|
Mon, June 24
|
8:30AM
|
Opening Plenary
|
|
|
Ling Su
|
|
Mon, June 24
|
11:00AM
|
Shape Your Cost with Hard and Soft Coverage Analysis Trends
|
CME, IACET, PMI, RN
|
Clinical Operations
|
Kelly M. Willenberg
|
|
Mon, June 24
|
11:00AM
|
Finessing Scientifically Accurate, Comprehensible, Compliant, Clinically-focused Module 2 Summaries of an eCTD-based Submission
|
IACET
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Nancy R. Katz
|
|
Mon, June 24
|
11:00AM
|
Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Mark C. Hegarty
|
|
Mon, June 24
|
11:00AM
|
Trials, Studies and Programs: Diverse Operational Approaches to Generating Evidence in the Late-phase Environment
|
CME, IACET, RN
|
Clinical Operations
|
Gary Coward
|
|
Mon, June 24
|
11:00AM
|
Practical Considerations for GCP Audits in a Risk-based Environment
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Michael R. Hamrell
|
|
Mon, June 24
|
11:00AM
|
Vendor Management Using Quality by Design and Risk Management Strategies
|
IACET
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Sherri A. Hubby
|
|
Mon, June 24
|
11:00AM
|
Stage Gate Decision-making Workshop, Part 1 of 2
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Courtland R. LaVallee
|
|
Mon, June 24
|
11:00AM
|
Portfolio Management Symposium
|
IACET, PMI
|
Project/Portfolio Management and Strategic Planning
|
Gregg Schneider
|
|
Mon, June 24
|
11:00AM
|
The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Denise A Calaprice-Whitty
|
|
Mon, June 24
|
11:00AM
|
Innovative Partnerships for mHealth
|
CME, IACET, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Nancy Carter-Foster
|
|
Mon, June 24
|
11:00AM
|
Global Symposium
|
CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Barry Mangum
|
|
Mon, June 24
|
11:00AM
|
Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon
|
CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Janet Jenkins-Showalter
|
|
Mon, June 24
|
11:00AM
|
Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets
|
CME, IACET, RN
|
Pharmaceutical Quality
|
Thirunellai G Venkateshwaran
|
|
Mon, June 24
|
11:00AM
|
Hot Topics in Statistics: Working Together Effectively to Transform Our Science
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Stephen E. Wilson
|
|
Mon, June 24
|
11:00AM
|
Challenges and Solutions for Professional Development and Training of Clinical/Nonclinical Staff
|
CME, IACET, RN
|
Professional Development
|
Nancy P. Smerkanich
|
|
Mon, June 24
|
11:00AM
|
Evaluation and Selection of the Optimal Endpoints for Clinical Studies
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Freda W. Cooner
|
|
Mon, June 24
|
11:00AM
|
Managing Data at Arms' Length: China
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Ralph Douglas Harkins
|
|
Mon, June 24
|
11:00AM
|
CBER Town Hall
|
CME, IACET, RN
|
Global Regulatory
|
Karen Midthun
|
|
Mon, June 24
|
11:00AM
|
Electronic Health Records (EHRs) in Signal Detection and Evaluation
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Preciosa M. Coloma
|
|
Mon, June 24
|
11:00AM
|
Narrative Medicine and Pharmacovigilance
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Michael A. Ibara
|
|
Mon, June 24
|
11:00AM
|
Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Virginia L. Behr
|
|
Mon, June 24
|
11:00AM
|
Pediatric Drug Development: A New Paradigm Under FDASIA
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Rosemary M. Addy
|
|
Mon, June 24
|
11:00AM
|
European Town Hall: Implementation of New Safety Legislation and Other Hot Topics
|
CME, IACET, RN
|
Global Regulatory
|
Guido Rasi
|
|
Mon, June 24
|
11:00AM
|
How Can Translational Medicine Fill the Gaps in Life Sciences Industries?
|
CME, IACET, RN
|
Communities Showcase
|
Aamir Shahzad
|
|
Mon, June 24
|
11:00AM
|
Next Generation Medical Information Call Center
|
|
White Paper Showcase
|
Charles M. Kalfaian
|
|
Mon, June 24
|
1:00PM
|
IntraLinks Innovation Theater: Crossing the Threshold – Clinical Portals from a Site Perspective
|
|
Innovation Theater
|
Intralinks, Inc.
|
|
Mon, June 24
|
2:30PM
|
Implementing Performance Metrics: How Investigator Sites Can Pave the Way for Running Successful Clinical Trials
|
CME, IACET, RN
|
Clinical Operations
|
Christine K. Pierre
|
|
Mon, June 24
|
2:30PM
|
Cooperation Among Regulators: Impact on Stakeholders
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Marie Allison Dray,Murray M. Lumpkin
|
|
Mon, June 24
|
2:30PM
|
Legal Jeopardy from the Conduct of Clinical Trials
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Mark C. Hegarty
|
|
Mon, June 24
|
2:30PM
|
Global Clinical Trials: The Role of Emerging Markets
|
CME, IACET, RN
|
Clinical Operations
|
Nancy Meyerson-Hess
|
|
Mon, June 24
|
2:30PM
|
Effectiveness Checks in the Clinical Research Setting
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Cassandra Kennedy
|
|
Mon, June 24
|
2:30PM
|
Quality Risk Management: An Old Hat?
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Beat E. Widler
|
|
Mon, June 24
|
2:30PM
|
Stage Gate Decision-making Workshop, Part 2 of 2
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Courtland R. LaVallee
|
|
Mon, June 24
|
2:30PM
|
Bridging the Gap Between Strategy and Execution
|
CME, IACET, PMI, RN
|
Project/Portfolio Management and Strategic Planning
|
Akhil Agrawal
|
|
Mon, June 24
|
2:30PM
|
Implementing Regulatory Outsourcing Partnerships: New Trends and Practices
|
IACET
|
Innovative Partnering Models and Outsourcing Strategies
|
Tracy Tsuetaki
|
|
Mon, June 24
|
2:30PM
|
Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations
|
ACPE, CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Celine Adessi
|
|
Mon, June 24
|
2:30PM
|
Using Epidemiologic Methods to Advance Comparative Effectiveness Research
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Nancy A Dreyer
|
|
Mon, June 24
|
2:30PM
|
Update on Submission and GMP Expectations for Part 3 Combination Products
|
CME, IACET, RN
|
Pharmaceutical Quality
|
Michael Folkendt
|
|
Mon, June 24
|
2:30PM
|
Key Multiplicity Issues in Clinical Trials
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Alex Dmitrienko
|
|
Mon, June 24
|
2:30PM
|
The Secret of Stellar Careers: Serendipity plus Planning = Success
|
IACET
|
Professional Development
|
Sandra A Wiejowski
|
|
Mon, June 24
|
2:30PM
|
CDISC SHARE: A Promising Approach to Therapeutic Area Standards Development
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Julie Evans
|
|
Mon, June 24
|
2:30PM
|
That Awkward Stage: Transition from Paper Trial Master File to eTMF
|
IACET
|
Processes and Technologies for Clinical Research
|
Denise Derenzo Lacey
|
|
Mon, June 24
|
2:30PM
|
The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Sabine Brosch
|
|
Mon, June 24
|
2:30PM
|
Characterizing Drug Shortages and Their Causes: Anticipating Future Trends
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Kenneth A. Getz
|
|
Mon, June 24
|
2:30PM
|
Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Mark J. Hope
|
|
Mon, June 24
|
2:30PM
|
Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Jeffrey N. Stuart
|
|
Mon, June 24
|
2:30PM
|
Defining Clinical Trial Innovation: Challenges and Opportunities for 2013
|
CME, IACET, RN
|
Communities Showcase
|
Susan K. Nunchuck
|
|
Tue, June 25
|
8:00AM
|
Prescription Drug Marketing Regulatory Primer
|
ACPE, CME, IACET, RN
|
Regulation of Product Advertising and Marketing in an Ever-changing World
|
Janet L. "Lucy" Rose
|
|
Tue, June 25
|
8:00AM
|
The Regulatory Writing Game Show
|
IACET
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Jessie Wolfe Galson
|
|
Tue, June 25
|
8:00AM
|
Leveraging In-Pharmacy Education to Improve Patient Comprehension and Access to Clinical Trials
|
ACPE, CME, IACET, RN
|
Clinical Operations
|
Kenneth A. Getz
|
|
Tue, June 25
|
8:00AM
|
Is This Trial Worth It? A Panel Discussion for Sites and Project Managers
|
CME, IACET, PMI, RN
|
Clinical Operations
|
Rodney William Butt
|
|
Tue, June 25
|
8:00AM
|
Innovation and Evolution Within the Medical Science Liaison Role
|
IACET
|
Medical Communication, Medical Writing and Medical Science Liaison
|
J. Lynn Bass
|
|
Tue, June 25
|
8:00AM
|
Ethical Issues in Clinical Trials
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Art Gertel
|
|
Tue, June 25
|
8:00AM
|
GCP and Inspection Readiness
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Marta Haley Fields
|
|
Tue, June 25
|
8:00AM
|
The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Anne B. Cropp
|
|
Tue, June 25
|
8:00AM
|
Careers Beyond Project and Portfolio Management: A Panel Discussion
|
IACET, PMI
|
Project/Portfolio Management and Strategic Planning
|
Leigh Shultz
|
|
Tue, June 25
|
8:00AM
|
Making CRO-Sponsor Partnerships Work: Executive Roundtable
|
IACET, PMI
|
Innovative Partnering Models and Outsourcing Strategies
|
Kenneth I. Kaitin
|
|
Tue, June 25
|
8:00AM
|
The Thorough QT Study: Isn’t There a Better Way to Do This?
|
ACPE, CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Jay W Mason
|
|
Tue, June 25
|
8:00AM
|
Postmarket Surveillance Issues for Medical Devices
|
ACPE, CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Kirsten H. Paulson
|
|
Tue, June 25
|
8:00AM
|
Payer Collaborations with Pharma: Real-world Evidence to Improve Patient Outcomes and Influence the Pipeline
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Christopher M. Marrone
|
|
Tue, June 25
|
8:00AM
|
Biomarkers for Drug Development: How Are We Dealing with the Challenges?
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Sue-Jane Wang
|
|
Tue, June 25
|
8:00AM
|
Developing and Embracing a Culture of Quality in the Pharmaceutical Industry
|
ACPE, CME, IACET, RN
|
Pharmaceutical Quality
|
Mary Oates
|
|
Tue, June 25
|
8:00AM
|
DNA of Entrepreneurs: Calculated Risk-taking and Bringing Game-changing Technology to the World
|
CME, IACET, RN
|
Professional Development
|
Leslie J Williams
|
|
Tue, June 25
|
8:00AM
|
Data from Everyone: Using Smartphones and the Internet to Connect with Subjects
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Anne M. Zielinski
|
|
Tue, June 25
|
8:00AM
|
Development of a New Patient-reported Outcome (PRO) Measure for Depression: Progress and Results from the PRO Consortium
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Stephen Joel Coons
|
|
Tue, June 25
|
8:00AM
|
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
|
CME, IACET, RN
|
Global Regulatory
|
Nobumasa Nakashima
|
|
Tue, June 25
|
8:00AM
|
Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Judith M. Kramer
|
|
Tue, June 25
|
8:00AM
|
Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Arpad Simon
|
|
Tue, June 25
|
8:00AM
|
A Regulatory Perspective of Biosimilars in Emerging Markets
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Linda F. Bowen
|
|
Tue, June 25
|
8:00AM
|
Expediting Drug Development and Review for Serious Conditions
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Robert J. Temple
|
|
Tue, June 25
|
8:00AM
|
Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
|
CME, IACET, RN
|
Communities Showcase
|
Margaret Gurian
|
|
Tue, June 25
|
8:00AM
|
Research Advances for Rare Diseases and Orphan Products
|
ACPE, CME, IACET, RN
|
Rare/Orphan Diseases
|
Peter L. Saltonstall
|
|
Tue, June 25
|
8:00AM
|
Moving to a Standards-based, Agile Clinical Development Lifecycle
|
|
White Paper Showcase
|
Julie Smiley
|
|
Tue, June 25
|
10:15AM
|
FDA Enforcement Update: Advertising and Promotion
|
ACPE, CME, IACET, RN
|
Regulation of Product Advertising and Marketing in an Ever-changing World
|
Wayne L. Pines
|
|
Tue, June 25
|
10:15AM
|
Optimizing Trial Feasibility by Leveraging Electronic Health Record (EHR) Data and Engaging Investigators and Patient Advocacy Groups
|
ACPE, CME, IACET, RN
|
Clinical Operations
|
Lisa Palladino Kim
|
|
Tue, June 25
|
10:15AM
|
Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Pamela Lindroos
|
|
Tue, June 25
|
10:15AM
|
Domestic and Global Trends in Clinical Trial Budgeting
|
CME, IACET, PMI, RN
|
Clinical Operations
|
Frank J Cattie
|
|
Tue, June 25
|
10:15AM
|
Effective Diverse Team Collaboration and Management for Drug Development: Key Commonalities and Differences among Korea, China and Japan
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Atsushi Tsukamoto
|
|
Tue, June 25
|
10:15AM
|
Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes
|
CME, IACET, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Bill Leslie
|
|
Tue, June 25
|
10:15AM
|
Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient?
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Owen N. Charles
|
|
Tue, June 25
|
10:15AM
|
Measuring the Impact of Subject Dual Enrollment on Study Data Validity and a Web-based Tool to Avoid Simultaneous Participation in Multiple Concurrent Clinical Trials
|
CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Darran Boyer
|
|
Tue, June 25
|
10:15AM
|
Big Data: Impact on Innovation
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Susan Dentzer
|
|
Tue, June 25
|
10:15AM
|
Statistical Considerations When Developing Antibacterial Treatments
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Rima Izem
|
|
Tue, June 25
|
10:15AM
|
Advanced Presentation Skills
|
IACET
|
Professional Development
|
Lauren Edelstein Henry
|
|
Tue, June 25
|
10:15AM
|
Strategies for the Development and Registration of Antibody Drug Conjugates
|
ACPE, CME, IACET, RN
|
Pharmaceutical Quality
|
Sarah C. Pope Miksinski
|
|
Tue, June 25
|
10:15AM
|
EU Update: PROTECT and EnCePP
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Stella C.F. Blackburn
|
|
Tue, June 25
|
10:15AM
|
The Aging Population: Approaches to Ensure Safety and Efficacy
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Francesca Cerreta
|
|
Tue, June 25
|
10:15AM
|
DIA 2013 Student Forum: Getting a Job and Developing a Career
|
IACET
|
Professional Development
|
Danny A. Benau
|
|
Tue, June 25
|
10:15AM
|
Achieving Innovative Technology Results
|
CME, IACET, RN
|
Communities Showcase
|
James O'Keefe
|
|
Tue, June 25
|
10:15AM
|
Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology
|
|
White Paper Showcase
|
Kenneth J. Pennline
|
|
Tue, June 25
|
12:15PM
|
Cambridge Semantics Innovation Theater: How Can Technology Change the Way Pharmas Handle Risk? Innovations in Drug Safety and Business Development
|
|
Innovation Theater
|
Cambridge Semantics
|
|
Tue, June 25
|
1:45PM
|
Drug Development for Commercial Success
|
CME, IACET, RN
|
Regulation of Product Advertising and Marketing in an Ever-changing World
|
Michele L. Sharp
|
|
Tue, June 25
|
1:45PM
|
Enrollment Analytics: Moving Beyond the Funnel
|
CME, IACET, RN
|
Clinical Operations
|
Paul Ivsin
|
|
Tue, June 25
|
1:45PM
|
The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits
|
IACET
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Julia Cooper
|
|
Tue, June 25
|
1:45PM
|
Taking the Measure of Metrics
|
CME, IACET, PMI, RN
|
Clinical Operations
|
Nikki Dowlman
|
|
Tue, June 25
|
1:45PM
|
GCP Risk-based Monitoring
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Kathleen Goin
|
|
Tue, June 25
|
1:45PM
|
Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions
|
ACPE, IACET
|
Project/Portfolio Management and Strategic Planning
|
Michael A. Swit
|
|
Tue, June 25
|
1:45PM
|
Approaches to Quality Risk Management: Understanding What Matters
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Martin Landray
|
|
Tue, June 25
|
1:45PM
|
Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Mary Ann Sellers
|
|
Tue, June 25
|
1:45PM
|
FDA Collaborations Broaden the Reach of Health Care Messages to Effectively Communicate with the Public
|
ACPE, CME, IACET, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Anna M Fine
|
|
Tue, June 25
|
1:45PM
|
Human Abuse Liability Testing in CNS Drug Development
|
ACPE, CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Lynn Roy Webster
|
|
Tue, June 25
|
1:45PM
|
Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges
|
CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Janet Jenkins-Showalter
|
|
Tue, June 25
|
1:45PM
|
Looking Closer into the Utility of Adaptive Approaches
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Sue-Jane Wang
|
|
Tue, June 25
|
1:45PM
|
Is There a Recipe for Successful Implementation of Registries for Rare Diseases?
|
ACPE, CME, IACET, RN
|
Rare/Orphan Diseases
|
Martine Zimmermann
|
|
Tue, June 25
|
1:45PM
|
Changing View of Electronic Data Capture (EDC) and Implications for Data Quality
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Laurie S. Callen
|
|
Tue, June 25
|
1:45PM
|
Innovative Computerized System Validation and Auditing
|
CME, IACET, PMI, RN
|
Processes and Technologies for Clinical Research
|
Frances E. Nolan
|
|
Tue, June 25
|
1:45PM
|
Convergence in Regulatory Science Across the Strait
|
CME, IACET, RN
|
Global Regulatory
|
Ning Li
|
|
Tue, June 25
|
1:45PM
|
Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-risk Evaluations
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Reingart Bordel
|
|
Tue, June 25
|
1:45PM
|
Quality Assurance for Signal Detection Programs
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Elizabeth E. Garrard
|
|
Tue, June 25
|
1:45PM
|
US and EU Regulatory Update of Clinical Trial Disclosure
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Barbara Godlew
|
|
Tue, June 25
|
1:45PM
|
Electronic Submissions in PDUFA V
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Nancy D. Smith
|
|
Tue, June 25
|
1:45PM
|
Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Stuart Walker
|
|
Tue, June 25
|
1:45PM
|
Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation
|
CME, IACET, RN
|
Executive Program
|
Kenneth I. Kaitin
|
|
Tue, June 25
|
1:45PM
|
First-in-Human Studies: How Much Complexity Is Too Much?
|
CME, IACET, RN
|
Communities Showcase
|
Royce A. Morrison
|
|
Tue, June 25
|
1:45PM
|
Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers
|
|
White Paper Showcase
|
Matt Gross
|
|
Tue, June 25
|
4:00PM
|
Product Communications in the Preapproval Phase
|
CME, IACET, RN
|
Regulation of Product Advertising and Marketing in an Ever-changing World
|
Mark Gaydos
|
|
Tue, June 25
|
4:00PM
|
Approaches to Risk-based Monitoring
|
CME, IACET, RN
|
Clinical Operations
|
Jeffrey S. Handen
|
|
Tue, June 25
|
4:00PM
|
Evaluating Sites for Optimum Site Selection and Performance
|
CME, IACET, PMI, RN
|
Clinical Operations
|
Scott R Martin
|
|
Tue, June 25
|
4:00PM
|
Protocol Trends and Strategies for Quality
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Linda Fossati Wood
|
|
Tue, June 25
|
4:00PM
|
Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet?
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Nancy Bradish Myers
|
|
Tue, June 25
|
4:00PM
|
GCPs in Emerging Countries
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Fred Feldstein
|
|
Tue, June 25
|
4:00PM
|
Strategic Planning of the Global Program to Facilitate Regulatory Approval and Market Access
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Libbie Mansell
|
|
Tue, June 25
|
4:00PM
|
Optimizing the Transition from Preclinical to Clinical Research
|
CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Stella Stergiopoulos
|
|
Tue, June 25
|
4:00PM
|
Diagnostic Biomarker Verification and Validation: A Cost-efficient, Speed to Market Adaptive Design Clinical Trial Model
|
CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Alan J. Touch
|
|
Tue, June 25
|
4:00PM
|
Utilizing Electronic Medical Records as an Innovative Methodology for Evaluating Therapeutic Effectiveness
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Ryan Gifford
|
|
Tue, June 25
|
4:00PM
|
Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot
|
IACET
|
Pharmaceutical Quality
|
Evdokia Korakianiti
|
|
Tue, June 25
|
4:00PM
|
Analysis Data Standards: Developing, Applying, Submitting and Reviewing
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Stephen E. Wilson
|
|
Tue, June 25
|
4:00PM
|
So You Want to Foster Innovation: A Neuroscience Primer on How Creative Ideas Arise from the Brain
|
CME, IACET, RN
|
Professional Development
|
C. Latham Mitchell
|
|
Tue, June 25
|
4:00PM
|
Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Mitra Rocca
|
|
Tue, June 25
|
4:00PM
|
Development for Rare Disease Treatments
|
CME, IACET, RN
|
Rare/Orphan Diseases
|
Jurgen Venitz
|
|
Tue, June 25
|
4:00PM
|
Real, Transparent Dialogue from Three Sponsors: Destination eTMF - Are We There Yet?
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Nancie E. Celini
|
|
Tue, June 25
|
4:00PM
|
Korea Forum: Introduction to the Korean Ministry of Food and Drug Safety (MFDS) and Government R&D Program
|
CME, IACET, RN
|
Global Regulatory
|
Yil-Seob Lee
|
|
Tue, June 25
|
4:00PM
|
Risk Management in the US, EU and Japan: The Challenges of Diversity
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Nancy A Dreyer
|
|
Tue, June 25
|
4:00PM
|
Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Charles A. Stevens
|
|
Tue, June 25
|
4:00PM
|
Labeling and Patient Medical Information (PMI)
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Lynette Hopkinson
|
|
Tue, June 25
|
4:00PM
|
Where Research, Medicine and Care Converge: A CMO Roundtable Discussion
|
ACPE, CME, IACET, RN
|
Executive Program
|
Michael Rosenblatt
|
|
Tue, June 25
|
4:00PM
|
Advanced Presentation Skills
|
IACET
|
Professional Development
|
Lauren Edelstein Henry
|
|
Tue, June 25
|
4:00PM
|
The Evolving Clinical Trial Disclosure Global Landscape
|
CME, IACET, RN
|
Communities Showcase
|
Sarah Doyle Larson
|
|
Tue, June 25
|
4:00PM
|
Investigator Budgets Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Processes to Increase Productivity
|
CME, IACET, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Daniel M Ulrey
|
|
Tue, June 25
|
4:00PM
|
Four Ways to Accelerate Clinical Portfolio Strategy
|
|
White Paper Showcase
|
Larissa Comis-Tis
|
|
Tue, June 25
|
5:30PM
|
Movie Documentary: RARE
|
|
Rare/Orphan Diseases
|
Karen E. Jaffe
|
|
Wed, June 26
|
8:00AM
|
Clinical Trial Design for Optimal Patient Recruitment and Retention
|
CME, IACET, RN
|
Clinical Operations
|
William W. Gwinn
|
|
Wed, June 26
|
8:00AM
|
Understanding Operational Feasibility: A Discussion of Current Methodologies, Primary Research Limitations and Opportunities
|
CME, IACET, RN
|
Clinical Operations
|
Nicole Turner
|
|
Wed, June 26
|
8:00AM
|
Tethering the Channels of Scientific and Medical Content
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
J. Lynn Bass
|
|
Wed, June 26
|
8:00AM
|
Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Karen E. Jaffe
|
|
Wed, June 26
|
8:00AM
|
How Will Risk-adapted Clinical Trials Be Inspected?
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
John Poland
|
|
Wed, June 26
|
8:00AM
|
Cost Management for Global Drug Development Projects
|
CME, IACET, PMI, RN
|
Project/Portfolio Management and Strategic Planning
|
Mark A. Kryah
|
|
Wed, June 26
|
8:00AM
|
Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Barbara Leishman
|
|
Wed, June 26
|
8:00AM
|
Evolving to Functional Service Providers (FSP): Successfully Transforming Existing Partnerships into FSP Relationships
|
IACET
|
Innovative Partnering Models and Outsourcing Strategies
|
Andrew Townshend
|
|
Wed, June 26
|
8:00AM
|
Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology
|
IACET
|
Innovative Partnering Models and Outsourcing Strategies
|
Badri Rengarajan
|
|
Wed, June 26
|
8:00AM
|
Molecular Imaging: Utilizing It as an Effective Drug Development Tool
|
ACPE, CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Todd E. Peterson
|
|
Wed, June 26
|
8:00AM
|
How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)
|
ACPE, CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Michael A. Swit
|
|
Wed, June 26
|
8:00AM
|
The Environment for Health Care Decision-making: Collecting, Using and Understanding Comparative Effectiveness Research
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Kimberly Westrich
|
|
Wed, June 26
|
8:00AM
|
Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Susan P. Duke
|
|
Wed, June 26
|
8:00AM
|
How to Prepare for Meetings, Both Internal and with the FDA
|
CME, IACET, RN
|
Pharmaceutical Quality
|
Antoinette Paone
|
|
Wed, June 26
|
8:00AM
|
Current Developments in the Automated NDA Field Alert Reporting Project
|
CME, IACET, RN
|
Pharmaceutical Quality
|
Mark W. Browning
|
|
Wed, June 26
|
8:00AM
|
How Economic and Technological Change Can Affect Professional Expectations: Case Studies in Succeeding in the Midst of Change
|
CME, IACET, RN
|
Professional Development
|
Elizabeth Lincoln
|
|
Wed, June 26
|
8:00AM
|
Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
J. Jason Lundy
|
|
Wed, June 26
|
8:00AM
|
Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Ron Fitzmartin
|
|
Wed, June 26
|
8:00AM
|
Models for Genomic Research Success: Empowering Patient-Researcher Relationships and the Emerging Role of Crowd Sourcing in Rare Disease Research
|
CME, IACET, RN
|
Rare/Orphan Diseases
|
Cheng-Ho Lin
|
|
Wed, June 26
|
8:00AM
|
Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Niklas Noren
|
|
Wed, June 26
|
8:00AM
|
Pharmacovigilance Update for Japan, Developing Asia and Latin America
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Stewart Geary
|
|
Wed, June 26
|
8:00AM
|
Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions
|
IACET
|
Regulatory Affairs and Submissions
|
Janel Demeter
|
|
Wed, June 26
|
8:00AM
|
FDASIA: Impact of New Legislative Provisions on Innovative Drug Development
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Janet Jenkins-Showalter
|
|
Wed, June 26
|
8:00AM
|
FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall
|
CME, IACET, RN
|
Global Regulatory
|
Louise Dery
|
|
Wed, June 26
|
8:00AM
|
Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
|
CME, IACET, RN
|
Communities Showcase
|
Helle Gawrylewski
|
|
Wed, June 26
|
8:00AM
|
Collaborating to Streamline Drug Development: Are We Making Progress?
|
CME, IACET, RN
|
Late Breaker
|
Douglas J. Peddicord
|
|
Wed, June 26
|
10:15AM
|
Globalization of Medical Communications/Medical Science Liaisons: A Comparison of Guidance and Practice Differences
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Thomas M. Gesell
|
|
Wed, June 26
|
10:15AM
|
Study Startup Symposium
|
CME, IACET, RN
|
Clinical Operations
|
Mary Jo Lamberti
|
|
Wed, June 26
|
10:15AM
|
Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Barry A. Berger
|
|
Wed, June 26
|
10:15AM
|
Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives
|
CME, IACET, RN
|
Clinical Operations
|
Donna W. Dorozinsky
|
|
Wed, June 26
|
10:15AM
|
Driven by Data: More Effective Strategies to Reach Your Patient Recruitment Goals
|
CME, IACET, RN
|
Clinical Operations
|
Julie Parmelee
|
|
Wed, June 26
|
10:15AM
|
So You Want to Be a Project Manager: How to Find Your Way to a Challenging and Rewarding Career
|
IACET
|
Project/Portfolio Management and Strategic Planning
|
Karla Childers
|
|
Wed, June 26
|
10:15AM
|
Project Data Sphere: Clinical Trial Data-sharing in Cancer to Accelerate Innovation and Enhance Patient Health
|
ACPE, CME, IACET, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Angela L Lightfoot
|
|
Wed, June 26
|
10:15AM
|
Innovative Strategies for Evolving Sponsor, CRO and Site Alliances
|
IACET, PMI
|
Innovative Partnering Models and Outsourcing Strategies
|
Mick O'Quigley
|
|
Wed, June 26
|
10:15AM
|
Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development
|
CME, IACET, RN
|
Nonclinical and Translational Development/Early Phase Clinical Development
|
Royce A. Morrison
|
|
Wed, June 26
|
10:15AM
|
Drug Shortages: Causes, Current State and Path Forward
|
ACPE, CME, IACET, RN
|
Pharmaceutical Quality
|
Marta E. Wosinska
|
|
Wed, June 26
|
10:15AM
|
EDC Insights: Before, During, and After
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Maryanne C. Nicosia
|
|
Wed, June 26
|
10:15AM
|
Advancing Endpoint Adjudication
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Jonathan Seltzer
|
|
Wed, June 26
|
10:15AM
|
A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
David Passov
|
|
Wed, June 26
|
10:15AM
|
Advancing Alzheimer’s Innovation: A Call to Action
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Meryl Comer
|
|
Wed, June 26
|
10:15AM
|
Successful Mentoring Relationships
|
CME, IACET, RN
|
Professional Development
|
Yasmin de Faria Krim
|
|
Wed, June 26
|
12:15PM
|
SAS Innovation Theater: Picture This: Bringing Clinical Data to Life
|
|
Innovation Theater
|
SAS Institute Inc.
|
|
Wed, June 26
|
1:45PM
|
Submitting an Abstract for the DIA 2014 50th Annual Meeting
|
IACET
|
Professional Development
|
Julie Ho
|
|
Wed, June 26
|
1:45PM
|
Recent Corporate Integrity Agreements: Impact on Industry-sponsored Publications and Medical Communications Activities
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Monica A. Kwarcinski
|
|
Wed, June 26
|
1:45PM
|
The Science of Compliance
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Patrick C. O'Brien
|
|
Wed, June 26
|
1:45PM
|
Using Big Data to Design Smarter Studies
|
CME, IACET, RN
|
Clinical Operations
|
Jane E. Myles
|
|
Wed, June 26
|
1:45PM
|
FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Cynthia Kleppinger
|
|
Wed, June 26
|
1:45PM
|
Challenges and Strategic Approaches to Biosimilar Development
|
ACPE, CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Jayanthi Reddy
|
|
Wed, June 26
|
1:45PM
|
Using Competence Models to Drive High Quality Drug Project Management
|
CME, IACET, PMI, RN
|
Project/Portfolio Management and Strategic Planning
|
Peter Harpum
|
|
Wed, June 26
|
1:45PM
|
Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Deborah Chee
|
|
Wed, June 26
|
1:45PM
|
Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics
|
ACPE, CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Paul Sheives
|
|
Wed, June 26
|
1:45PM
|
The 2012 US Payer Landscape: Results from a Survey of Medical and Pharmacy Directors on Comparative Effectiveness Research
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Richard Alan Brook
|
|
Wed, June 26
|
1:45PM
|
Clinical Trial Simulations and Modeling
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
David A. Amato
|
|
Wed, June 26
|
1:45PM
|
Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective
|
ACPE, CME, IACET, RN
|
Pharmaceutical Quality
|
Moheb M. Nasr
|
|
Wed, June 26
|
1:45PM
|
Transition from Subject Matter Expert (SME) to Subject Matter Educator Extraordinaire (SMEE)!
|
CME, IACET, RN
|
Professional Development
|
Kristina R Barkhouser
|
|
Wed, June 26
|
1:45PM
|
Cloud Technology for Decision Makers: What’s Real and How to Validate It
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Teri E. Stokes
|
|
Wed, June 26
|
1:45PM
|
Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market
|
CME, IACET, RN
|
Rare/Orphan Diseases
|
Cecil J. Nick
|
|
Wed, June 26
|
1:45PM
|
Canadian Approaches to Regulatory Modernization and International Engagement
|
CME, IACET, RN
|
Global Regulatory
|
Agnes V. Klein
|
|
Wed, June 26
|
1:45PM
|
An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Ram Tiwari
|
|
Wed, June 26
|
1:45PM
|
FDASIA Patient Provisions: One Year Later
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
James E. Valentine
|
|
Wed, June 26
|
1:45PM
|
eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation
|
IACET
|
Regulatory Affairs and Submissions
|
Daniel F. Orfe
|
|
Wed, June 26
|
1:45PM
|
Advancing Alzheimer's Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Robert Feeney
|
|
Wed, June 26
|
1:45PM
|
Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers
|
ACPE, CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Rebecca D. Kush
|
|
Wed, June 26
|
1:45PM
|
Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs
|
ACPE, CME, IACET, RN
|
Communities Showcase
|
Melvyn Greberman
|
|
Wed, June 26
|
1:45PM
|
TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
|
CME, IACET, RN
|
Late Breaker
|
Craig A Wozniak
|
|
Wed, June 26
|
4:00PM
|
Learnings from Safety Communications Across the Industry: Patients and EMA, REMS and FDA, Physicians and Medical Information Groups
|
ACPE, CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Stacey M. Fung
|
|
Wed, June 26
|
4:00PM
|
Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Florence Houn
|
|
Wed, June 26
|
4:00PM
|
Innovative Ways of Working with Patients to Make Clinical Research More Productive, Less Costly and Less Burdensome for the Patient
|
CME, IACET, RN
|
Clinical Operations
|
Elisa F. Cascade
|
|
Wed, June 26
|
4:00PM
|
Overcoming Unique Challenges of Pediatric Studies
|
CME, IACET, RN
|
Clinical Operations
|
Kathryn Elaine Bohannon
|
|
Wed, June 26
|
4:00PM
|
Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Denise A Calaprice-Whitty
|
|
Wed, June 26
|
4:00PM
|
Pharmacometric Methods: Essential for Optimal Drug Development Strategy
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Royce A. Morrison
|
|
Wed, June 26
|
4:00PM
|
Pharmaceutical Project Management: What's Really Important and How Can We Do Better?
|
IACET, PMI
|
Project/Portfolio Management and Strategic Planning
|
John Z. Sun
|
|
Wed, June 26
|
4:00PM
|
Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Anupama Ramkumar
|
|
Wed, June 26
|
4:00PM
|
Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors
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CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Kevin B. Johnson
|
|
Wed, June 26
|
4:00PM
|
Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management
|
CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Larry Liberti
|
|
Wed, June 26
|
4:00PM
|
Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Surya P. Chitra
|
|
Wed, June 26
|
4:00PM
|
Ensuring Patient-centered Care: Partnering with Patient Advocacy
|
ACPE, CME, IACET, RN
|
Professional Development
|
Vicki Breitbart
|
|
Wed, June 26
|
4:00PM
|
Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective
|
ACPE, CME, IACET, RN
|
Pharmaceutical Quality
|
Christine M. V. Moore
|
|
Wed, June 26
|
4:00PM
|
Clinical Trial Visit of the Future: Leveraging Emerging Technologies to Crack the Patient Recruitment Challenge
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Komathi Stem
|
|
Wed, June 26
|
4:00PM
|
Data Standards Strategy
|
CME, IACET, PMI, RN
|
Processes and Technologies for Clinical Research
|
Stephen E. Wilson
|
|
Wed, June 26
|
4:00PM
|
Rescuing and Repurposing Drugs: Challenges and Opportunities
|
CME, IACET, RN
|
Rare/Orphan Diseases
|
Cindy Luxhoj Hahn
|
|
Wed, June 26
|
4:00PM
|
Challenges for Stable Supply of Drugs and International Cooperation
|
ACPE, CME, IACET, RN
|
Global Regulatory
|
Nobumasa Nakashima
|
|
Wed, June 26
|
4:00PM
|
Latin America Town Hall
|
CME, IACET, RN
|
Global Regulatory
|
Alejandro Bermudez-del-Villar
|
|
Wed, June 26
|
4:00PM
|
Herbal-induced Liver Injury (HILI): How That May Impact Rx Benefit-Risk
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Pradip K. Paul
|
|
Wed, June 26
|
4:00PM
|
Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Robyn R. Lim
|
|
Wed, June 26
|
4:00PM
|
Global Pediatric Development: Next Steps
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Chin Koerner
|
|
Wed, June 26
|
4:00PM
|
Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor’s Organization: Retooling R&D for ERS
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Peter M. Lassoff
|
|
Wed, June 26
|
4:00PM
|
Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges
|
ACPE, CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Andrew Satlin
|
|
Wed, June 26
|
4:00PM
|
Ethical Issues in Clinical Trials
|
ACPE, CME, IACET, RN
|
Public Policy/ Health Care Compliance/ Law
|
Art Gertel
|
|
Wed, June 26
|
4:00PM
|
Current Regulatory Landscape Impacting Medical and Scientific Communications
|
ACPE, CME, IACET, RN
|
Communities Showcase
|
Mary K. Sendi
|
|
Wed, June 26
|
4:00PM
|
Collaborative Approach for Site Qualification and Training Efficiencies
|
CME, IACET, RN
|
Late Breaker
|
Megan Schaeffer
|
|
Wed, June 26
|
5:30PM
|
Movie Documentary: Here.Us.Now.
|
|
Rare/Orphan Diseases
|
Lesa Mitchell
|
|
Thu, June 27
|
9:00AM
|
Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Tamar S. Yarkoni
|
|
Thu, June 27
|
9:00AM
|
Parents as Partners: Engaging Caregivers for Pediatric Trials
|
CME, IACET, RN
|
Clinical Operations
|
Donald Sickler
|
|
Thu, June 27
|
9:00AM
|
Hot Topics in Clinical Supplies
|
IACET
|
Clinical Operations
|
Chuck Harris
|
|
Thu, June 27
|
9:00AM
|
eSource Symposium
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Edward Stephen Seguine
|
|
Thu, June 27
|
9:00AM
|
Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries
|
ACPE, CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Noriaki Murao
|
|
Thu, June 27
|
9:00AM
|
Strategic Partnerships: Emerging Models and Their Impact on Drug Development
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Neil Ferguson
|
|
Thu, June 27
|
9:00AM
|
Medical Devices Global Symposium
|
CME, IACET, RN
|
Medical Devices, In Vitro Diagnostics, and Combination Products
|
Ekopimo O. Ibia
|
|
Thu, June 27
|
9:00AM
|
Patient-centered Predictive Modeling and Its Role in Creating a Learning Health System
|
ACPE, CME, IACET, RN
|
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
|
Matthew D. Rousculp
|
|
Thu, June 27
|
9:00AM
|
Postapproval Change Management: Challenges and Opportunities
|
CME, IACET, RN
|
Pharmaceutical Quality
|
Christine M. V. Moore
|
|
Thu, June 27
|
9:00AM
|
Some Innovative Approaches to Handling Missing Data Problems in Clinical Trials
|
CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
Peiling Yang
|
|
Thu, June 27
|
9:00AM
|
Mobile Learning and Social Media Symposium
|
CME, IACET, RN
|
Professional Development
|
Pamela Loughner
|
|
Thu, June 27
|
9:00AM
|
eDM From Three Sponsors
|
IACET
|
Processes and Technologies for Clinical Research
|
Bhanu Bahl
|
|
Thu, June 27
|
9:00AM
|
The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value
|
CME, IACET, RN
|
Rare/Orphan Diseases
|
Charles A. Stevens
|
|
Thu, June 27
|
9:00AM
|
Changing Landscape of IT in the Pharmaceutical Industry
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Pamela Campbell
|
|
Thu, June 27
|
9:00AM
|
CDER Town Hall: Part 1 of 2
|
CME, IACET, RN
|
Global Regulatory
|
Nancy D. Smith
|
|
Thu, June 27
|
9:00AM
|
Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can?
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Mitch Miller
|
|
Thu, June 27
|
9:00AM
|
Coding with Confidence
|
CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Judy E. Harrison
|
|
Thu, June 27
|
9:00AM
|
NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Shun Jin
|
|
Thu, June 27
|
10:45AM
|
Insights into China: Practical Tips for Writing Publication and Regulatory Documents
|
CME, IACET, RN
|
Medical Communication, Medical Writing and Medical Science Liaison
|
Julie A. Ely
|
|
Thu, June 27
|
10:45AM
|
Impact and Interventions Related to FDASIA: Increasing Diversity in Clinical Trials
|
CME, IACET, RN
|
Clinical Operations
|
Brenda Jamerson
|
|
Thu, June 27
|
10:45AM
|
CRA’s Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
|
CME, IACET, RN
|
Clinical Operations
|
Maria del Pilar Torres
|
|
Thu, June 27
|
10:45AM
|
Protocol Deviations: Avoidable Problems or an Unavoidable Risk
|
CME, IACET, RN
|
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
|
Leslie M. Sam
|
|
Thu, June 27
|
10:45AM
|
The Importance of Country Selection in Clinical Study Design
|
CME, IACET, RN
|
Project/Portfolio Management and Strategic Planning
|
Joan M Meyer
|
|
Thu, June 27
|
10:45AM
|
Transforming Relationships to Adapt to Evolving Organizational Strategic Goals
|
CME, IACET, PMI, RN
|
Innovative Partnering Models and Outsourcing Strategies
|
Alison Holland
|
|
Thu, June 27
|
10:45AM
|
Bayesian Methods in Medical Product Development and Comparative Effectiveness
|
ACPE, CME, IACET, RN
|
Statistical Science and Quantitative Thinking
|
David Ohlssen
|
|
Thu, June 27
|
10:45AM
|
Cultural Awareness and Collaboration
|
CME, IACET, RN
|
Professional Development
|
Gary M. Bufferd
|
|
Thu, June 27
|
10:45AM
|
Emerging Electronic Tools in Cardiovascular Outcomes Studies
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Jonathan Plehn
|
|
Thu, June 27
|
10:45AM
|
Implementing a Paperless Trial for Phase 3: A Biotech’s Lessons Learned
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Mary R. Flack
|
|
Thu, June 27
|
10:45AM
|
What's the Point? Can Point of Care Devices Enhance Clinical Trials?
|
CME, IACET, RN
|
Processes and Technologies for Clinical Research
|
Erin Iturriaga
|
|
Thu, June 27
|
10:45AM
|
CDER Town Hall: Part 2 of 2
|
CME, IACET, RN
|
Global Regulatory
|
Nancy D. Smith
|
|
Thu, June 27
|
10:45AM
|
Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations
|
ACPE, CME, IACET, RN
|
Clinical Safety and Pharmacovigilance
|
Jeffrey Heilbraun
|
|
Thu, June 27
|
10:45AM
|
Certificate of Pharmaceutical Product (CPPs): How Can the Process for Obtaining from and Submitting to Health Authorities Be Made More Efficient? Moving from Ribbons and Wax to Electronic Solutions
|
CME, IACET, RN
|
Regulatory Affairs and Submissions
|
Fraser McKillop Stodart
|