Preconference Short Courses
Short Courses are designed to enhance your knowledge in both broad and specific areas to enhance and 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!
Monday, June 13
#011A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save YouHalf Day | 10:00AM - 1:00PM ET
The intent of this short course is to provide a quick overview and practical insight into locating, analyzing and applying precedent as an aid to making better strategic regulatory decisions. In a rapidly evolving regulatory environment of drugs and biologics, it is critical for regulatory professionals to employ research skills in locating precedent, determining those that are deemed meaningful and discarding those that are misleading, and developing an understanding of the bigger picture as a critical deliverable in a time of data-driven decision-making.
#012P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands!Half Day | 2:00 - 5:00PM ET
This presentation will review fundamentals of estimand frameworks for those involved with developing clinical trial protocols. Example estimands pertaining to different indications will be reviewed. The presentation will also suggest ways to improve understanding of estimands as statisticians communicate the concepts of ICH E9 R1 to non-statisticians.
Tuesday, June 14
#021A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical TrialsHalf Day | 10:00AM - 1:00PM ET
In this workshop, participants will be introduced to common statistical methods applied to specific outcomes and their results. Some examples of potential statistical concepts include commonly seen hypothesis tests, 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.
This short course will explore machine learning (ML) within the Regulatory/ Pharmacovigilance (PV) landscape. The instructors will provide a high-level introduction to machine learning, including common tools and project tips. We will then evaluate example applications, such evaluation of Single Case Drug-Event-Pair (DEP) causality using the Modified Naranjo Causality Score for ICSRs (MONARCSi).
This 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, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December 2019, 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 of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements, including highlights from the recent draft guidance documents in 2021. Although much of the focus will be on FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data.
Wednesday, June 15
Navigating a global advertising and promotion function can be challenging. Creating a compliant and flexible process while bearing in mind regional and country differences along with ensuring processes are not “US-centric” is a common challenge faced by sponsors. Focusing on the EU and Canada, this session will address the foundational regulatory and legal requirements, provide insights into best practices for a global adpromo process, and using case studies and examples, highlight key pitfalls and how to overcome them. The presenters will address the biggest questions faced by sponsors today (eg, direct to consumer messaging, press releases, social media, advertising and promotion v. information, corporate websites) to ensure the development of globally compliant materials while reducing burden on the company.
#032A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development LifecycleHalf Day | 10:00AM - 1:00PM ET
The short course will provide an overview of the development of a cross functional quality strategy framework in an R&D QA organization which, when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Business and operations risks are not addressed in this course. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections. The value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.
#033P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical UsesHalf Day | 2:00 - 5:00PM ET
This session will share key findings that the framework synthesized and discuss practical use cases, such as how it can be used to upskill and educate safety professionals within biopharma organizations. By leveraging this framework, participants will be able to incorporate these key findings and considerations into their organizations and better operationalize the presentation of safety information in key documents.
Thursday, June 16
#041A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical DevelopmentHalf Day | 8:00 - 11:00AM ET
Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan, as well as global development programs. This course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), as well as the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.
With a growing industry trend to incorporate decentralizing solutions in trial design, what does it really mean to run a Decentralized Clinical Trial, and how is it any different from running traditional clinical trials? This sessions answers what new technologies are needed and explains how to navigate new process requirements for technological advancements and organizational structure changes. You will learn the foundational elements of designing decentralized clinical trials/hybrid trials, and how these advancements in trial design impact all stakeholders involved, including the patient, sponsor, and site.