthcare, GS1
Counterfeiting, packaging frauds, pharmacovigilance and effective recall
have become the main drivers of the global target for implementing a Track & Trace System together with
safe data transfer among all stakeholders during the lifecycle of the product. Turkey became a global pioneer
for this implementation and PharmaVision has been an efficient and quick implementer of the system, proving
to be a local role model for this application.
With its scientific and innovative approach, PharmaVision was capable of applying a novel process to existing packaging equipment with impressive results. The presentation will therefore provide a good practice example for Track & Trace implementation in accordance with current GMP requirements, Good Automated Manufacturing Practices, Good IT Infrastructure Practices and Good Engineering Practices.
Fatma Taman, General Manager, Pharmavision.
A company’s approach to ensuring security throughout a global supply chain..
Tom Cochrane, Business Process Development Manager, Napp
Increasing pressures on R&D budgets and complex supply chains are amongst the factors influencing firms’ IMP supply chain strategies. With the appropriate process, people and application of technology the opportunities for pooling supplies across protocols or adopting just in time labelling can be successfully exploited. Although these practices are well established in other sectors, the clinical trial arena has experienced challenges in adoption. This balanced perspective will provide an insight into some of those challenges and explore considerations for success.
Helen Underwood, Client Services Director, Fisher
An area commonly reviewed by the Regulatory Inspectors is investigational medicinal products' worldwide shipment in order to support clinical trial activities. This presentation will discuss the importance of the chain of custody associated with the shipment of IMPs, and, using a number of inspection findings as examples, will also cover important areas for consideration such as temperature control and manufacturer, courier and site interfaces.
Jason Wakelin-Smith, GCP Inspector, MHRA
View the full conference agenda.