EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,...

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system valida...

Since July 2013, Regulation (EC) No 1223/2009 on Cosmetic Products of the EU has been fully implemented and represents a modern regulatory framework grounded on state of the art of cosmetic science and product technology. It is structured in regulatory modules, which include the safety assessment and the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), Responsible Person (RP), label information, cosmetovigilance, substanc...

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, imp...

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment....

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equival...