Regional Regulations

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.

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: General
Available
Purchase Fundamentals of EU Regulatory Affairs, Fourth 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.

Pharmaceuticals: US Regulations
Available

This course provides an overview of the history of pharmaceuticals in the US, the requirements to obtain prescription (Rx) and over-the-counter (OTC) drug approvals, and other requirements that are in place to ensure compliance with US Food and Drug Administration (FDA) regulations, such as pharmacovigilance reporting.

Fundamentals of Japanese Regulatory Affairs, First Edition
Available
This English edition is an indispensible resource for regulatory professionals working on products for the Japanese market.

EU Regulations Bundle: Device and Pharmaceuticals
Purchase Fundamentals of EU Regulatory Affairs, Fourth 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.

Fundamentals of EU Regulatory Affairs, Fifth 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.

US Regulations Bundle: Device Focus
Purchase Fundamentals of US Regulatory Affairs, Seventh Edition, FDA: A History, US Regulatory Acronyms & Definitions, FDA Regulatory Affairs and Medical Devices: US Regulations together and save on these indespensable reference tools, our most popular products to help you learn the medical device side of the US regulatory landscape.

Complete WHO Guidance Documentation Bundle
Available
Purchase all 4 handy pocket-sized guides containing WHO guidance documents together in this discounted bundle.

FDA: A History
Available
This DVD provides a comprehensive look at the history of the U.S. Food and Drug Administration.