Regional Regulations - EU

Fundamentals of EU Regulatory Affairs, Sixth Edition
Available
This book is an indispensable resource for professionals at all levels providing a comprehensive examination of applicable directives, regulations and national laws across the lifecycle for all product lines in the EU.

On-demand Webcast: EU Fundamentals: Clinical Investigations and Clinical Trials
Available

An on-demand recording of the RAPS Webcast on EU Fundamentals: Clinical Trials and Communication with Health Authorities, originally recorded on 7 September 2011.

Pharmaceuticals: EU Regulations
Available

This course provides an overview of the regulations and legislative framework, as well as the EMA entities pertaining to pharmaceuticals and review. The different application and registration procedures will be described, along with regulatory requirements for a product’s lifecycle, including marketing and postmarketing requirements, the switch to OTC, and enforcement regulations and mechanisms.

EU Regulations Bundle: Pharmaceuticals Focus
Purchase Fundamentals of EU Regulatory Affairs, Sixth Edition, European Product Liability Law, EU Regulatory Acronyms & Definitions and Pharmaceuticals: EU Regulations together and save on these indispensable reference tools, our most popular products to help you learn the pharmaceutical side of the EU regulatory healthcare industry.

Good Clinical Practice: A Question & Answer Reference Guide May 2012
Available
Get authoritative answers to hundreds of common and emerging questions in more than 20 Good Clinical Practice (GCP)-related areas..

EU Regulations Bundle: Device Focus
Purchase Fundamentals of EU Regulatory Affairs, Sixth Edition, European Product Liability Law, EU Regulatory Acronyms & Definitions and Medical Devices: EU Regulations together and save on these indispensable reference tools, our most popular products to help you learn the device side of the EU regulatory healthcare industry.

Medical Device: EU Regulations
Available
This course follows the regulatory requirements through the lifecycle of the product, providing a strong foundation of the key elements of the EU directive requirements, including the AIMDD,  MDD and IVDD. You will examine how devices are classified and how this classification affects the labeling, registration, marketing and postmarketing requirements.

EU Regulations Bundle: Device and Pharmaceuticals
Purchase Fundamentals of EU Regulatory Affairs, Sixth Edition, European Product Liability Law, EU Regulatory Acronyms & Definitions, Medical Devices: EU Regulations and Pharmaceuticals: EU Regulations together and save on these indispensable reference tools, our most popular and comprehensive set of products to help you learn the EU regulatory healthcare industry.

EU Regulations Bundle: General
Available
Purchase Fundamentals of EU Regulatory Affairs, Sixth Edition, European Product Liability Law and EU Regulatory Acronyms & Definitions together and save on these indispensable reference tools, our most popular products to help you learn the EU regulatory healthcare industry.

European Product Liability Law
Available
This book looks at product liability law in states both within and outside the EU, including Austria, England, France, Germany, Italy, Norway, Russia and Spain.