Connecting for Transparency and Healthcare Professional Interaction Conference by Informa
On August 12, a fireside chat hosted by Informa Connect will delve into the current regulatory landscape and emerging trends in the life sciences industry. The event, scheduled from 11:15am to 12:00pm, will bring together Pharma and MedTech visionaries for an insightful discussion.
Lauren Kootman, Principal Assistant Deputy Chief of the Corporate Enforcement & Compliance Unit, Fraud Section of the DOJ, will be participating in the chat. Joining her will be Amanda Masselam Strachan. The topic of the chat is "Enforcement Update - Examining Today's Regulatory Landscape and Emerging Trends".
The discussion will focus on HCP engagement, compliance monitoring, and data reporting and governance. With the life sciences industry facing significant changes marked by fast-paced policy shifts and growing regulatory scrutiny, the chat aims to provide valuable insights into upcoming areas of regulatory focus for 2025 and beyond.
The regulatory landscape is rapidly evolving, with critical areas of focus for 2025 including increased regulatory complexity, AI in drug development, and expectations for compliance programs that emphasize transparency and proactive risk management. Key areas include implementing frameworks for AI and model-informed drug development, underpinned by global guidelines such as the ICH M15 draft.
Companies must adopt proactive measures to ensure explainability of AI-driven decisions and maintain lifecycle validation of models to meet regulatory requirements and protect patient safety. There is increased coordination among U.S. regulatory bodies but also divergence from international regulators, creating a complex compliance environment that demands constant monitoring and agility from companies.
European initiatives aim to foster innovation through strategies like the Biotech Act and streamlined market access while enhancing public trust and addressing misinformation. This chat promises to be a valuable resource for those looking to stay ahead of regulatory changes with sophisticated monitoring, agile compliance frameworks, and anticipation of emerging regulatory priorities in advanced technologies and market access.
Don't miss this opportunity to learn from industry experts and gain insights into the future of the life sciences industry. The chat will take place at Informa Connect's Transparency & HCP Engagement Conference.
[1] Increased regulatory complexity and the need for agile compliance frameworks - [Source] [3] European initiatives to foster innovation and address misinformation - [Source] [5] Expectations for effective compliance programs in the life sciences industry - [Source]
- The chat on "Enforcement Update - Examining Today's Regulatory Landscape and Emerging Trends" in the life sciences industry, hosted by Informa Connect, will shed light on theneed for agile compliance frameworks that adapt to increased regulatory complexity, significantly important in the domain of health-and-wellness.
- The European initiatives to foster innovation like the Biotech Act, coupled with strategies for streamlined market access and addressing misinformation, demonstrate a dedication towards medical-conditions and preserving public trust, illustrative of forward-thinking finance and business practices.
