DIA 46th Annual Meeting

PAREXEL and Perceptive Informatics will be exhibiting at the 46th DIA Annual Meeting (June 13-17, 2010 in Washington DC.) Visit us at booths 917 & 921.

PAREXEL Presentations

Sunday, June 13
TUTORIAL: A Device Primer: 510(k)s, PMAs, IDEs
Barry Sall, Principal Consultant

Monday, June 14, 10:30 am - 12:00 pm
Scientific Basis for Clinical and Regulatory Requirements of Drug Fixed Combination Products
Hoss Dowlat, Esq., PhD, Vice President, Global Strategy

Monday, June 14 10:30 am - 12:00 pm
Application of Competency Model in Matching, Managing, and Monitoring Writer Competencies
James Wolfe, PhD, MS, Associate Director, Medical Writing Services, Europe

Monday, June 14, 1:30 pm - 3:00 pm
Key Considerations for Global Development Strategies for Biologics
Hoss Dowlat, Esq., PhD, Vice President, Global Strategy

Monday, June 14, 1:30 pm - 3:00 pm
Going for BRIC: Accessing Emerging Markets and Japan Before or After US and EU Registration
Alberto Grignolo, PhD, Corporate Vice President Global Strategy and Services

Monday, June 14, 3:30 pm - 5:00 pm
Partnering to Innovate and Overcome the Limitations of Conformity and the Path of Least Resistance
Drew Garty, Senior Director, Worldwide eClinical Solutions

Monday, June 14, 3:30 pm - 5:00 pm
Deal Makers and Deal Breakers: Comparative Effectiveness Considerations in VC Funding Decisions
Alberto Grignolo, PhD, Corporate Vice President Global Strategy and Services
Charles Stevens, Vice President & General Manager, Reimbursement & Market Access

Monday, June 14, 3:30 pm - 5:00 pm
How Metadata Repositories Are Used: From the Investigators and Data Collection to the Data Warehouse
Terry Hardin, Senior eTrial Architect

Monday, June 14, 3:30 pm - 5:00 pm
Centralized Monitoring: When Does It Make Sense?
Ramita Tandon, Senior Director, Operations

Tuesday, June 15, 10:00 am - 11:30 am
Parallel Lines Eventually Intersect: Evolution of Technologies in Parallel Industries
David Stein, Senior Director, Product Management, Perceptive Informatics

Tuesday, June 15, 2:00 pm - 3:30 pm
Protocol Change: Site Implications
Selena Farrar, MPH, RN, Clinical Operations Manager

Tuesday, June 15, 4:00 pm - 5:30 pm
Simplifying Supplies Forecasting and Study Implementation Using Clinical Trial Technologies
Bill Byrom, Senior Director, Product Strategy, Perceptive Informatics

Tuesday, June 15, 4:00 pm - 5:30 pm
Risk-Based Monitoring: Mitigation Strategies and Process Control
Holger Liebig, Senior Director, Project Management

Tuesday, June 15, 4:00 pm - 5:30 pm
Clinical Trial Requirements
Cecil Nick, Vice President, Biotechnology

Wednesday, June 16, 10:30 am - 12:00 pm
Negotiating Regulatory Hurdles in Vaccine and Adjuvant Development and Licensure
Judith Atkins, Principal Consultant
Nancy Kirschbaum, Senior Consultant

Wednesday, June 16, 10:30 am - 12:00 pm
Progress Towards a US Regulatory Pathway for Follow-on Biologics
Bruce  Babbitt, PhD, Principal Consultant

Wednesday, June 16, 1:30 pm - 3:00 pm
Experiences with Outsource Partnering for eCTD Production: A Global Contract Services Organization’s Experience
Lynn Stillman, Principal Consultant

Wednesday, June 16, 3:30 pm - 5:00 pm
Immunogenicity Assays for Therapeutic Antibodies
Ralf Dieter Hess, Principal Consultant

Wednesday, June 16, 8:30 am - 10:00 am
Rethinking the Study Feasibility Assessment Process to Ensure Successful Study Implementation
Lars-Olof Eriksson, Vice President, Global Research Operations

Wednesday, June 16, 8:30 am - 10:00 am
Global Market Access and Reimbursement Strategies
Rick Morton, Senior Director

Wednesday, June 16, 8:30 am - 10:00 am
When Is CMC Comparability Data Sufficient to Support Process Change: The EU View
Cecil Nick, Vice President, Biotechnology

Thursday, June 17, 10:30 am - 12:00 pm
Leveraging Technology to Drive Onsite Productivity
Debra Tatton, Senior Director, Global Research Operations