An audit trail is a chronological record of system activities that provides documented evidence of specific events. In the pharmaceutical context, this can include changes to electronic records, alterations in critical parameters, or any other actions that could impact product quality.
- February 9, 2024 Pharmaceuticals, Compliance, Audit and Validation
- February 9, 2024 Medical Devices
Combination products, which are innovative therapeutic and diagnostic products that combine drugs, devices, and/or biological products, are becoming increasingly prevalent in the healthcare industry. In China, the registration of these products is governed by specific Regulatory frameworks that help ensure their safety, efficacy, and quality.
- February 7, 2024 Pharmaceuticals, Regulatory Artwork Services
In the rapidly evolving pharmaceutical landscape, where innovation meets stringent regulations, accurate and engaging communication is crucial. Enter eLabeling, a digital revolution transforming the way drug information is delivered. Central to this shift is the role of artwork—a crucial component that goes beyond mere aesthetics and delves into compliance, user engagement, and brand representation.
- February 7, 2024 Pharmaceuticals, Regulatory Artwork Services
The pharmaceutical industry is a sea of innovation, constantly churning out new drugs and treatments to improve human health. But just like any voyage, this journey is fraught with Regulatory storms that can threaten smooth sailing. One crucial aspect often overlooked in this tempestuous voyage is the power of Regulatory artwork.
- February 7, 2024 Chemicals, Regulatory Affairs
Navigating the Regulatory landscape of chemicals in Japan can be a complex and challenging, especially for businesses seeking to import or manufacture chemicals within the country.
- February 7, 2024 Chemicals, Regulatory Affairs
Chemical registration is a vital process that ensures the safe handling, usage, and distribution of chemicals within a country. In Thailand, the Food and Drug Administration (FDA) plays a crucial role in regulating and overseeing chemical registration.
- February 7, 2024 Pharmacovigilance, Regulatory Medical WritingPharmacovigilance is a critical field in healthcare that focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. A cornerstone of pharmacovigilance is causality assessment, which is the systematic evaluation of the evidence to determine whether a drug caused a particular adverse event.
- February 7, 2024 Pharmacovigilance, Regulatory Medical Writing
Traditionally, literature surveillance has been an effort-intensive process, requiring pharmacovigilance specialists to manually search, review, and analyze vast amounts of published/ unpublished data for potential adverse events (AEs) and safety-related information. However, Artificial Intelligence (AI), with its machine learning (ML) and natural language processing (NLP) capabilities, is changing the game.
- January 31, 2024 Publishing & Submissions, Regulatory Intelligence, Regulatory Software & Services
As we blast off into 2024, the life sciences industry is about to undergo a radical metamorphosis - not just a facelift, but a full-on cyborg upgrade. Regulatory affairs are set to morph into a sleek, interconnected beast, fueled by cutting-edge technology and global collaboration. Buckle up, because these five trends are about to reshape the entire game:
Unlocking the Synergy: Digital Health Technologies and Regulatory Mastery in Clinical Investigations
January 24, 2024 Pharmaceuticals, Regulatory Medical WritingThe integration of Digital Health Technologies (DHTs) heralds a transformative era in the realm of clinical investigations. From computing platforms to wearables, these technologies redefine the landscape, offering an innovative lens for evaluating medical products.