Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Regulatory Affairs Professionals Society

Executive Development Program at the Kellogg School of Management

Learn from faculty at one of the world’s most prestigious business schools in an environment dedicated to preparing ...
Regulatory Affairs Professionals Society

Global Regulatory Affairs Professionals Workforce Report

RAPS and Elemed are pleased to release the 2nd edition of this ground-breaking white paper, which provides a snapshot of the ...
Regulatory Affairs Professionals Society

EMA proposes new method to reduce animal drug testing

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new ...
Regulatory Affairs Professionals Society

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
Regulatory Affairs Professionals Society

RAPS Workshop: Cybersecurity Unauthorized

Understand the technical challenges and regulatory expectations faced by biopharmaceutical development scientists and regulatory professionals during the product development lifecycle.
Opinion
Regulatory Affairs Professionals SocietyOpinion

Former officials propose changes to FDA’s plausible mechanism pathway

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent draft guidance on the development of a plausible mechanism framework for ...
Regulatory Affairs Professionals Society

APAC Roundup: India’s CDSCO streamlines requests to export active substances to Europe

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good ...
Regulatory Affairs Professionals Society

Regulatory Affairs Career Guide

A quick regulatory affairs career guide, with advice and resources for beginners, leaders, and everyone in between ...
Regulatory Affairs Professionals Society

Foundation in Regulatory Affairs (FRA)

Show the world that you have the foundational knowledge regulatory affairs professionals need. The new Foundation in Regulatory Affairs (FRA) assessment-based certificate is designed to help you build ...
Regulatory Affairs Professionals Society

Call For Authors

As a leading publisher for regulatory professionals, RAPS is always interested in new manuscripts. Whether your idea involves prescription drugs, generics, over-the-counter products, biologics, ...
Regulatory Affairs Professionals Society

Leadership Programs

In regulatory affairs, what gets you promoted to a leadership role is not necessarily what will help you succeed in one. While early-career regulatory roles often focus on technical knowledge, ...