Stability Testing of Pharmaceuticals and Biopharmaceuticals (Online Training Course: July 21-22, 2025) - Increase the Likelihood of Studies Receiving Regulatory Approval and Save Resources on Stability Testing

Core Viewpoint - The "Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course" has been introduced to enhance knowledge and skills in stability testing, crucial for regulatory compliance and market readiness [1]. Group 1: Course Overview - The course is an intensive two-day seminar designed to provide practical exercises and knowledge application under experienced trainers [2]. - It now includes specific details on the stability of biopharmaceuticals, expanding its relevance to current industry needs [3]. Group 2: Target Audience and Benefits - The course is aimed at personnel involved in stability testing, including those responsible for designing and managing stability studies [4]. - Attendees will learn to carry out appropriate stability studies, manage samples, and design studies suitable for global marketing, potentially leading to significant financial savings [5][6]. Group 3: Key Topics Covered - The curriculum includes background on stability testing, guidelines, storage tests, conditions, and protocols [4]. - Participants will engage in exercises focused on designing stability protocols, data treatment, and understanding stability requirements for new and existing products [7][8]. Group 4: Regulatory Compliance and Quality Assurance - The course emphasizes compliance with stability requirements for drug substances and products, including the production of regulatory documents that incorporate stability data [6]. - It covers relevant guidelines such as ICH, EU, and USA standards, ensuring participants are well-versed in the necessary regulatory frameworks [8][10].