| Click on the session title for a complete description. |
| Day |
Session Link |
| Monday |
Where Are the Goal Posts this Week? An Update on Global Legislation Related to Clinical Trial Disclosure |
| Monday |
Medical Writer Competency Model: Understanding Skills, Knowledge, and Behaviors for Use in Hiring, Training, and Evaluating Medical Writers |
| Monday |
The New "Next Door" in Global Development: When East Goes West or West Goes East |
| Monday |
Creating Value through Fast-track Regulatory Strategies |
| Tuesday |
Regulatory Requirements for Natural Health Products/Herbal Medicinal Products in the US and EU |
| Tuesday |
Pediatric Drug Development: A Global Challenge |
| Tuesday |
Site Preferences for EDC: A Comparison of European and North American Perspectives |
| Tuesday |
Critical Decision Factors in the Allocation of Clinical Sites for Global Drug Development |
| Tuesday |
Follow-on Biologics: Ensuring Quality, Efficacy and Safety |
| Tuesday |
Development of Oncology Products in the EU and US: Can We Do Better? |
| Tuesday |
Adaptive Designs: Review of Adaptive Trials Guidance Document |
| Tuesday |
Interacting with the European Medicines Agency |
| Tuesday |
Transparency: EMEA's Future Policy |
| Tuesday |
Meet the Regulators |
| Wednesday |
New Approaches to Toxicity Testing to Support Pharmaceutical Development - Part 1 of 2: New Endpoints |
| Wednesday |
International eCTDs: An Update on Regulatory Authority Experience |
| Wednesday |
US-EU: Administrative Simplification - Status Report of Exchange of Information among Regulators |
| Wednesday |
The EU Risk Management Plan and US Risk Evaluation and Mitigation Strategy (REMS): Company Perspectives and Experience |
| Wednesday |
The Multilingual Dimension: Best Practices for Addressing Global Content and Global XML |
| Wednesday |
Experience with GCPs Worldwide |
| Wednesday |
Opportunities for the Treatment of Rare Diseases |
| Wednesday |
Managing First-in-man Studies |
| Wednesday |
Measuring Benefit and Balancing Risk: Strategies for the Benefit-risk Assessment of New Medicines in a Risk-averse Environment |
| Wednesday |
Risk Management Best Practice: Integrating Risk Management Strategies into All Phases of the Product Life Cycle |
| Wednesday |
Faster, Better, Cheaper? Working Outside North America and Western Europe |
| Wednesday |
Town Meeting: Good Auditing Practices – Internal Audits, External Audits, and the Audit Report |
| Wednesday |
An International Perspective on the Use of Computerized Systems in GCP |
| Wednesday |
Harmonization Scope for Natural Health Products Regulatory Requirements |
| Wednesday |
International Cooperation on GMP/GCP Inspections |
| Wednesday |
Relative Efficacy/Effectiveness: A New Interface between Drug Regulation and Health Technology Assessment? |
| Wednesday |
FDA and EMEA Efforts to Harmonize Primary End Points |
| Thursday |
Global Working Environment Synergy: When an American Team Leader, Japanese Project Manager and European Team Members Work Together |
| Thursday |
Updating ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals |
| Thursday |
The Role of Excipients and Quality by Design (QbD) |
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