The Association of Clinical Research Organizations (ACRO) is pleased to announce that more than 50 educational sessions during the 43rd Annual Drug Information Association (DIA) meeting will feature member company speakers sharing their expertise on a diverse range of clinical outsourcing topics. The meeting will be held June 17-21 in Atlanta, Georgia.
In addition to the numerous expert presentations by member company representatives, Dr. Alberto Grignolo, Corporate Vice President and General Manager for Drug Development Consulting with PAREXEL International and a past Chairman of the ACRO Ethics and Clinical Practice Committee, will serve as the 2007 DIA Chairperson.
ACRO Member Company Speakers at the DIA 43rd Annual Meeting include:
◊ Zoran Antonijevic, MSc, Senior Director, Strategic Development, Biostatistics, Quintiles
Adaptive Designs: Dealing with Practical Problem -- Control of Information Flow from a CRO Perspective
June 18 at 10:30 AM
◊ John Blakeney, MPA, Senior Director, CDM, Quintiles
Benefits and Challenges of Implementing Standards in Outsourced Studies -- Standards on Outsourced Clinical Trials: A CRO Perspective
June 19 at 8:00 AM
◊ Mary Briggs, Senior Director, Key Accounts, Kendle
Excelling as a Supervisor or Manager in the Clinical Research Industry
June 17 at 9:00 AM
Delivering Effective Feedback for Clinical Research Managers
June 20 at 1:30 PM
◊ Paula Brown Stafford, MPH, Executive Vice President, Global Data Management, Quintiles
The State of Clinical Outsourcing; Results from Avoca’s 2007 Industry Survey with a Focus on Change Orders - The Challenges, the Impact and the Effect on Relationships
June 20 at 10:30 AM
◊ Jim Burns, PhD, Senior Vice President, PharmaNet Consulting
Achieving Success in Registration; Avoiding Pitfalls in Drug Development -- Early Development: Application of Pharmacology
June 19 at 2:00 PM
◊ George Butler, Vice President, Corporate Project Management, PharmaNet
The State of Clinical Outsourcing: Results form Avoca’s 2007 Industry Survey with a Focus on Change Orders – The Challenges, the Impact and the Effect of Relationship
June 20 at 10:30 AM
◊ Julia Cooper, PhD, Senior Director, Worldwide Head of Medical Writing Services, PAREXEL International
My Drug is Approved – Now What? Overview of Required Post-Approval Documents
June 20 at 10:30 AM
◊ Dr. John Constant, Vice President, Scientific Affairs, PRA International
Meeting the Challenges for Data Monitorial Committees: The Committee Perspective
June 18 at 3:30 PM
◊ Deborah Covington, DrPH, Director, Registries & Epidemiology, Late Phase, Kendle
Developing Registries for Post-Marketing Risk Assessment: The Antiretroviral Pregnancy Registry Experience
June 19 at 10:00 AM
◊ Gerald A. Faich, MD, Sr. VP, Epidemiology & Risk Management, UBC
Avoiding Pitfalls in the Conduct of Postmarketing Trials for Safety
June 19 at 2:00 PM
◊ Alberto Grignolo, PhD, Corporate Vice President and General Manager, Drug Development Consulting, PAREXEL Consulting, 2007 DIA Chairperson
Opening Remarks/Plenary Session
June 18 at 8:30 AM
Personalized Medicine and Personalized Drug Development: Case Studies and Progress to Date
June 18 at 1:30 PM
Global Clinical Trials and Polyethnic Patient Enrollment: Implications for Regulatory Approval of Marketing Applications
June 20 at 3:30 PM
◊ Karen Grossberg, Associate Director, Clinical Research, PharmaNet
Pediatric Clinical Trials: Lessons Learned from the Field
June 19 at 10:00 AM
◊ Gerald Haase, Principal Consultant, Drug Development Consulting Practice, PAREXEL Consulting
Biosimilars in Europe: The EU Regulatory Environment for Biosimilars
June 20 at 1:30 PM
◊ Paul Hara, Director, Program Management, Development and Regulatory Services, MDS Pharma Services
Who is this Jack of All Trades: the Pharmaceutical R&D Project Manager?
June 20 at 10:30 AM
◊ Chuck Harris, Vice President, Operations, Clinical Technologies, UBC
Software User Acceptance Testing
June 19 at 4:00 PM
◊ Edward Ian, Director of Operations, Asia, PRA International
Feasibility of Implementing Competency-based Training Program in Singapore and Taiwan
June 19 at 2:00 PM
◊ Stanford S. Jhee, Director of Research, California Clinical Trials, PAREXEL International
Role of Ex-Japan Clinical Pharmacology Studies (Ethnobridging) in Expediting Japanese Drug Development
June 20 at 3:30 PM
◊ Doris Kolb, Director of Operations, Medical Affairs, PRA International
Statistical Methodologies for Safety Assessments: Key Problems in Premarketing Safety Analysis and How to Approach Them
June 20 at 10:30 AM
◊ Holger Liebig, Director of Project Management, PAREXEL International
Risk Management in Clinical Trials
June 19 at 2:00 PM
◊ Helen Lingard, PMP, Director, IT Clinical Solutions, Quintiles
The Implementation of a CTMS System -- CTMS: The CRO Challenges
June 18 at 10:30 AM
◊ Kay Mason, Senior Regulatory Affairs Manager, Quintiles
Global New Drug Development: Regulatory Challenges, Successes and Recommendations from a US-based Company
June 20 at 10:30 AM
◊ Eddie Montoya, Director, IVRS, Covance
Adaptive Trial Design: An Innovative Approach to Streamline the Clinical Supply Process
June 19 at 4:00 PM
◊ Rick Nelson, Vice President, Specialized Pharmaceutical Services, PharmaNet
The Implementation of a CTMS System
June 18 at 10:30 AM
The Challenges of Auditing an Investigational Site Using Electronic Data Capture
June 21 at 10:30 AM
◊ Cecil Nick, MS, Director, PAREXEL Consulting
Process Validation during Clinical Development of Biological Medicinal Products
June 20 at 8:30 AM
Optimizing EU Regulatory Strategy
June 20 at 10:30 AM
Quality Issues and the Spectrum of Complexity
June 20 at 3:30 PM
Gene Therapy Regulations for EU Clinical Trials: Navigating the Maze
June 21 at 8:30 AM
◊ Dr. Monika Pietrek, Executive Vice President, Scientific & Medical Affairs, PRA International
Meeting the Challenges for Data Monitoring Committees: The Clinical Research Perspective
June 18 at 3:30 PM
◊ Sarah Pniak, Clinical Operations Lead, Quintiles
The Playing Field of Project Management: A Dynamic Investigation of a Team and their Winning Strategy
June 21 at 10:30 AM
◊ Susan Ross, MD, FRCPC, Vice President, Medical Affairs, UBC
Using Electronic Medical Records for Clinical Research
June 19 at 4:00 PM
◊ Susan Sandler, Principal Consultant, PAREXEL Consulting
Compassionate Use of Supply of Unlicensed Products in Europe and Beyond
June 20 at 3:30 PM
◊ Peggy Schrammel, Executive Director, Late Stage Development, PharmaNet
Pediatric Clinical Trials: Lessons Learned from the Field
June 19 at 10:00 AM
◊ Lauren Shinaberry, MS CCDM, Manager, Clinical Data Management, PRA International
Best Practice for Implementation of EDC Standards and Technology
June 20 at 8:30 AM
◊ Kimberly Sierk, Director, Testing & Validation, Clinical Technologies, UBC
Next Generation Application Integration Using Web Services
June 18 at 10:30 AM
◊ William Sietsema, PhD, Vice President, US Regulatory Consulting and Submissions, Kendle
Effective Milestone Meetings with FDA
June 18 at 1:30 PM
◊ Philippa Smit-Marshall, MD, Executive Medical Director, PharmaNet
Risk Management in Clinical Trials
June 19 at 2:00 PM
◊ Shari Stark, Manager, QA & Compliance, PharmaNet
The Challenges of Auditing an Investigational Site Using Electronic Data Capture
June 21 at 10:30
◊ Dr. L. Paul Starkey, Senior Director, Medical Monitoring Americas, PRA International
Individual Case Safety Reports (ICSRs)—Fostering Quality Data via Stimulation of Healthcare Professional Reporting, Active Query, Applied Clinical Expertise and Efficient Case Handling
June 18 at 10:30 AM
◊ Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology & Risk Management, UBC
Evaluation of Risk Management Programs Using Existing Databases
June 17 at 1:00 PM
The Use of Patient & Disease Registries for Product Lifecycle Management
June 20 at 1:30 PM
◊ Jeffrey Stoddard, MD, Vice President, Medical & Scientific Affairs, Covance
Risk Management of Vaccine Products
June 19 at 1:00 AM
◊ Ramita Tandon, MPH, Director, Project Management, Peri-Approval Clinical Excellence, PAREXEL International
Outsourcing and Late Phase Studies: What to Do, What Not to Do & Why
June 20 at 1:30 PM
◊ Irach Taraporewala, Senior Consultant, PAREXEL Consulting
The Advantages of Quality by Design (QbD) Implementation for Emerging Companies
June 20 at 1:30 PM
◊ Karen Van Kampen, Manager, PRA Institute, PRA International
Self-guided Mentoring Program Administered by Training: Mentoring for Success: One Size Does Not Fit All
June 18 at 10:30 AM
◊ Bruce Wagman, MBA, RN, Vice President, Regulatory & Quality Assurance Services, Covance
Understanding and Mitigating the Risks Associated with an International Clinical Program
June 19 at 2:00 PM
◊ Gary Walker, Associate Regulatory Director, Global Data Management, Quintiles
Standard Controlled Terminology: A Successful Partnership between CDISC, the FDA, and NCI Enterprise Vocabulary Services
June 20 at 1:30 PM
eCTD Standards: Now and the Future
June 21 at 8:30 AM
◊ Hal Ward, RPh, PharmD, Executive Director, Global Head of Drug Safety, Covance
Developing a Multiple-Language Web-Based Training Program
June 20 at 1:30 PM
◊ Francis Wouters, DDS, PhD, Vice President, Business Development, PharmaNet
Improving CRO Negotiations to Accelerate Time to Market
June 19 at 2:00 PM
◊ Janet Zimmerman, Senior Director, Training Services, PharmaNet
Practical Models for Training Clinical Research Monitors
June 20 at 1:30 PM
◊ Robin Zumbrunnen, Director, Regulatory Operations, Quintiles
IND in eCTD Format
June 21 at 10:30 AM
Please join ACRO at Booth 2017 during DIA to learn more about the association's latest initiatives on behalf of the CRO industry worldwide. |
