What is the primary focus of the RAC-GS exam?

The primary focus of the RAC-GS exam is on global regulatory practices in medical devices, pharmaceuticals, and biologics. This exam is designed to assess the knowledge and skills of professionals working in regulatory affairs on an international level. It covers the regulatory frameworks that govern the development, approval, and marketing of medical products worldwide, which is crucial for ensuring that these products meet the requisite safety and efficacy standards in various markets.

While local regulatory practices and national regulations are important, the RAC-GS specifically emphasizes a broader scope that encompasses various countries and regions, reflecting the increasing globalization of the healthcare and regulatory landscape. Additionally, although ethics in healthcare is a critical component of the regulatory environment, it is not the primary focus of the exam. The exam engages with the complexities of international regulations, making it essential for professionals involved in global regulatory affairs to understand the diverse requirements and processes across different jurisdictions.