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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.

  • Full Day

    Interdisciplinary Safety Evaluation During Product Development

    June 23 | 9:00AM-5:00PM

    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.

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    Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop

    June 23 | 9:00AM-5:00PM

    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.

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    Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision-Making

    June 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.

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    Back to the Future: Combination Products in the 21st Century

    June 23 | 9:00AM-5:00PM

    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.

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    Scenarios for Complex Generic Drug Development: FDA and Pre-ANDA Interaction

    June 23 | 9:00AM-5:00PM

    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.

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