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What is happening at Global Pharmacovigilance and Risk Management Strategies Conference

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Gain insights into key global pharmacovigilance and risk management updates from regulatory bodies in the US, Europe, UK, Asia, and other regions, all at one single location
Stay informed on the latest regulatory guidances, including REMS, aRMMs, and benefit-risk assessment frameworks
Engage with like-minded professionals through interactive sessions, featuring real-world case studies, regulatory updates, and pharmacovigilance success stories
Network with solution providers to discover innovative tools and technologies that can enhance and streamline your pharmacovigilance operations, including AI applications and predictive technologies
Explore high-end stores and decadent restaurants in the eclectic city of Baltimore!

Network with peers and industry leaders in pharmacovigilance and drug safety to discuss best practices and shared challenges amongst your organizations
Participate in interactive sessions on pressing topics like risk management convergence, AI in pharmacovigilance, and hepatic drug safety considerations for complex cases
Evaluate the application of different technologies, such as knowledge graphs, machine learning, and AI for signal detection and benefit-risk assessment
Hear from global regulatory authorities on the latest pharmacovigilance guidances and harmonization efforts to ensure compliance and stay current in an evolving regulatory landscape

Short Course: Aggregate Safety Assessment Planning (ASAP) Process

January 26, 2025 – 9:00AM ET – 4:00PM ET | In-person
*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
This full-day in-person short course.
An Aggregate Safety Assessment Planning (ASAP) process is critical to ensure appropriate collection and assessment of product level data and to answer key safety questions from various stakeholders. In addition, the ASAP process strengthens safety signal detection as well as risk identification and management. The American Statistical Association Biopharma Safety Scientific Working Group has proposed an ASAP template to guide sponsor teams in clinical development. This session will describe how the ASAP supports multidisciplinary safety planning, ongoing aggregate safety evaluation, IND safety reporting decisions, and evaluation of product level safety data and the Safety Topics of Interest, which have the potential to influence a product’s benefit: risk assessment.

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Short Course: Introduction to Statistics in Drug Safety

January 26, 2025 – 1:00 ET – 4:00PM ET | In-person
*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
This full-day in-person short course.
This (mainly) formula-free half-day course will introduce a systematic approach for evaluating and assessing adverse events and other safety information, guided by medical judgment, which enables investigators to develop clinical as well as statistical understanding of the safety profile.

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Case Study Spotlights

From concept to execution, each spotlight offers a deep dive into the design process, outlining how we tackle complex challenges and deliver measurable success.

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