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Short Courses & Professional Development

DIA offers two types of professional development at the Global Annual Meeting.

Short Courses are designed to enhance your knowledge in a broad or specific area for your day-to-day job function. Many of the courses offered are modeled off of and modified from a full DIA training. Short Courses are an additional fee to the meeting registration cost.

Professional Development opportunities are available to enable attendees to learn skills needed to expand their network, initiate challenging conversations, solve problems at work, and more! Professional Development sessions are part of the meeting registration fee.

Half Day

  • Leadership: How to Organize and Lead People in a Work Group

    June 18, 8:30AM-12:00PM

    This short course is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and want to learn how to exert influence on group behavior. This course will also benefit individuals to whom project managers report.

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  • Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory

    June 18, 8:30AM-12:00PM

    What are the common mistakes and solutions in the areas of drug development planning, regulatory agency interactions, and regulatory document writing? Practical advice for each of these areas will be presented, with an emphasis on learning from past examples that illustrate approaches to adopt or to avoid.

    Want a more comprehensive overview in Drug Development? Check out DIA’s eLearning program, accessible 24/7 for up to one year, with six modules in Drug Development and Life Cycle Management.

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  • How to Prepare for an FDA Inspection

    June 18, 8:30AM-12:00PM

    Designed for quality assurance (QA) and clinical staff in companies, as well as professionals working in pharmaceutical/biological companies that are involved in clinical trials and QA activities for clinical research, this course will provide information on how to build quality into a clinical trials program. A record number of FDA inspections, both domestic and international, and OHRP audits have resulted in an increased number of warning letters to sponsors, principal investigators, and IRBs.

    Want training sooner? Join us June 6-8 for a quick course from your office for the online version of How to Prepare for a Safety Inspection.

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  • Signal Detection: Identifying and Managing Safety Signals

    June 18, 8:30AM-12:00PM

    Join us for a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. There will be an emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The short course also provides participants with the context to evaluate new research in the field.

    This short course is a modeled off of and modified from the full DIA training, Introduction to Signal Detection and Data Mining held in Washington, DC, April 7 or online July 24-27.

    DIA also offers an Advanced Signal Detection Training in Washington, DC, October 2-3.

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  • The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment

    June 18, 8:30AM-12:00PM

    Hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the course will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives.

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  • Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China

    June 18, 8:30AM-12:00PM

    The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. Since 2015, Chinese GCP guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some good clinical practices (GCP) are overturning common ways that were implemented since 2003. The CFDA is updating the drug category and IND/NDA process for the regulatory registration purpose, and enhancing inspective forces on the quality and integrity of clinical trial outcomes. The procedures of IND/NDA review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug R&D strategies in China. This course will provide insights into critical considerations impacting IND/NDA practices involving drugs development in China and current CFDA reformations of regulatory submission review and approval.

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  • Smart, Innovative Risk-based Auditing: Shifting the Paradigm

    June 18, 8:30AM-12:00PM

    Learn what regulators are looking for from sponsors and CROs as they initially assess their vendors and audit investigator sites for compliance and oversee them for compliance and quality throughout the clinical trial. As clinical trials become more complex involving additional data and vendors, why is it that companies keep using the traditional audit plan? As technology has provided the transparency and tools needed for trending, review and analytics, why is it that companies have yet to evolve to utilize them? Discuss various risk-based methodologies for audit programs and how logistical issues such as governmental travel advisories, environmental travel restrictions, resource issues (such as timing, budget) and availability of qualified individuals (auditors) may necessitate innovation to accomplish audit goals. Discuss case studies to assess risk in various remote auditing options which may provide a snapshot of compliance when travel may not be possible at that time and may assist in training auditors or providing subject matter expertise as needed from statisticians, IT professionals, etc. Learn methods for selecting what to audit and to what extent the auditing should be performed based on factors which may contribute to, or increase/decrease risk to subject safety and rights or data quality/integrity.

    Produce an audit plan that can be adapted for use to qualify (initial and re-qualification) and audit vendors (CROs, pharmacovigilance, eCOA vendors, etc.), study sites, and internal processes (when the department is off-site). Use the plan for auditing study site data, trial master files (TMF), databases, imaging data, etc.

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  • Preparing for a US FDA Advisory Committee Meeting

    June 18, 1:00-4:30PM

    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.

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  • Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation

    June 18, 1:00-4:30PM

    This course is designed to help you understand what culture, bureaucracy and innovation really are, and the impact they can have on actual business results — in concrete, clear terms. This requires stripping away the vagueness and assumptions that so commonly surround these topics. The discussion will include three primary components: understanding and influencing workplace culture and its impact on employee results, how to avoid and deal with workplace bureaucracy, and how to understand and encourage workplace innovation.

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  • Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

    June 18, 1:00-4:30PM

    Participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role play as key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs, with an emphasis on providing a timely, high-quality deliverable.

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  • Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

    June 18, 1:00-4:30PM

    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.

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  • Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

    June 18, 1:00-4:30PM

    The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality 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.

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  • Digital Health Technologies for Combination Products and Beyond: Development and Regulation

    June 18, 1:00-4:30PM

    This short course will focus on how digital health technologies are being developed and regulated in the pharmaceutical/combination products space. Although many digital health technologies follow a fairly straightforward regulatory path as devices, those that interact with drug products often encounter more regulatory uncertainty. FDA’s policy on how mobile medical apps, clinical decision support software, and wearables can be combined with pharmaceutical use is still in development, so it is often difficult to navigate the regulatory path to market for these products. This course will look at currently available FDA guidances and what they mean for digital health products that combine both a drug and device. Participants will explore how to work with FDA when developing digital health technologies that may veer outside of established regulatory pathways, and a series of case studies will examine how innovators have addressed development and regulatory hurdles.

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  • Developing and Implementing the Issue Management Framework Developed Through TransCelerate

    June 18, 1:00-4:30PM

    This short course will be a highly interactive where participants will examine a conceptual framework for effectively managing the challenges associated with issue management in the clinical development space. Principles and expectations of ICH E6 R1, R2 will be included as appropriate. The course will begin with identifying the benefits of a framework with a proactive approach for end-to-end management of issues including a triage mechanism, effective use of CAPA methodology with a new focus, and methodologies for trending and analytics that will signal potential risks and drive continuous improvement. Based on the knowledge received, participants will have the opportunity to have a “hands-on” experience in developing a framework from hypothetical case studies developed for the purpose for this short course. The hands-on experience will include development of thresholds for triage, CAPA design, and trending leading to analytics with a special segment on predictive analytics. Lastly participants will have an opportunity to learn from the instructor’s approaches to getting started in their institutions.

    In 3.5 hours, participants will leave with knowledge and access to material developed during a 24 month journey with a cross-function team from pharma industry participating in a TransCelerate Clinical QMS Initiative for Issue Management.

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  • To Change or Not to Change, That is the Career Question: Knowing When it’s Time to Move On (Not, Run From)

    June 18, 2:45-4:00PM

    Hear from industry leaders on how and when they knew it was time to make a career change and how to prepare for the move. Learn techniques you can use to assess a negative performance review, being passed over for a promotion, and how to avoid an emotionally-based (and regretful) decision.

    Learn ways to turn negative career experiences into a positive springboard forward and gain personal insights on what it takes to make a change!

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  • Networking Within Your Company

    June 18, 4:15-5:30PM

    Recognize the importance of networking within your company as a part of career management! Even if your job rarely requires you to interact outside your company, you still need to know how to network, both internally and externally. Different types of networking will be explained, as well as an understanding of the proper way to execute. There will be discussion of personality types and how that impacts networking. There will also be a portion of the workshop dedicated to practicing your new networking skills!

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Full Day

  • Clinical Statistics for Nonstatisticians

    June 18, 9:00AM-5:00PM

    This short course will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the course will be on the application of statistical concepts to clinical investigation.

    This short course is a modeled off of and modified from the full DIA training, Clinical Statistics for Nonstatisticians, held in Boston, MA, August 14-15.

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  • A Rare Disease Program Case Study: Strategies for Successful Outcomes

    June 18, 9:00AM-5:00PM

    Working through a multifaceted case study, this one-day, intensive workshop will address ‘heads-on’ the unique challenges associated with the development of rare disease therapies. Successful outcomes are a direct result of early planning, design and engagement with patients, patient advocacy groups, treating physicians, specialists, and regulators. This interactive case study will emphasize how “spending” time in early planning assures appropriate study outcome measures, timely enrollment of clinical trials and successful regulatory interactions which affect the bottom line and improve the potential for developing therapies for rare disease patients faster.

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  • Analysis of Safety Data from Clinical Trials

    June 18, 9:00AM-5:00PM

    This short course is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

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  • The Good Pharmacovigilance Practices in the EU: Global Applications

    June 18, 9:00AM-5:00PM

    The objective of this short course is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:

    • Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems
    • Management and reporting of adverse reactions and signal management
    • Updates of GVP Module VI
    • The new EU E2B(R3) ICSR implementation guide
    • New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA
    • Updates to the EudraVigilance Access Policy

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  • DIA Drug Development and Life Sciences Career Fair

    June 18-19, 10:00AM-5:00PM

    Building on its Career and Professional Development resources, DIA will be hosting its first ever complimentary Career Fair during the DIA 2017 Global Annual Meeting.

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