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Short Course [clear filter]
Sunday, June 23
 

9:00am

SC20: #20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

This 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 the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies;
  • Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments;
  • Recognize when RWE based approaches are of sufficient quality to enable decision making.



Speakers
avatar for Brian Bradbury

Brian Bradbury

Executive Director & Head, Data and Analytics, Center for Observational Research, Amgen, Inc.
Brian D. Bradbury is Executive Director in the Center for Observational Research (CfOR) at Amgen, Inc, and an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who use real-world data (RWD) to... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer & Senior Vice President, IQVIA
Nancy Dreyer is chief scientific officer and SVP at IQVIA. She focuses on generating real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional approaches. She is a Fellow of both DIA and the Int’l Society of Pharmacoepidemiology... Read More →
avatar for Jessica Franklin

Jessica Franklin

Assistant Professor of Medicine, Div of Pharmacoepidemiology and Pharmacoeconomi, Brigham and Women's Hospital and Harvard Medical School
Jessica Franklin, PhD, is an Assistant Professor of Medicine at Harvard Medical School and biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on developing and applying statistical methods for the study... Read More →
avatar for Paul Muntner

Paul Muntner

Professor of Epidemiology and Associate Dean for Research, University of Alabama at Birmingham
Paul Muntner is Associate Dean for Research and Professor of Epidemiology at the University of Alabama at Birmingham. He earned a Master’s degree in biostatistics and a doctorate degree in epidemiology from the Johns Hopkins University. Since 2014, he has served as Co-Director of... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:00am

SC27: #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-507-L04-P; CME 3.25; IACET 3.25; RN 3.25

Evidence suggests that capturing clinical outcome assessment data electronically (eCOA) has many benefits over paper. However, barriers to adoption still remain. Poor adoption is in part attributable to unfamiliarity with benefits, but also poor experiences during study start-up, absence of clear expectations among sponsors and vendors, and misalignment among all stakeholders. This is also an area where no formal training exists for sponsors or eCOA providers. This short course is designed to introduce participants to key eCOA topics including:
  • Benefits of and barriers to eCOA adoption
  • Regulatory guidance applicable to eCOA vendors
  • Key measurement science and design principles applicable when using eCOA
  • Considerations when choosing a solution for your study based on study design and patient population
  • Start-up processes and considerations for migrating from paper to electronic modes of data collection, developing specification documents, and conducting user acceptance testing
  • Role of sponsors and sites in the trial technology implementation process and in optimizing quality of data collected with eCOA
  • Best practice recommendations for training site staff and study subjects on eCOA data collection in clinical trials
  • Considerations for the use of bring your own device (BYOD) in clinical trials
The 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.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals in the clinical operations, digital technologies, procurement, clinical science or outcomes research areas at pharmaceutical companies who are considering collection of eCOA data or evaluating eCOA technology providers for their clinical studies. eCOA provider staff and developers new to the field would also benefit from this course.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Review benefits and challenges of capturing eCOA data in clinical trials;
  • Identify measurement science principles applicable to eCOA data capture and considerations for measurement comparability;
  • Discuss roles and responsibilities of eCOA providers, sponsors and sites in the implementation/deployment of clinical trials collecting electronic COA data.



Speakers
avatar for Paul O'Donohoe

Paul O'Donohoe

Scientific Lead, eCOA and Mobile Health, Medidata Solutions
Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company's scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and supports... Read More →
avatar for Susan Vallow

Susan Vallow

Executive Director, Patient-Centered Outcomes Research, Worldwide Clinical Trials
Susan Vallow, VP, Patient Centered Outcomes Strategy, MedAvante-ProPhase, is an experienced outcomes researcher with a specialty in the strategy, development and implementation of PROs. Sue previously was Senior Director & Head, Patient Focused Outcomes at GSK, where she managed the... Read More →
avatar for Patricia DeLong

Patricia DeLong

Manager, Patient-Reported Outcomes, Janssen Global Services, LLC
Patricia (Trish) Shepherd Delong has worked in the PRO and eCOA fields for more than ten years in both contract research and pharmaceutical organizations. She currently holds the role of PRO Process expert within the PRO team at Janssen. In this role Trish represents the PRO functional... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC24: #24: Data Visualization in the Life Sciences
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response. For example, we may have a clear understanding for how a novel therapy induces an efficacious response, but there is typically limited knowledge into the downstream effects of the drug to other body systems. A second challenge to communication lies in the increased use of sensitivity analyses to assess the consistency and robustness of study results to varying assumptions. Given the volume of data to review and the variety of analyses to perform, it should come as no surprise that clear insight is often out of reach. In this environment, the traditional means of data summary – tables and listings – are ineffective for gaining insight; visualization is the key to effective communication for the modern clinical trialist. 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. At least 2/3 of the course will focus on case studies specific to clinical trials, while the remainder will be spent on examples in genomics. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the transition from traditional methods of data analysis to visual approaches;
  • Interpret life science data using one or more data visualizations;
  • Assess the strengths and limitations of various graphical techniques;
  • Explain the “data story” of numerous clinical research examples using data visualization techniques.



Speakers
avatar for Kelci Miclaus

Kelci Miclaus

Sr Manager, Advanced Analytics R&D, SAS Institute Inc., JMP Division
Dr. Kelci Miclaus is Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute where she manages the R&D team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics from North Carolina... Read More →
avatar for Richard C. Zink

Richard C. Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc
Richard C. Zink is Senior Director of Data Management and Statistics at TARGET PharmaSolutions. He is the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, host of the Biopharmaceutical Section Statistics Podcast, and Associate Editor for the DIA... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:00am

SC22: #22: Protocol Co-Design with Patients and Advocates
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

This short course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates. Following a brief introduction outlining the benefits of interactive activities with multiple stakeholders, you will engage in several activities:
  • Protocol red lining (individual/partner activity)
  • Design your own protocol (small group activity)
  • Walk the protocol (large group activity)
The first activity asks you to react to a draft protocol individually. You will then share your reactions with a partner representing a different stakeholder group. The second activity encourages collaboration among multiple stakeholders as table teams work to design a protocol that meets the needs of all stakeholders. The third and final activity will have the entire group reacting individually to a sample protocol (represented by posters on the wall), then discuss their reactions and seek consensus. Each activity will be debriefed to not only assess the experience, but to discuss how a similar activity might be applied to your needs. We will conclude by presenting a case-study that outlines the successful application of these methods for trial design. These exercises were designed by clinicians, instructional designers, and experts in patient literacy. They have been used successfully in numerous workshop settings to obtain input on protocol design features and trial recruitment and retention methods. Feedback on the experience from past participants has been very positive. It is our hope that you will leave the workshop with an understanding of how these types of exercises can be designed and executed to encourage collaboration and to design clinical trials that meet the needs of all stakeholders. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals responsible for clinical trial design and protocol development; clinical trials operations professionals; advocacy leaders who wish to collaborate with trial sponsors; CRO professionals; patient engagement professionals; advocacy engagement professionals.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate valuable and detailed input from patients and advocates on clinical trial design;
  • Design patient interactions that encourage collaboration among patients, sponsors, and advocacy groups;
  • Critique clinical trials to ensure they meet the needs of all stakeholders.



Speakers
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Maggie Adamski

Maggie Adamski

Senior Director, Global Patient Insights, ICON plc.
Maggie brings over 25 years of marketing and clinical research experience within pharma, CROs and agencies. Her work spans patient recruitment, advocacy engagement, patient insights, site training and patient engagement technology. Currently, as Senior Director, Global Patient Insights... Read More →
avatar for Ariel Rosen

Ariel Rosen

Director, Global Patient Insights, ICON plc.
Ariel has over 15 years of wide-ranging experience in clinical research including tenures as a study coordinator at large academic medical centers. She has an MS in Clinical Neuropsychology and spent a large portion of her career focusing on CNS indications. Ariel has extensive experience... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. Through hands-on experience with hypothetical case studies developed for this course, you will design a proactive approach for the identification and management of quality risks and issues; develop thresholds for triage thereby setting tolerance limits; and experience design trending leading to analytics to identify future signals and risks. You will leave with knowledge and access to materials that will enable you to design a framework for identification and mitigation of quality risks as well as management of issues with tolerance limits which could reside in your own organization’s risk management program.
The instructors will take you through the development of a cross functional quality strategy frame work 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. 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.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the risk process;
  • Design a comprehensive quality strategy to manage risk throughout the drug lifecycle and establish Quality Tolerance Limits and Issue Management;
  • Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.



Speakers
avatar for Victoria Burk

Victoria Burk

Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the R&D Quality Assurance director of Combination Products and Medical Devices at AbbVie. She leads a team responsible for Design Quality Assurance and the R&D Combination Product and Device Quality System. Vicki is also the business process owner for the R&D Comprehensive... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie, Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has... Read More →
avatar for Tim Grey

Tim Grey

Director,R&D Quality Systems, AbbVie, Inc.
Tim Grey joined AbbVie in December 2013. He is currently Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC21: #21: Basics of European Medical Device Regulation
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

This short course will cover what a medical device is (and what it is not) and discuss the legislation surrounding the European medical device regulation and why in Europe there is no combination product legislation. Participants will have the opportunity to classify medical devices which is the first step in the conformity assessment pathway leading to the affixing of a CE Mark to a product. This pathway includes a risk assessment, the basics of which will be explained. Mitigation of risk can be achieved in a variety of ways and the course will address some of them, particularly clinical investigations and labelling. The objective of this short course is to provide a basic understanding of European medical device regulatory requirements and how to ensure compliance with those regulations. Throughout the course there will be short exercises to confirm understanding and opportunities to apply knowledge gained. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals with no experience of European medical device legislation who require an introduction to the topic and staff working in the pharmaceutical sector who require a basic understanding of medical devices legislation in Europe.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Define what a medical device is, and is not;
  • Describe the key elements of the European Medical Device Regulation (MDR);
  • Classify a medical device;
  • Recognize the different steps relating to conformity assessment, risk and data required to gain a CE Mark;
  • Interpret the legislation to conduct a clinical investigation and manage a clinical evaluation report.



Speakers
NA

Neil Armstrong

CEO, MeddiQuest Reg Affairs Ltd
avatar for Angela Stokes

Angela Stokes

Vice President, Head Global Regulatory Consulting, Syneos Health
Angela has almost 30 years of experience in medicinal product and medical device development. Her strengths include regulatory and strategic advice, authorship of regulatory submissions, regulatory writing, regulatory research, and compliance with relevant guidelines and standards... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC23: #23: Preparing for a US FDA Advisory Committee Meeting
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. What You Will Learn:
  • What an advisory committee is
  • How an advisory committee is structured
  • Critical factors for advisory committee preparation
  • How to design the most applicable preparation program for your team
  • Top ten "best practices" and "must avoids"
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify the critical success factors in preparing for an advisory committee meeting;
  • Outline those factors that are most applicable to your team;
  • Design the most effective preparation strategy for your team(s).



Speakers
avatar for Kaia Agarwal

Kaia Agarwal

Strategic Lead, PharmApprove, LLC, a member of the NDA Group
Kaia Agarwal is an independent strategic regulatory affairs consultant working with PharmApprove. She helps teams prepare and implement global regulatory strategy for their products as they prepare for critical interactions with regulators, including EMA and FDA. For over 30 years... Read More →
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa helps development teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC40: #40: Interdisciplinary Safety Evaluation During Product Development
Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-19-517-L04-P; CME 6.50; IACET 6.50; RN 6.50

CIOMS VI (2005) states that “causality judgments based on analysis of multiple cases/aggregate data are almost always more meaningful and typically have a greater impact” (than the traditional case-based medical review). The FDA IND safety reporting final rule reflects that position by requiring an expedited IND safety report whenever aggregate analysis indicates that events occur more frequently in the drug treatment group than in a concurrent or historic control group. Further guidance has outlined how early planning for assessment of emerging safety signals and review of aggregated safety data throughout the development program should be driven by multi-disciplinary safety management teams (SMTs). Following product launch, connection of pre-launch investigations to data sources and analytics post-market enable ongoing surveillance, signal detection, and evaluation of benefit-risk. 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. Focus will target the application of appropriate statistical techniques with a safety mindset, as opposed to strict statistical inference, with the emphasis shifted from testing and confirming to exploration, learning, and medical decision-making within a quantitative framework. The goal is to empower the broader cross-disciplinary, cross-regional community to discover and promote practical quantitative solutions for safety evaluation during throughout the product life-cycle. Audience participation will be highly encouraged. This short course will present the work that has been done by the DIA-ASA Interdisciplinary Safety Evaluation scientific working group, TransCelerate, and ICH. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals from industry and regulatory agencies who practice in the areas of patient safety and pharmacovigilance. Specifically, individuals who routinely evaluate information and perform tasks such as signal detection, signal evaluation, benefit-risk assessment to determine the safety of products in development and on-market are the target for this proposed short course.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Examine the global regulatory landscape for interdisciplinary safety evaluation;
  • Develop an aggregate safety assessment planning (ASAP) process;
  • Execute ongoing aggregate safety evaluation (OASE), including: Blinded vs. unblinded analyses, static vs. dynamic assessments, and visual analytic methods, integration of data sources and analysis methods.



Speakers
avatar for Greg Ball

Greg Ball

Senior Principal Biostatistician, Merck & Co., Inc.
Dr. Greg Ball’s current research on blinded safety monitoring procedures emerged from his early work at academic medical centers and CROs, developed into his college dissertation and continues to be developed in collaboration with statistical and clinical scientists from several... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Senior Director, Decision Sciences, AbbVie, Inc.
Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel approaches and methodologies to improve patient safety. Jeremy has over 20 years... Read More →
avatar for James Buchanan

James Buchanan

Drug Safety Consultant, Covilance LLC
Dr. Buchanan has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical... Read More →


Sunday June 23, 2019 9:00am - 5:00pm
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC42: #42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-519-L04-P; CME 6.50; IACET 6.50; RN 6.50

The need to understand patient preferences for health and healthcare has become well established and demand for stated preference studies has grown exponentially in recent years. 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. The short course will also provide an overview of good research practices and principles that are broadly applicable to all stated-preference methods and describe how good research practices can be applied to discrete choice experiments and several other stated-preference methods. Topics to be covered will include designing a survey, developing an experimental design, analyzing data, and presenting results. This short course will include hands-on exercises and detailed case studies of recent empirical examples to illustrate concepts. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This introductory to mid-level course designed to acquaint attendees with the current state of the art in the use of methods for the development of evidentiary patient preference information. Expected attendees may include: industry, regulators, payers, patients and patient advocacy representatives.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify when & how to successfully develop and present patient preference information for use in a range of applications, including regulatory interactions such as new drug applications;
  • Discuss specific methodologies frequently used in the development of patient preference information.



Speakers
avatar for Rachael DiSantostefano

Rachael DiSantostefano

Senior Director, Benefit Risk, Epidemiology, Janssen Research & Development, LLC
Rachael L. DiSantostefano, MS PhD, is a Senior Director of Benefit-Risk in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes... Read More →
avatar for Brett Hauber

Brett Hauber

Senior Economist, Vice President of Health Preference Assessment, RTI Health Solutions
Brett Hauber is Senior Economist and Vice President of Health Preference Assessment at RTI Health Solutions and Affiliate Associate Professor in the School of Pharmacy at the University of Washington. His is an expert in stated-preference methods. He was principal investigator for... Read More →
avatar for Carol Mansfield

Carol Mansfield

Senior Economist and Head, Health Preference Assessment, RTI Health Solutions
Carol Mansfield, PhD, is a Senior Economist and Head in the Health Preference Assessment group at RTI-HS, where she conducts stated-preference studies for pharmaceutical applications. She has 25 years of experience conducting research related to health and the environment. She has... Read More →
CP

Christine Poulos

Senior Research Economist and Head, Health Preference Assessment, RTI Health Solutions
avatar for Kristin Bullok

Kristin Bullok

Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company
Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →


Sunday June 23, 2019 9:00am - 5:00pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC43: #43: Back to the Future: Combination Products in the 21st Century
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-520-L04-P; CME 6.50; IACET 6.50; RN 6.50

As innovation abounds in science and medicine, there exist endless new opportunities for combining different technologies to solve some of the world’s most pressing medical issues. The lines between engineering, chemistry, and advanced biologic processes are becoming blurred – the age of combination products is here. There are significant differences between the development processes for drugs, devices, and biologics. Theoretically, if the product complies with the regulations specific for each component of the combination product, then your company should be covered, right? Not quite! The requirements and governing bodies for each part of the product are vastly different making it nearly impossible to reconcile all the rules. Factor in new laws and regulations, such as the 21st Century Cures Act (CCA), and the complexity of compliance increases further. This short course provides an overview and comparison of drug, device, and biologics regulation in the United States, and the complex place where combination products fit within these regulations. It follows the product lifecycle, from development through post-market activities, including classification, pre-clinical and clinical requirements, applicability of Good Manufacturing Practices (GMPs) and quality systems, and labeling requirements. It will also introduce the latest statutes, regulations and guidances that impact combination products and discuss how these changes are affecting the existing market. The short course will be interactive. It has been designed to integrate substantive regulatory knowledge and the real-world problems of combination products. You will dive into case studies of unique combination products and get a sense of the gray areas that make the current regulatory scheme so difficult to navigate. It’s an opportunity to ask questions, share your challenges, gain the insights of your instructors, and learn from the experiences of your colleagues. If you are new to the field of combination products, this course will give you the foundation to move forward in your career. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for regulatory, quality, and clinical professionals and project managers who are new to combination products.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Discuss how combination products fit into the development processes for drugs/biologics and medical devices;
  • Identify the unique challenges of pre-market and post-market requirements for combination products in the US;
  • Discuss how recent regulatory developments, including the 21st Century Cures Act enacted in 2016 and resulting FDA guidances, affect combination products.



Speakers
CB

Caitlin Bancroft

Associate, Regulatory Affairs Consultant, Pharmatech Associates Inc.
avatar for Lynn Hansen

Lynn Hansen

Director, Regulatory Affairs, Pharmatech Associates Inc.


Sunday June 23, 2019 9:00am - 5:00pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC41: #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-518-L04-P; CME 6.50; IACET 6.50; RN 6.50

According to the 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. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals and auditors involved in Good Clinical, Laboratory, or Manufacturing Practices.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe and train individuals on best industry practices in CAPA management;
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and Effectiveness Checks to ensure compliance and remediation of observations;
  • Discuss case studies that will help solidify how to use the different tools and why to use each one.



Speakers
avatar for Christy Mazzarisi

Christy Mazzarisi

Associate Director, Development Operations, Q&C/CTD, Kinapse
Accomplished Quality Systems Professional with a broad background in Pharmaceutical and Laboratory sciences with R&D and commercial manufacturing (sterile and non-sterile) experience with 15 years industry practice. Overall background and specialties include GMP and GLP; which has... Read More →
avatar for Danielle Metzger

Danielle Metzger

Manager, Development Operations, Q&C, Kinapse
Accomplished Quality Professional with a broad background in Pharmaceutical life sciences having R&D and commercial (sterile/non-sterile) experience with over 20 years practice. Specialize in Deviation/CAPA Management and TrackWise systems. Well versed in cGMP knowledge, FDA/EU regulations... Read More →


Sunday June 23, 2019 9:00am - 5:00pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:30pm

SC30: #30: Machine Learning in Pharmacovigilance
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

Since machine learning (ML) requires resources from across the organization, this course is designed for anyone interested in sponsoring or joining a ML project within their organization which focuses on pharmacovigilance (PV). Therefore, we 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, including examples from our own experiences with ICSR identification, and discussion around what the future of ML in PV could look like. There will be time for Q&A but this years course will also be very interactive between the instructors and attendees, with both questions and some relevant tool demonstrations. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for members of Pharma, Academia, Regulators, and Medicine interested in Machine Learning in PV.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify advances that make ML practical;
  • Describe how ML can be applied to the regulatory and PV landscape;
  • Develop potential future use cases for ML in PV.



Speakers
avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →
avatar for Shaun Comfort

Shaun Comfort

Principal Medical Director, Genentech, A Member of the Roche Group
Dr. Comfort is Principal Medical Director for Roche in the Inflammatory, Infectious Disease, and Ophthalmology Safety Science group and leads innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 16 years combined industry/regulatory experience including... Read More →
avatar for Bruce Donzanti

Bruce Donzanti

Senior Group Director, Global Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while... Read More →
avatar for Mick Foy

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:30pm

SC36: #36: A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-515-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. Each will be made available as an open-source, non-proprietary application widely available to anyone interested in drug safety evaluation. An open source project like this will likely result in a longer-lasting software solution. The first tool to be released is designed to explore cases of potential drug-induced hepatotoxicity based on the eDISH plot developed by FDA. Building upon the existing static eDISH plot, the tool allows the user to dynamically adjust laboratory thresholds to account for disease states with elevated transaminase and bilirubin values, modify the time dimension for the occurrence of peak ALT/AST and bilirubin values, account for the extent of alkaline phosphatase elevation, with filters for treatment assignment, gender, race and age group. Cases that appear in the potential Hy’s Law, Temple’s corollary and hyperbilirubinemia quadrants can be individually explored to detail the time course of changes in various analytes, and assess the concurrence with adverse events and the exposure to concomitant medications. In order to assist the safety reviewer, a workflow is provided to guide the user through the recommended analyses, using the features of the tool, for each of the quadrants of interest. The workflow is based on evaluations supported by expert hepatologists and the medical literature. The short course will demonstrate the functions of the tool by way of case examples exploring various hepatotoxicity signals. Prior attendees of the DIA Advanced Signal Detection course will find this course builds upon the concepts presented in that course, but it is not a prerequisite for attending this class. In addition, information will be provided on how attendees can implement this RShiny/JavaScript tool in their organizations. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved in:
  • Clinical safety and pharmacovigilance
  • Pharmacoepidemiology
  • Biostatistics
  • Benefit-risk management
  • Clinical development
  • Data scientists
  • Information technology supporting pharmacovigilance activities


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate the potential for drug-induced hepatotoxicity with a new open-source, interactive safety graphic based on the eDISH plot;
  • Assess cases of potential Hy’s Law, Temple’s corollary and hyperbilirubinemia with respect to lab changes, clinical symptoms and identify possible confounding elements;
  • Perform analyses with a work-flow procedure based on established medical precedent.



Speakers
avatar for James Buchanan

James Buchanan

Drug Safety Consultant, Covilance LLC
Dr. Buchanan has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical... Read More →
avatar for Jeremy Wildfire

Jeremy Wildfire

Senior Data Scientist, Rho, Inc.
I have worked as a biostatistician for the NIAID funded Inner City Asthma Consortium (ICAC) for nearly 10 years. My work with ICAC has included the development of the Composite Asthma Severity Index, the first quantitative measure of asthma severity, and the analysis of multiple late-stage... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:30pm

SC37: #37: Patient Literacy 101: Practical Strategies for Improving Your Patient Materials
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-516-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. Patient literacy (or health literacy) is certainly not a new topic, yet isn’t getting its much-deserved attention these days. Materials developed for patient communications or education often miss the mark. The application of literacy and numeracy principles is now more critical than ever, due to the increased tendency of patients to seek out disease state and treatment-related information on their own. In this interactive short course, participants will learn principles of patient literacy, receive a number of tools to assist them in developing their own patient-literate materials, and learn about excellent resources that can be used to help them continue to develop their skills in this area. Interactive exercises will provide opportunities to practice these skills. This will include evaluating existing materials, editing to improve literacy, and development of new materials. We will address both written and oral communication. Finally, an active discussion will provide strategies on how participants can work to encourage a culture of patient literacy within their own organizations, becoming champions of this approach and bringing about true cultural change. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for individuals responsible for the design and development of patient-facing materials; clinical educators; developers of patient educational materials.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Define patient literacy, numeracy and health literacy, describe how each affects the quality of patient communications and educational efforts;
  • Identify common mistakes in patient-facing materials;
  • Develop a strategy for improving your organization’s patient-facing communications;
  • Develop a culture that embraces patient literacy principles.



Speakers
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Valerie Martin

Valerie Martin

Associate, Global Patient Insights and Engagement, ICON plc.
Valerie’s career has been centered around leading and managing large-scale, global patient recruitment and retention programs. She also has extensive experience crafting individualized site support initiatives to accelerate enrollment. She prioritizes the needs of each program’s... Read More →
avatar for Ariel Rosen

Ariel Rosen

Director, Global Patient Insights, ICON plc.
Ariel has over 15 years of wide-ranging experience in clinical research including tenures as a study coordinator at large academic medical centers. She has an MS in Clinical Neuropsychology and spent a large portion of her career focusing on CNS indications. Ariel has extensive experience... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:30pm

SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
  • Discuss the use of key tools in the RBM process;
  • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.



Speakers
avatar for Barbara Suarez

Barbara Suarez

Director, Clinical Study Support, GlaxoSmithKline
Barbara A. Suarez, M.S., Director of Clinical Study Support for the US Local Operating Company at GlaxoSmithKline Pharmaceuticals. Over the course of 20 years within the industry, Barbara has served in diverse roles of increased responsibilities within Clinical Operations. Since 2013... Read More →
avatar for Rodrigo Perez

Rodrigo Perez

CSU Risk-Based Monitoring (RBM) Business Lead, Sanofi
Rodrigo Perez, based in Mexico City, has more than 12 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:30pm

SC33: #33: European Regulatory Meetings: How Best to Prepare and Perform
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

High-stakes meetings such as CHMP/PRAC oral explanations are often the ultimate chance for a pharmaceutical sponsor to convince EU regulators that the benefit:risk balance of their product is positive. Being well-prepared and performing professional is key to success. This include demonstrating intimate knowledge of your data to meet regulator’s concern as well as being able to present this in a crisp and clear manner. To get to this stage takes meticulous preparation of key messages, slides and the actual speech and may additionally include training key opinion leaders and/or patient representatives to speak or respond to questions in your support. Finally, preparing a head of questions and being able to respond clear and unequivocally to these are equally important to increase chances of success. 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. Focus will be on CHMP oral explanations, but the learnings will be applicable to all other EU regulatory oral interactions. We will discuss how best to present your key massages and supporting slides and manuscript. How to develop a Q&A grid in collaboration with your team and how best to manage back-up slides when responding to questions will be part of the learnings. How best to deal with practicalities and logistics around a CHMP oral explanation in order to minimize the stress on your team will also be touch upon. 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. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals in Regulatory and Clinical teams.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify the key messages and supporting slides needed to conduct a successful EU regulators meeting;
  • Develop a comprehensive Q&A grid;
  • Develop a strategy and encourage the development of back – up slides when preparing questions.



Speakers
avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa helps development teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:30pm

SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-514-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Explain the major elements of the Japanese regulatory system;
  • Describe the regulatory procedures during development, registration, and post-approval;
  • Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.



Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial