Pre-Conference Short Courses
Join us virtually prior to the meeting on June 12-15 and/or join us for our in person full day short courses on June 25.
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 12 – 15. Full day courses will take place in-person on Sunday, June 25 in Boston, MA. All times are in EDT.
Short Course Registration Form
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Monday, June 12
#011A: 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 is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, but the approaches described here are useful for health technology assessments for payers. 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.
#012P: Understanding the Bayesian Approach in Decision Making for Anyone Involved in Clinical Trial Design or Interpretation
Half Day Virtual | 1:00 - 4:00PM ETThis short course will introduce common basic concepts in Bayesian approaches through graphical illustrations and examples in non-statistical language for anyone involved in clinical trials or research studies. Group activities and polls will be designed for interactive learning throughout the course.
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Tuesday, June 13
#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 three 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, in the third and final module. 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.
We do not aim to have an entirely theoretical discussion on this complex topic: illustrative examples will be described to illustrate how the principles discussed are put into practice.At the end of the course, participants can expect to have a good understanding of Signal management from a theoretical and practical standpoint.
#022P: Global Labeling – The Basics of Core Datasheet
Half Day Virtual | 1:00 - 4:00PM ETRegulatory Track and Clinical Safety and Pharmacovigilance Track
This short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, and how local labeling changes and regulatory requirements may have an impact on CCDS. In addition, we will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments.
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Wednesday, June 14
#031A: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations
Half Day Virtual | 9:30AM - 12:30PM ETRegulatory Track and Translational Sciences and Precision Medicine 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. The course will outline some of the global regulatory frameworks that have been put in place to specifically address the needs of CGTs. It will then introduce CGT-specific 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. Biological mechanisms for CGTs will also be discussed, with a focus on how mechanistic understanding can inform the design of in vitro and animal studies to provide Non-clinical evidence of safety and efficacy. Key principles for clinical development of CGTs will be presented, with an emphasis on clinical study design elements that are critical for Health Authority evaluation of benefit-risk. Expedited development programs and early engagement opportunities for CGTs will also be covered. The presenters include ex-Health Authority Regulators who have a combined 30 years of experience in FDA, EMA, NMPA/CDE.
#032P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials
Half Day Virtual | 1:00PM - 4:00PM ETStatistical 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 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.
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Sunday, June 25
#051F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Full Day In-Person | 9:00AM - 5:00PM ETR&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 short course, 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 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.
#052F: Ecosystem of Digital and Data Innovation Partnerships: Generating Regulatory Grade Evidence in Diverse Patient Populations
Full Day In-Person | 9:00AM - 5:00PM ET
Generating regulatory grade evidence in diverse patient populations in a priority focus in biopharma now that the bill has been passed December 2022. With the US legislation of the 21st Century Cures Act and 2022 DEPICT Act, designing clinical trials with increased access to care in a cost-effective method is a significant strategy for biopharma organizations. In this short course, we will include perspectives shared across collaborators from a DCT Vendor, RWE Data, CRO, BIoPharma that outline solutions to address the recent regulatory and policy guidance on diversity and digital engagements with patients.
Short Course Registration Form