Preconference Short Courses
Receive $100 off of your DIA 2019 Global Annual Meeting registration by registering for two half-day short courses or one full-day short course. Purchases must be made at the same time in order to receive the discount.
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.
Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?June 23 | 9:00AM-12:30PM
Real world evidence (RWE) has the potential to compliment and extend the safety and effectiveness knowledge of drugs gained from RCTs. This short course will discuss key study design principles to guide evaluation of RWE using studies focused on cardiovascular safety assessments.
This course will review regulatory precedent (and the pathway to locate, assess, and integrate) as a global regulatory strategic driver.
This short course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates.
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.
Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues.
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.
This interactive short course, created in collaboration with the Critical Path Institute’s ePRO Consortium, will provide real world examples and case studies including challenges and proposed solutions for the audience to work through in small groups.
R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development LifecycleJune 23 | 9:00AM-12:30PM
This course is designed to provide participants with knowledge, case examples, and hands-on experience to design and implement a comprehensive quality strategy (CQS) and cross-functional framework to identify, manage, and communicate quality risks throughout the drug development lifecycle.
This course will specifically explore ML and its application within the PV regulatory landscape and provide a high-level introduction to ML, including tools and project tips. The core of the course will also dive deeper into applications within PV.
This short course focuses on how best to plan, manage, prepare, and execute successfully at EU high-stakes meetings. Former CHMP members, pharma executives, and communication specialists will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with EU regulators.
TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. During this short course, we 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.
Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical DevelopmentJune 23 | 1:30-5:00PM
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.
The DIA-ASA Biopharm Safety Evaluation Working Group is developing a series of novel interactive safety graphic tools to enhance the ability of safety and clinical development professionals to identify and evaluate safety signals. This short course will demonstrate the functions of the tool by way of case examples exploring various hepatotoxicity signals.
This short course is designed to teach participants a step-by-step approach to designing patient materials and educational initiatives that effectively communicate concepts at a level appropriate for their audiences.
This short course will provide a systematic, coordinated approach to identify, assess, and characterize safety topics of interest that enables investigators to develop clinical as well as quantitative understanding of the safety profile. It will present the work that has been done by the DIA-ASA Interdisciplinary Safety Evaluation scientific working group, TransCelerate, and ICH.
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. 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.
Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision-MakingJune 23 | 9:00AM-5:00PM
This short course is designed as an introduction to a range of stated-preference methods and the application of these methods in drug development, regulatory decision-making, and patient advocacy. It will include hands-on exercises and detailed case studies of recent empirical examples to illustrate concepts.
This short course provides an overview and comparison of drug, device, and biologics regulation in the US and EU, and the intersect that defines how combination products fit within these regulations. The course will be interactive. Case studies will be presented, but you are also encouraged to ask questions and share your own examples of challenges and successes.
This practical, active-participation workshop will help participants learn how to approach a demonstration of active pharmaceutical ingredient sameness and bioequivalence for each type of complex generic drug products and how to engage with the FDA about different types of questions during the development of a CGDP.