Preconference Short Courses
Join us prior to the meeting on June 21-25
Short Courses are designed to enhance your knowledge in a broad or specific area for your day-to-day job function. Short Courses are an additional fee to the meeting registration cost. Note all times are in EST.
Monday, June 21
This half-day 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.
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. 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.
#013A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save YouHalf Day | 10:00AM-1:00PM ET
This 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, 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.
Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon.
This half day short course will focus on applying FDA guidance related to safety considerations for proprietary names, container labels, carton labeling, and product design to minimize medication errors. The course will use a case-based instructional model to cover best practices for developing proprietary names, designing labels and labeling, and constructing user interfaces and container closures.
Tuesday, June 22
#021A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development LifecycleHalf Day | 10:00AM-1:00PM ET
Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management.
#022A: Medical Writing Training Programs: Teaching the Next Generation of Regulatory Medical WritersHalf Day | 10:00AM-1:00PM ET
How can we better train regulatory writers to acquire the skills needed to successfully do their jobs? The importance of standardized training programs for regulatory writers will be discussed, along with experiences developing training programs.
#023P: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable ModelHalf Day | 2:00-5:00PM ET
Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality risk-based monitoring (RBM). To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices, and lessons learned from member companies adoption experience, all of which are publicly available. This short course will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.
This short course will include new approaches to document review and finalization that are urgently needed. There are tools and techniques that can be used to make document review more effective and thus produce higher quality clinical documentation in shorter times.
This short course focuses on how best to plan, manage, prepare, and execute successfully at EU high-stakes meetings. A former CHMP member and a communication specialist will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with regulators. We will discuss how best to present your key massages and supporting slides and manuscript. This short course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these.
Wednesday, June 23
Throughout the course, we cover lessons learned over the last decade of REMS implementation, and how implementation approaches continue to evolve to support safe use and product access, while reducing overall burden of REMS on the healthcare landscape. Using examples from approved REMS programs, we explore how key concepts are applied in the real world. By the end of this course, you will have an expanded understanding of REMS and the knowledge necessary to be involved in development, approval, implementation, and/or administration of a REMS program.
The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.
#033P: eCOA 102: Beyond the Basics - Operational, Scientific, and Best Practices for eCOA and Wearable Devices in Clinical TrialsHalf Day | 2:00-5:00PM ET
Capturing clinical outcome assessment data electronically (eCOA) brings many benefits over traditional paper-based methodologies. However, uncertainty and barriers to adoption still remain. This may be due to challenges with poor experiences during study start-up, conduct or close out, absence of clear definitions of roles and responsibilities among sponsors and providers, and misalignment of expectations among all stakeholders. Scientific and regulatory thinking, particularly in relation to issues of translation of measures and comparability of modes of data collection, can also create significant confusion, not helped by the fact that recommendations relating to these topics are evolving over time. Finally, a whole new area of technology-driven outcomes, namely those supported by mobile sensors and wearable devices, is emerging, raising a host of new questions and challenges for study teams.
Most people think they are effective communicators, but how many of us are truly impactful in our communication? This short course will focus on the best practices for effective business communication using the mnemonic “CATCH’EM”. Real life examples will be discussed, and role play will be used to enforce concepts and deepen understanding.
According to FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. This short course will demonstrate by using 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, challenges will be presented 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.
Thursday, June 24
#041A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical DevelopmentHalf Day | 10:00AM-1:00PM 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 short 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), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation, and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.
In this course, we will provide an overview of this emerging technology: how it is being used in healthcare and life sciences, where it is being explored for future use, how it operates from a non-technical perspective, and the risks, benefits, and trade-offs of its use in the life sciences.
What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings.
A 2019 Standish Group Chaos Study shows that project management teams succeed 26% of the time, 53% of the time projects are late or over budget, or 21% of projects fail. This course examines how collaboration is one factor impacting the success and failure of life sciences global teams.
Friday, June 25
New Drug Administration Law and more than 100 regulations, guidance, policies, and implementing rules are effective in 2020. The framework for regulatory oversight of China’s National Medical Products Administration (NMPA) and NMPA’s Center for Drug Evaluation (CDE) has changed significantly in the decision-making for the supervision and administration of drugs, and in the evaluation of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications. This short course will highlight most relevant requirements and regulatory strategy to submit IND/NDA in China and discuss how to interact with NMPA/CDE effectively in the submission and approval process.
This short course will provide a structured approach for exploring upskilling your organization in a highly technical world. Many of the data review and verification systems and processes either no longer scale, due to new data sources, or are too expensive for their limited value. This short course will be interactive and leverage real world examples as exercise. We will have a mixed format of presentation, small group exercise, and wrap up activities.