Pre-Conference Short Courses
*Please note: Short Courses are stand-alone events. Registration for the main conference is not mandatory.
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 each Short Course!
Please note, all half day courses will be held virtually during the week of June 3-7 and June 10-12. Full day courses will take place in-person on Sunday, June 16 in San Diego, CA.
Short Course Registration Form
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Monday, June 3
#011A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials
Half Day Virtual | 9:30AM - 12:30PM ETStatistics and Data Science Track
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 can include commonly seen hypothesis test, survival analyses, regression modelling, 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.
#012P: A Guide to Plan and Implement a Clinical Research Data Integration Hub
Half Day Virtual | 1:00 - 4:00PM ETThis short course will help participants in better aggregating and harmonizing disparate data streams including EMR to EDC and Biomarkers to EDC streams. As Artificial Intelligence (AI) and Machine Learning (ML) programs become more prevalent, clinical research data scientists and clinical research operations will learn to identify and describe best practices in collecting, aggregating and harmonizing clinical research data.
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Tuesday, June 4
#021A: Signal Management in Pharmacovigilance
Half Day Virtual | 9:30AM - 12:30PM ETClinical Safety and Pharmacovigilance Track
This short course covers all aspects of the Signal Management process. The course is sub-divided into two modules:
- The first module discusses the Importance of robust and efficient Signal Management, and the Signal Detection step: we discuss definitions, applicable regulations, methodologies, quantitative v. qualitative techniques, and common datasets reviewed.
- The second module covers Signal Validation where the validation process, relevance, and possible conclusions shall be elaborated. Next, we discuss the Signal Assessment process in detail. We start with the various data-sources that can be evaluated and their relative importance, explain the formulation of the search strategy, and finally outline the key aspects of case assessment and literature summarization. We cover the basic structure of the Signal Assessment Report and discuss the importance of using multiple data sources for a comprehensive signal assessment. We end by touching upon various possible outcomes of the Signal Management process.
#022P: Business Acumen: Tools to Enhance Work Relationships
Half Day Virtual | 1:00 - 4:00PM ETProfessional Development Track
Newly promoted employees need help when transitioning into a manager or leader role. This short course will offer two tools for the first-time manager or team leader: Situational Leadership and Masterful Delegation.
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Wednesday, June 5
#031A: Bringing Together Multiple Sources of Evidence for Pharmacovigilance Evaluations
Half Day Virtual | 9:30AM - 12:30PM ETThis short course will provide an opportunity to understand the complementary nature of multiple evidence sources for pharmacovigilance evaluation and provide training on evidence synthesis methodology and how it can be applied to bring together data from multiple sources. During the course, we will focus on what evidence synthesis is and how it can be applied to your research, why we should bring together different sources of evidence, and why it is necessary to recognize the complementary nature of pharmacovigilance and pharmacoepidemiology (RWE).
#032P: Optimizing Clinical Trial Operations: Innovative Visual Analytics for Enhanced Study Planning, Safety Monitoring, and Data Exploration
Half Day Virtual | 1:00PM - 4:00PM ETStatistics and Data Science Track
Efficient study planning, safety monitoring, data exploration, reporting, and submission in clinical trials is a must. The traditional approach of using static tables, listings, and figures (TFLs) has many limitations and can be inefficient. This short course will present some innovative visual analytics approaches and open-source tools that facilitate for interactivity not only within the tool, but also in the outputs, allowing for efficient and informative data insights. This can greatly enhance planning, safety monitoring, data monitoring committee activities, and data exploration.
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Thursday, June 6
#041A: Digital Evolution in Healthcare: Navigating Data Standards for Global Interoperability
Half Day Virtual | 9:30AM - 12:30PM ETThis short course will offer participants a deep explanation of the data standards landscape, emphasizing how it will create a paradigm shift in managing, validating, exchanging, assessing, and making decisions, ultimately creating an interoperable global healthcare system. The course blends interactive sessions, case studies, and hands-on exercises, ensuring participants not only gain knowledge but also practical skills to drive global interoperability in their organizations.
#042: Revolutionizing Clinical Trial Reporting: Harnessing Visual Analytics and Open-Source Tools for Efficient Insights and Submissions
Half Day Virtual | 1:00PM - 4:00PM ETStatistics and Data Science Track
Efficient clinical trial reporting leveraging cutting edge tools in clinical trials is a must. The traditional approach of using static tables, listings, and figures (TFLs) has many limitations and can be inefficient. This short course will present some innovative visual analytics approaches and open-source tools that facilitate for interactivity not only within the tool, but also in the outputs, allowing for efficient and informative data insights in clinical trial reporting. This can greatly enhance quick creation and comprehension of topline presentations, benefit-risk assessment, reporting, and submissions.
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Friday, June 7
#051F: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations for Product Developers
Half Day Virtual | 9:30AM – 12:30PM ETCell 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. This short course will introduce CGT-specific requirements for each of the major disciplines for regulatory submissions: CMC, Non-clinical and Clinical. This short 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.
#052F: Unlocking Community Engagement: Understanding the Landscape, Budgets, and Metrics
Half Day Virtual | 1:00PM – 4:00PM ET
Professional Development Track
This short course will offer practical examples for engaging diverse communities. It aims to increase representation and improve health outcomes by developing thoughtful diversity plans with a community-based approach to clinical research. By addressing these barriers and building meaningful relationships, we can bridge the gap and ensure that underrepresented populations have equal access to clinical trials and the potential benefits it offers.
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Monday, June 10
#061: Innovate to Elevate: Leading and Developing a Critically Thinking Clinical Research Team
Half Day Virtual | 9:30AM – 12:30PM ETProfessional Development Track
This short course will enable leaders to accelerate the development of critical thinking skills across their organizations. Clinical Research Leaders are asking “how do I, as a leader, help improve critical thinking skills across my staff?” This short course is for those leaders. We start with the basics and deconstruct critical thinking into building blocks: 1) Answers to why we need to become better critical thinkers, 2) Delve into the problem solving and strategic aspects of critical thinking, and 3) Provide a systematic method for improving critical thinking skills. This first part of the short course serves as a foundation and provides Clinical Research Leaders with a common framework and lexicon for discussing and coaching critical thinking skill development within their organizations.
#062F: Estimand Framework Implementation
Half Day Virtual | 1:00PM – 4:00PM ET
Statistics and Data Science Track
This short course will introduce the estimand framework, provide tools to specify clinical questions of interest precisely and to facilitate cross-disciplinary collaboration, and highlights key concepts with illustrative examples. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued an ICH Harmonized Guideline: ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis. The US Food and Drug Administration adopted this as guidance in May 2021. The ICH E9 (R1) Addendum introduces the estimand framework for clinical trials to obtain relevant and interpretable treatment effects, which enable clear assessment of benefits and risks of treatments. The estimand framework is intended to facilitate the dialogue on drug/biologic development among review disciplines, as well as between sponsors and regulators.
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Tuesday, June 11
#071: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use
Half Day Virtual | 9:30AM – 12:30PM ETThis short course will provide an overview of how real-world evidence (RWE) is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use and how RWD/E is used earlier in clinical development. Following the major points from recently released guidance documents from around the world, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status when real-world studies will be sufficient to meet regulatory evidence requirements.
#72P: Protocol Development Best Practices using Estimand Thinking
Half Day Virtual | 1:00PM – 4:00PM ET
Clinical Trials and Clinical Operations Track
This short course will review current protocol templates in the public domain to share best practices in optimizing protocol design. The course will also summarize key elements from ICH guidances including ICH E9R1 to apply Estimand thinking for selecting the appropriate components of Estimands and strategies for handling of intercurrent events. Select examples of Phase 2 and 3 study protocols in the public domain that appropriately used Estimand thinking will be assessed, in addition to review protocols from recent approvals and failures for drugs and biologics to learn how to increase likelihood of success in your trials.
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Sunday, June 16
#92F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management
Full Day | In-Person | 9:00AM-5:00PM PTR&D Quality and Compliance Track
According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. In this workshop, we will demonstrate by interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, we will explore the challenges of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use some direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture.
#93F: Leadership Bootcamp
Full Day | In-Person | 9:00AM-5:00PM PTProfessional Development Track
Whether you are a manager, a team leader, or simply someone who wants to be more influential in your personal and professional life, this short course will help you develop the skills and knowledge you need to be an effective leader. You will have the opportunity to practice and hone your leadership skills and receive feedback from others. Identify your strengths and weaknesses as a leader and how to leverage them in your everyday life.
Short Course Registration Form