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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

  • Tuesday, June 4

    #021A: Signal Management in Pharmacovigilance

     

    GAM23

    Half Day Virtual | 9:30AM - 12:30PM ET

    Clinical Safety and Pharmacovigilance Track

    This short course covers all aspects of the Signal Management process. The course is sub-divided into two modules:

    1. 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.
    2. 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.

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    #022P: Business Acumen: Tools to Enhance Work Relationships

     

    GAM24


    Half Day Virtual | 1:00 - 4:00PM ET

    Professional 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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  • Friday, June 7

    #051F: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations for Product Developers

     

    GAM23

    Half Day Virtual | 9:30AM – 12:30PM ET

    Regulatory 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. 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.

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  • #052F: Unlocking Community Engagement: Understanding the Landscape, Budgets, and Metrics

     

    GAM23

    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

     

    GAM23

    Half Day Virtual | 9:30AM – 12:30PM ET

    Professional 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.

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  • #062F: Estimand Framework Implementation

     

    GAM23

    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

     

    GAM23

    Half Day Virtual | 9:30AM – 12:30PM ET

    Regulatory Track

    This 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.

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  • #72P: Protocol Development Best Practices using Estimand Thinking

     

    GAM23

    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

    #91F: From Insights to Impact: Enhancing Diversity in Clinical Trials and Transforming Organizational Practices

     

    GAM23

    Full Day In-Person | 9:00AM-5:00PM PT

    Clinical Trials and Clinical Operations

    This short course will address the strategies, policies, barriers, challenges, and unmet needs associated with diversity in clinical trials. Dive deep into the intricate world of clinical trial diversity and explore strategies, policies, and innovative breakthroughs that are reshaping the landscape. Featuring experts who will provide overviews of key topics and share their failure and success stories, this short course will encourage collaboration and the open exchange of ideas. These collective conversations will serve to generate innovative solutions and address relevant concerns related to increasing diversity in clinical trials.

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  • #92F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management

     

    GAM23

    Full Day | In-Person | 9:00AM-5:00PM PT

    R&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.

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    #93F: Leadership Bootcamp

     

    GAM23

    Full Day | In-Person | 9:00AM-5:00PM PT

    Professional 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.

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