Core Insights - The training course titled "Global Regulatory Requirements for Drug Safety & Pharmacovigilance" is aimed at pharmaceutical and biologic companies in the US and EU, focusing on product safety regulatory requirements [1][2]. Group 1: Training Course Overview - The course is designed to help companies understand the latest compliance expectations in pharmacovigilance to maintain product marketability [2]. - It emphasizes the importance of having adequate systems and processes for safety reporting to avoid significant consequences, including product recalls [2]. Group 2: Learning Objectives - Participants will learn about the regulatory requirements for drug safety, including the US, EU, and UK frameworks, and specific details regarding EU GVP modules [6]. - The course will cover the contents of the Pharmacovigilance System Master File (PSMF) and the requirements for quality oversight of drug safety [6]. - Key topics include signal management regulations, UK QPPV responsibilities, and penalties for non-compliance [6][8]. Group 3: Target Audience - The training is relevant for nearly all individuals involved in drug development and marketing, including executives with legal responsibilities for drug safety [5][6]. Group 4: Instructor Profile - The course will be led by Steve Jolley, a subject matter expert with 37 years of experience in drug safety and pharmacovigilance, who has worked with over 300 clients globally [10][12].