Serialization Regulatory Requirements for EMEA (Europe, Middle East, and Africa)
Serialization mandates are either in place, or on the horizon, in many EMEA countries. If you market or plan to market product in these regions, sound serialization programs are a must. In this course, you will obtain a detailed analysis of the latest requirements (and outlook) for serialization and traceability mandates in Europe. Course content will focus on a top-down analysis of the Falsified Medicines Directive (FMD) and other important market considerations including:
- Tools that will help you prepare for any serialization future in the EU, Middle East & Africa
- What Turkey’s early adoption of serialization and traceability systems has taught the rest of the world about technology development in this field
- Key countries proposing to comply with FMD, and what it will mean for doing business in these countries
- Actions the European Commission is taking to combat counterfeiting and reimbursement fraud, including the influence of EFPIA (European Federation of Pharmaceutical Industries and Associations)
- Understanding the European Stakeholder model, and how to comply
- The outcome and influence of important pilot projects in Sweden and Germany (SecurPharm), and how they can help your organizations
- Developments and business impact of counterfeit prevention legislation in Cameroon, Saudi Arabia, Libya, Algeria and Jordan
This course will be of benefit to anyone involved in serialization or supply chain pedigree in EU, African or Middle Eastern markets. Additionally, those who need to be able to communicate internally with supply chain personnel or vendors responsible for product distribution will find this course extremely beneficial.
Gordon Glass is an experienced subject matter expert from the pharmaceutical industry, recently moving to consulting services. He has specialized in GS1 standards, AIDC (Automatic Identification Data Capture), electronic product coding, pharmaceutical serialization/track & trace, and the implementation of pharmaceutical supply chain process/technology.
In recent years, he coordinated intelligence gathering of global market requirements for electronic product coding, product serialization, and product track & trace (including e-Pedigree for California). Mr. Glass led global design efforts for a global pharmaceutical company devising compliance solutions for serialization and traceability/authentication.
Mr. Glass has a Bachelor’s Degree in Chemistry from Susquehanna University (Selinsgrove, PA).