Essentials of EU and US Regulatory Affairs for Human Medicinal Products

Despite many similarities, researching, producing, marketing, and selling drugs differs between the US and EU. Due to past failures, companies assume primary responsibility for making safe medicinal products available, while also protecting consumers.

This module serves as an invaluable introductory training course for all staff in the pharmaceutical and biotechnology industries who are inexperienced in regulatory affairs and compliance. More experienced personnel will find it a useful reference tool. Healthcare professionals involved in the development of medicinal products will also benefit from this course.

Regulatory affairs consist of a series of processes that allow a company to obtain and maintain approval from regulatory authorities to market medicinal products. While these processes differ between the US and EU, both are vital for safeguarding public health and ensuring the availability of safe, high-quality medicines. The course will cover the following topics:

Regulatory Affairs Primer Define regulatory affairs and outlines the function and evolution of regulations in the pharmaceutical industry. It also provides sources for key legislation and guidelines, introducing national and international regulatory authorities along with the legal frameworks in the USA and EU.

The Life Cycle of a Drug: Examine the main differences between types of medicinal products, outlines the discovery phase and nonclinical studies, and offer a basic introduction to Good Laboratory Practice. It also identifies the four phases of clinical development and discusses special challenges associated with pediatric trials.

Registering a Drug: Address the regulatory requirements during the nonclinical studies phase and highlight key points of Good Clinical Practice. It introduces the regulatory processes involved in gaining marketing authorization in the EU and the USA. Additionally, it covers orphan drugs, line extensions, generics, naming conventions, and compassionate use.

After Marketing Approval: Explore post-marketing approval activities, including variations and supplements, line extensions, pharmacovigilance, Good Manufacturing Practice (GMP), basic patent law in the EU and USA, as well as marketing issues, advertising, and generics.

Gain a foundational understanding of regulatory affairs, enabling you and your company to protect consumers and maintain compliance with regulatory authorities.