DIA Middle East Regulatory Conference

Globally there are track and trace regulations being issued by many countries to protect patient safety, ensure product integrity and reduce counterfeit risks. United States, European Union, Brazil, China are some examples where barcoding serialization is being mandated. Implementation of these new standards could impose challenges both on regulatory bodies and the industry Many of the countries in the region are either implementing or considering implementation of barcoding and serialization in different ways for different reasons. By 2018, majority of the global drug supply will fall under some type of barcoding & serialization requirement. Since barcoding & serialization regulations will vary from country to country, pharmaceutical industry could face an unprecedented complexity, cost and risk on how they implement strategies in different parts of the world. This session would address some of the fundamental question asked and explores challenges faced in the proper implementation of the barcode and serialization. Ideally we would like to reduce such challenges and avoid when possible by addressing the below