Brochure and Registration

Click on one of the following links to register for the conference:
Non-ECA Members, EUR 1.890 (per delegate plus VAT)
ECA Members, EUR 1.690 (per delegate plus VAT)
EU GMP Inspectorates, EUR 945 Euro (per delegate plus VAT)
APIC Members, EUR 1.790 (per delegate plus VAT)

Objectives
The aim of this conference is to present both the regulatory authorities’ activities and the pharmaceutical industry’s activities to develop and establish appropriate counterfeit protection systems. The conference will focus on effective and affordable strategies, improve collaboration among regulators and pharmaceutical industry, and discuss actions in the global fight against counterfeit.

Target Audience
This conference is intended for people working in

  • Packaging Development
  • R&D
  • Manufacturing / Packaging
  • Quality Assurance / Quality Control (QPs)
  • Purchasing and Materials Management
  • Regulatory Affairs
  • Counterfeit Protection Management of pharmaceutical, biopharmaceutical and API manufacturing companies.

    The conference is also intended for members of national or international authorities and for personnel working in Security Technology, and Packaging Components or Labelling companies.

Background
According to the European Commission the risk that falsified medicines reach patients in the EU is growing every year. And also the EMA is aware of a remarkable increase in falsified medicines. Until recently, the most frequently falsified medicines in wealthy countries were expensive “lifestyle” medicines. Today, more and more medicines used to treat serious illness are now being falsified.

The EMA and the European Commission differentiate between falsified and counterfeit medicines. While falsified medicines are fake medicines that are designed to mimic real medicines including its ingredients, documentation and supply chain, counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law.

In the fight against counterfeit medicines the European Union published the Directive 2011/62/EU about the prevention of the entry into the legal supply chain of falsified medicinal products in July 2011. The aim of this  Directive is to protect patients in the EU against falsified medicines. This includes:

  • obligatory safety features on the outer packaging of the medicines (such as an individual code per pack)
  • an EU-wide logo to identify legal online pharmacies
  • stricter rules on the controls and inspection procedures of APIs and excipients (e.g. written confirmation since July 2013 for APIs)
  • more stringent record-keeping requirements for wholesale distributors (see Good Distribution Practice Guideline, March 2013)
  • obligation of the manufacturing authorization holder to immediately inform on any suspected falsified medicinal product

The related Delegated Act to this Directive with more specific technical details how to proceed related to the safety features is expected to be published in 2014.

In this context, the EFPIA has established a European Stakeholder Model (ESM). The EMS is based on the concept that any medicinal product must be checked with its delivery (point of dispensing verification). The technical implementation is accomplished via the European Medicines Verification System (EMVS), which will enable the complete tracing of a medicinal product from thepharmaceutical manufacturer to the distributing pharmacy by means of using the 2 D Data Matrix Code.

In addition, an anti-counterfeiting traceability service proposal was launched in the EU by the European Directorate for the Quality of Medicines, EDQM, known as “eTact”.
Even though it is not sure which system will prevail, enough details are known now to get familiar with what is expected from pharmaceutical manufacturers to meet the requirements of the European Directive. And it is thus the aim of this conference to highlight the requirements a pharmaceutical company has to fulfil today in order to be ready for the future European Verification System.

Besides the European GDP Guideline requirements, more and more pharmaceutical companies are looking for new security standards for the transport of pharmaceutical goods. TAPA’s concept (Transported Asset Protection Association) is one example, which will be addressed at the conference, too.

And also in the US the “Drug Quality and Security Act” was approved by the House of Representatives and by the Senate and President Obama signed the Act into law on November 2013. This act is supposed to protect consumers and improve security in the pharmaceutical supply chain and to prevent counterfeit medicines from reaching patients.

This conference intends to inform participants about the latest regulatory requirements in the EU and the US and about the measures the pharmaceutical industry has to take now to combat counterfeit medicines.