Preconference Short Courses
Short Courses are designed to enhance your knowledge in both broad and specific areas to improve your day-to-day job function. You can add Short Course offerings for an additional fee to your Global Annual Meeting registration or register for them as standalone events. Both ways offer savings! Register for two or more Short Courses and receive $50 off your total purchase!
Please note, all half-day courses will be held virtually during the week of June 9-12. Full day courses will take place in-person on Sunday, June 15 in Washington, DC.
Short Course Registration Form
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Monday, June 9
#12P : Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration
Half Day Virtual | 1:00 - 4:00PM ET
This short course will provide an overview of the current use of real-world data (RWD) and real-world evidence (RWE) for evidence generation in major markets, with a primary focus on regulatory use and how it can inform clinical development planning. Following the major points from recently released guidance documents from around the world, the course will explain how the fitness of evidence from RWD are assessed for any use case, key elements of design and analysis, and the current status for when real-world studies will be sufficient to meet regulatory evidence requirements.
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Tuesday, June 10
#21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol
Half Day Virtual | 9:30AM - 12:30PM ETClinical Safety and Pharmacovigilance Track
R&D Quality and Compliance Track
In this short course, participants will gain hands-on experience in applying Risk-Based Quality Management (RBQM) principles, grounded in the Quality by Design (QbD) framework, to real-world clinical trial scenarios. Working in small groups, participants will analyze a three-page real-life study synopsis, using guidance from ICH E6(R2/R3), to identify critical data, critical processes, and potential risks. Following an instructor-led introduction to key concepts like risk scoring and mitigation strategies, participants will identify and prioritize risks, create actionable risk statements, develop mitigation plans, define Key Risk Indicators (KRIs), and establish Quality Tolerance Limits (QTLs).
#22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development
Half Day Virtual | 1:00 - 4:00PM ETClinical Trials and Operations Track
Project Management and Strategic Planning Track
Professional Development Track
This short course provides a focused, in-depth exploration of how established project management frameworks, tools, and best practices can be applied specifically to the drug development process. Participants will begin by examining a range of methodologies—such as Agile, Waterfall, and hybrid approaches—to understand which strategies work best for managing the multifaceted challenges of clinical trials. Through guided instruction, attendees will learn how to adapt these methodologies to meet stringent regulatory requirements, handle complex demands, and maintain stringent quality standards.
In addition to foundational methodologies, this course delves into practical tools and templates that streamline project planning, risk management, and communication. These tools help teams navigate the intricate timelines associated with bringing a drug to market, enabling participants to anticipate and mitigate risks before they become obstacles. By learning to identify common bottlenecks and implement effective contingency plans, attendees can keep projects on schedule and budget, ensuring that new therapies reach patients faster.
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Wednesday, June 11
#31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations
Half Day Virtual | 9:30AM - 12:30PM ETClinical Trials and Operations Track
Regulatory CMC and Product Quality Track
Cell and Gene Therapies (CGTs) are a rapidly expanding area in the pharmaceutical sector, offering the potential to address serious unmet medical needs in many indications. Yet some of the conceptual frameworks in this field differ dramatically from those of traditional pharmaceutical medicines, specifically with regard to CMC, Non-clinical and Clinical requirements and Health Authority expectations. This short course will help those who have pharmaceutical sector experience but are newcomers to the CGT field ‘get into the right frame of mind’ to think about CGT development. Participants will be introduced to requirements for each of the major disciplines for regulatory submissions: CMC, Non-clinical and Clinical. The course will also explain the rationale behind the CMC approach to CGT manufacture and basic CMC regulatory expectations for CGT products, including process and product characterization, comparability and process validation.
#32P: Introduction to Artificial intelligence (AI) Regulations and Governance for Life Sciences
Half Day Virtual | 1:00PM - 4:00PM ET
This short course will provide an overview of major regulations and regulatory frameworks of major world health authorities around the use of Artificial intelligence (AI)/GenAI in the life sciences industry. It will cover the ethical, legal, and practical aspects of AI implementation, focusing on compliance with current and emerging regulations. It will introduce concepts of the AI Risk Management Framework (RMF) by National Institute of Standards and Technology and explore how they can be extended to AI governance within the life sciences industry. It will provide some ideas on how to implement AI governance processes for the implementation of projects and ongoing maintenance.
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Thursday, June 12
#41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials
Half Day Virtual | 9:30AM - 12:30PM ETStatistics and Data Science Track
Statistical methods are a powerful tool used in clinical trials to assess whether the data support evidence of a treatment effect. It is therefore key that the results of any statistical analysis are interpreted correctly. However, understanding and interpreting statistical results can be challenging for non-statisticians.
In this short course, participants will be introduced to common statistical methods applied to specific outcomes and their results. Some examples of potential statistical concepts to be covered include commonly seen hypothesis test, survival analyses, regression modelling, mixed models for repeated measures (MMRM), and adjusting for multiplicity. Important concepts such as p-values will be explained fully. Idealized examples as well as examples from publicly posted FDA reviews and results on clinicaltrials.gov will be used.
#42P: Regulatory Strategy Development for Complex Devices and Combination Products
Half Day Virtual | 1:00PM - 4:00PM ETPersonalized Medicine, Combination Products, and Diagnostics Track
Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. Implementation of a strategy includes the compilation of the plans and/or documents pertaining to strategic partnerships, intellectual property (IP) initiatives, product development approaches, quality management systems (QMS) optimizations, and regulatory submission plans into the integrated regulatory strategy for the complete “asset” as the traditional “ways of working” and/or processes will be challenged when developing an innovative combination product. This short course will explore key challenges and opportunities, offering practical exercises and a structured framework for success. It will focus on mitigating regulatory risk(s) in submissions timeliness and addressing issues such as excessive queries from health authorities, additional testing needs, and delays that impact time to market.
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Sunday, June 15
#61F: Root Cause Analysis and CAPA Management: Your Essential Toolkit for Best Practices
Full Day In-Person | 9:00AM – 5:00PM ETR&D Quality and Compliance Track
According to the FDA (as well as other regulators), corrective and preventive action (CAPA) management and lack of proper investigation of challenges is a top observation among companies in the industry. In this short course, through interactive case studies, participants will learn how to conduct a proper investigation into a robust root cause analysis using industry standard tools in a toolkit approach. Additionally, participants will explore the challenges of proper CAPA planning and define appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. Real-life case studies from various FDA 483s will be explored to showcase how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture
- Selecting, adapting and developing patient-reported outcome measures to meet protocol objectives
- The case for ePRO – when to select an electronic approach, and when paper might suffice
- ePRO implementation best practices to ensure good measurement science
- Migration validity considerations and evidentiary requirements
- Language, translation and licensing considerations
- Implementation steps including vendor selection and user acceptance testing (UAT) best practices
- Modality choices – web vs app, and bring-your-own-device (BYOD) considerations
- Hot topics such as data change processes, mixing modes, special populations, etc.
- Q&A – discussion of participants' own hot topics
#62F: Electronic Patient-Reported Outcomes (ePRO): An Implementation Masterclass
Full Day In-Person | 9:00AM – 5:00PM ET
Clinical Trials and Operations Track
Patient experience data, through patient-reported outcomes (PROs) and other clinical outcome assessments (COAs) are an increasingly important component of regulatory drug submissions and health technology assessments (HTAs). Instructors will take participants on an in-depth evaluation of the key topics important in successful ePRO implementation, including:
This short course will use tried and tested interactive workshop exercises and practical case studies to provide engaging ways of learning.
Short Course Registration Form