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DIA 2016 Annual Meeting

Add Sunday Tutorials. Eighteen options to choose from! Space is limited. Pre-registration required.
DIAmond Sessions—NEW!
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CISCRP Medical Heroes Appreciation 5K. Starts Monday, bright and early!
Sunday Networking Session. Limited seating available. RSVP requested.
View Professional and Student Poster details
View Final Program

9:00am EDT

Exhibitor Registration Open TBA

8:00am EDT

Registration for Full Day and Morning Preconference Tutorials Open TBA Exhibitor Registration Open TBA

8:30am EDT

#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing 102AB #24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China 104AB #20: The Sunshine Act: Understanding the Essentials of Compliance 107AB #23: How to Prepare for an FDA Inspection 103A #25: Signal Detection: Identifying and Managing Safety Signals 105AB #21: Leadership: How to Organize and Lead People in a Work Group 103C #26: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment 108A

9:00am EDT

#43: Risk Management and Safety Communication Strategies 113B #44: The Good Pharmacovigilance Practices in the EU: Global Applications 113C #40: Analysis of Safety Data from Clinical Trials 111AB #42: Clinical Statistics for Nonstatisticians 113A #41: A Rare Disease Program Case Study: Strategies for Successful Outcomes 112AB

11:45am EDT

Annual Meeting of Members Liberty Ballroom A

12:30pm EDT

Registration for Afternoon Preconference Tutorials, Conference Attendees, and Speakers TBA

1:00pm EDT

#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development 102AB #31: Preparing for a US FDA Advisory Committee Meeting 103A #34: Ethical Issues in Clinical Trials 104AB #33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports 107AB #32: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation 105AB #37: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model 108A

2:45pm EDT

#001: Powerful Presentations 202AB

4:15pm EDT

#002: Networking: It's Personal - Understanding Yourself and Others to Maximize Personal Interaction 202AB

6:30am EDT

CISCRP Medical Heroes Appreciation 5K TBD

7:00am EDT

Coffee and Light Refreshments TBA Attendee, Speaker, and Exhibitor Registration Open TBA

7:30am EDT

Annual Meeting Orientation and Networking 104A

8:30am EDT

#106: Fostering a Partnership to Advance Innovation: Niche Service Leads to Breakthrough in Patient Recruitment and Retention Challenges 112AB #117: IDMP: A Compliance Project or a New Way of Conducting Business? 109AB #101: Opportunities for Improving Informed Consent of Clinical Research Volunteers 113C #102: Digital Health Debate 113A #103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science 113B #104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy 105AB #105: Maximize the Value of Your Product by Beginning with the End in Mind 107AB #107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost 202AB #113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements 108B #108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness? 203AB #109: EHR in Clinical Research: Heralding a New Era 201C #110: Updates and Pending Issues in the US Biosimilar Environment 201B #111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring? 204B #112: The Upcoming European Clinical Trials Regulation 204C #114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward 204A #115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product 111AB #116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment? 103C #118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data 201A #119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials 102AB #120: DIA 2016: Student Forum 108A #121: Rare Disease Clinical Trials: Coping with Unique Challenges 103A

9:30am EDT

Coffee Break Exhibit Hall Exhibit Hall Open TBA Student Poster Session TBD

10:00am EDT

Speaker Training Session 104A #122: DBMS Consulting/Clinical Ink Innovation Theater: Accelerating Clinical Trial Innovation: Technology Case Studies for Improving Data Collection, Monitoring, and Medical Coding Processes Exhibit Hall B

10:45am EDT

#142: Why We All Need Mentors (and How to Be a Good Mentor to Others) 107AB #144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial Exhibit Hall A #123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America 113B #124: Risk-Based Monitoring in Clinical Trials 113C #125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration 113A #126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development 102AB #127: Innovative Partnerships: gOVERN - A Research and Early Development’s Outsourcing Vision to Enable Resourcing INovation 112AB #128: Alliance Management Forum 111AB #129: Delivering Value Through Medical Information Metrics 203AB #130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial 201C #132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned 204C #131: IDMP Update 204B #133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME! 201B #135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers 108B #134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy? 103A #136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates 202AB #137: Using Technology to Make Trials Accessible to More Clinical Trial Participants 204A #138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices 109AB #139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations? 105AB #140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements 108A #141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model 201A #143: Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors 103C

11:45am EDT

Luncheon Exhibit Hall

12:15pm EDT

#146: Tata Consultancy Services Innovation Theater: Data Transparency Initiative: An Innovative Solution Exhibit Hall B #147: Interpreting Meaningful Change on PRO Instruments: Methods in Action Exhibit Hall A #145: Student Poster Session and Oral Presentations 1A Exhibit Hall A

1:00pm EDT

#148: PAREXEL Innovation Theater: Balancing Rapid Approval with Demonstration of Value Exhibit Hall B

1:30pm EDT

#149: EMA's Publication Policy 0070: Best Practices for Implementation Exhibit Hall A

1:45pm EDT

#150: Quintiles Innovation Theater: Evidence Optimization: Fueling Smarter Clinical Development and Value Generation Exhibit Hall B

2:30pm EDT

#151: Plenary Session and Keynote Address Ballroom AB

4:00pm EDT

Opening Reception Exhibit Hall

4:15pm EDT

#152: Student Poster Session and Oral Presentations 1B Exhibit Hall A

4:30pm EDT

#153: BBK Innovation Theater: Reimagining the Patient Experience Through mHealth Technologies Exhibit Hall B

5:15pm EDT

#154: ConvergeHealth by Deloitte Innovation Theater Exhibit Hall B

5:30pm EDT

Student Poster Awards Ceremony Exhibit Hall

7:00am EDT

Coffee and Light Refreshments TBA Attendee, Speaker, and Exhibitor Registration Open TBA

8:00am EDT

#202: Changing Cultures to Advance Patient Engagement 103ABC #203: Next Generation Collaborations: Transforming the Industry Ballroom A #201: International Regulatory Convergence, Collaboration, and Cooperation 114

9:00am EDT

Exhibit Hall Open TBA Professional Poster Session 1 TBD

9:30am EDT

Coffee Break Exhibit Hall

9:40am EDT

#204: Professional Poster Session and Oral Presentions 1A Exhibit Hall A #205: It’s Not You; It’s Me: Dealing with Team Challenges, Critique, and Criticism Exhibit Hall A

9:45am EDT

Speaker Training Session 104A #206: Covance Innovation Theater: Leveraging Patient Data and Historical Investigator Performance Data to Realize Faster Patient Recruitment Exhibit Hall B

10:30am EDT

#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative 108A #213: FDA Enforcement Update: Advertising and Promotion 107AB #215: Exploring the Use of Virtual Technologies and Virtual Teams Within Medical Affairs Organizations 202AB #218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification 201B #220: Regulatory Changes in China and the Impact to Global Drug Development Planning 109AB #222: Valuing the Clinical Trial Patient 204A #224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How 201A #227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development 103C #208: Measuring Return on Engagement: An Interim Report on the DIA-Tufts CSDD Metrics Study 108B #209: The Promotable Project Manager: Leadership Behaviors Critical to Success in the Life Sciences 102AB #210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management 105AB #211: Collaboration with a Purpose 111AB #212: Special Populations in Clinical Pharmacology Studies 113A #214: Product Management Strategies: Maximizing Content Re-Use to Meet Diverse Customer Information Needs 203AB #217: Electronic Submissions Gateway: Next Generation 201C #216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step 204C #219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development 204B #221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment 103A #223: Global Harmonization: Current ICH Quality Initiatives 112AB #226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities 113C #225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems 113B

10:45am EDT

#228: Increase Value of Clinical Trials Through Impactful Branding Exhibit Hall A

11:30am EDT

Luncheon Exhibit Hall

12:00pm EDT

#230: Quintiles Innovation Theater: Transforming Patient Recruitment Through Site and Patient Engagement Exhibit Hall B #231: Introduction to Structured Content Exhibit Hall A Innovation Row Tour 107AB #229: Professional Poster Session and Oral Presentions 1B Exhibit Hall A

12:40pm EDT

#232: PRA Innovation Theater: Transforming EMR to EDC Exhibit Hall B

1:20pm EDT

#233: Veeva Innovation Theater: The Great RIM Throwdown! How Are You Managing Regulatory Events? Exhibit Hall B

1:30pm EDT

Exhibit Guest Passes TBA

2:00pm EDT

#235: Global Clinical Supply Logistics Study 113A #237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge 112AB #252: Capturing Real-World Data in Rare Diseases 103C #253: Update from Health Canada 202AB #255A: DIA Innovation Theater: Special Session for Exhibitors: Global Trends in Drug Development and Opportunities with DIA Worldwide Exhibit Hall B #255B: Lost in Translation: The Importance of Data Presentation Exhibit Hall A #234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning 109AB #236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations 108B #238: Prescription Drug Marketing Regulatory Primer 107AB #240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards 204B #239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views 201C #241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease 201B #242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology 108A #243: Patient Involvement Today and Tomorrow: What’s in It for Patients? 204C #244: Transforming Clinical Development Through Enterprise Quality Management 204A #245: Risk-Based Inspections 111AB #246: Valuing the Signal and the Noise in Health Care Horizon Scanning 103A #247: Fit for Purpose and Modern Validity Theory in PROs 105AB #248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products 113C #249: Current Topics for Pharmacovigilance in Japan 113B #250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics 201A #251: Embracing Virtual Training Solutions in 2016: Focus on Performance! 102AB #254: CBER Town Hall: State of the Center and Plans for the Future 203AB

3:00pm EDT

Refreshment Break TBA

3:25pm EDT

#256: Veeva Innovation Theater: 2016 Paperless TMF Survey: Trends and Insights Exhibit Hall B

4:00pm EDT

#262: Solving Challenges and Employing Best Practices in Medical Information Contact Centers 201A #269: Making Quality Stick: Building a Complete Quality Culture 204A #278: Real Life Application of Risk-Based Monitoring Exhibit Hall A #257: Mobile Apps for Clinical Trials: DIY or AMAZON Strategy? When to Build, When to Buy 113A #259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies 112AB #260: A Risk-Benefit Approach to Planning Early Clinical Development 113C #261: Marketing After Amarin and Pacira 107AB #263: Patient Centricity in Clinical Trials 201B #264: FDA Update on Data Standards 204B #265: Enabling Innovative New Endpoint Measurement Using Mobile Technology 203AB #266: Perspectives on Expanded Access to Investigational New Drugs 108A #267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development? 105AB #268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications 201C #270: Implementing Knowledge Management: Industry Perspectives 111AB #271: The Things Kids Say: Clinical Outcome Assessments in Pediatric Clinical Trials 103A #272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance? 113B #273: Improving Adverse Drug Reaction Information in Product Labels 109AB #274: Statistical Issues in the Evaluation of Biosimilars 108B #275: Creating a Competency-Based Onboarding and Learning Program on a Budget 102AB #276: Using Input from Patient Communities to Develop PRO Instruments 103C #277: PMDA Town Hall 202AB

7:00am EDT

Coffee and Light Refreshments TBA Attendee, Speaker, and Exhibitor Registration Open TBA

8:00am EDT

#301: The Future of Big Data 103ABC #302: Europe and the US: Making Outcomes-Based Health Care Possible 114 #303: Value-Based Health Care Decision Making: The Quest for Smarter Spending Ballroom A

9:00am EDT

Exhibit Hall Open TBA Professional Poster Session 2. TBD

9:30am EDT

Coffee Break Exhibit Hall

9:40am EDT

#304: Professional Poster Session and Oral Presentions 2A Exhibit Hall A #305: MedDRA: Use in the Review of New Drug Applications at the FDA Exhibit Hall A

9:45am EDT

Speaker Training Session 104A #306: SAS/JMP Innovation Theater: Efficient Safety Assessment in Clinical Trials Using the Computer-Generated Adverse Event Narratives of JMP Clinical Exhibit Hall B

10:30am EDT

#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials 201A #312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies 113C #314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End 203AB #318: Changes to Common Rule Likely Affecting FDA-Governed Research 202AB #322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence 107AB #327: FDA–Health Canada Regulatory Cooperation Council Town Hall 201C #307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options 108A #308: Patient Recruitment Workshop: Survey Results and Practical Application 102AB #310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch 108B #309: Global Stakeholder Management: Across the Ocean Between East and West 105AB #311: Outsourcing: Assessing CRO Performance and Challenges 111AB #313: The Future of Clinical Research Data: 2020 and Beyond 204B #315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My! 201B #316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation 204C #317: Global Medical Device Development: Regulatory Concordance or Discordance? 103C #319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development 204A #321: Office of Pharmaceutical Quality Update 113B #323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation 113A #324: Implementing Adaptive Designs Involves Greater Teamwork 109AB #325: Reinventing You: How to Change Your Career Fearlessly! 112AB #326: FDA Rare Disease Town Hall 103A

10:45am EDT

#328: The Ethics of “Big Data” Biomedical Science Exhibit Hall A

11:30am EDT

Luncheon Exhibit Hall

12:00pm EDT

#330: SAS Innovation Theater: Empowering Action – Fueling Safety and Operational Efficiency Exhibit Hall B #331: Applying Design Thinking to Clinical Development: Human-Centered Approaches to Improve Quality and Efficiency Exhibit Hall A #329: Professional Poster Session and Oral Presentions 2B Exhibit Hall A

12:40pm EDT

#332A: Salesforce Innovation Theater: Connect to Your Patients, Providers, and Partners in a Whole New Way with the Salesforce Platform Exhibit Hall B

1:20pm EDT

#332B: SAP Innovation Theater: Too Much R&D Data to Develop New Drugs and Medical Devices? Exhibit Hall B

1:30pm EDT

Exhibit Guest Passes TBA

2:00pm EDT

#341: eTMF: Selection, Implementation, and What's Next? 204B #351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies 108B #353: The Utility of Natural History Studies in Drug Development and Approval 103C #354: Protocol Optimization: Making It Real Exhibit Hall A #333: Hearing the Patient Voice in Pharma and What Patients Want You to Know 113A #334: Risky Business: Latest Trends, Strategies, and Tools for Predicting Success and Monitoring Risk During Clinical Trial Operations 113B #335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials 113C #336: Effect of International Reference Pricing on Planning for Global New Product Launches 105AB #337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools 112AB #338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection 201A #339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them 203AB #342: Big Data in Health Care and Life Sciences 201C #340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research 204C #343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape 201B #344: Companion Diagnostics: Driving New Business Models for Successful Outcomes 103A #345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority? 202AB #346: Anticipating and Responding to Challenges in Issue Management 204A #347: Global Harmonization: Non-ICH Regions 111AB #348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC 107AB #349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements 109AB #352: From Mistakes to Success: Lessons Learned from Organizational Change Management Programs 102AB #350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort? 108A

3:00pm EDT

Refreshment Break TBA

3:15pm EDT

#356: Let's Enjoy Global Stakeholder Management Exhibit Hall A

3:25pm EDT

#355: DBMS Consulting/Clinical Ink Innovation Theater: Safety Data Delay Is a Risk-Enhanced Signal Detection with Customized MedDRA and Drug Grouping Queries Exhibit Hall B

4:00pm EDT

#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results 105AB #361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep 203AB #367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies 204A #368: Conducting Trials in China 201A #372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes 113C #371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety 113A #374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations 108A #375: Creating Competent Clinical Research Professionals Through Systematic Evidence Review 112AB #357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects 108B #358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages 102AB #359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk 111AB #362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders 204C #363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines 201B #364: Cell and Gene Therapies: Current Global Landscape 204B #365: Cross-Labeling of Drugs and Devices: How Can It Be Done? 103A #366: Infectious Disease Containment and Lessons Learned 202AB #369: Innovative and Emerging Technologies 109AB #370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices 107AB #373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs 113B #376: Pediatric Rare Disease Drug Development 103C

8:00am EDT

Coffee and Light Refreshments TBA Attendee and Speaker Registration TBA

9:00am EDT

#401: EMA/FDA Question Time 114 #402: Protocol Development Is a Team Sport 103ABC

10:30am EDT

Coffee Break TBA

10:45am EDT

#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress 111AB #408: Securing Internet-Driven Collaboration in Drug Development 109AB #403: Running Personalized Medicine Trials: Facts and Figures 108B #404: Bringing CRO Collaboration into the 21st Century 112AB #405: Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies 107AB #406: Navigating Partnerships and Submissions: Best Practices for Successful Medical Writing Deliverables Involving Multiple Stakeholders 113A #409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment 113C #410: The Role of Big Data in Transforming the Detection of Adverse Drug Reactions 113B #411: Nonclinical Statistics for Chemistry, Manufacturing, and Control: Case Studies and Regulatory Perspective 108A #412: CDER Town Hall 114