DIA will host US and International Prescription Drug Labeling: Comparisons and Important Updates from December 7-9, 2010 in Washington, DC.
This first of its kind conference will explore the most pressing issues facing professionals from biopharmaceutical companies, CROs, consulting agencies, and regulatory authorities involved in labeling, clinical safety, regulatory affairs, clinical research and development, and quality control. Session topics will include:
- High Level Comparison of the Approaches to Prescription Drug Labeling and the Dissemination of Related Regulatory Information: Canada, European Union, Japan, and USA
- Important Labeling News and Developments: USA
- Comparative Review of the Indications and Clinical Studies Sections: Canada, European Union, Japan and United States
- Comparative Review of the Adverse Reactions Section: Canada, European Union, Japan and United States
- Comparative Review of the Warnings and Precautions, Contraindications, and Boxed Warnings Sections: Canada, European Union, Japan and United States
- Comparative Review of the Interactions Section: Canada, European Union, Japan, and USA
- Comparative Review of Approaches to Patient Information: Canada, European Union, Japan, and USA
Preconference tutorials will provide intense instruction on:
- The EU PIM System (Product Information Management System) from a Practical Regulatory Perspective
- Structured Product Labeling and eList
- Writing the Highlights Section of US Prescribing Information
- Writing the Boxed Warning, Contraindications, Warnings and Precautions and Adverse Reactions sections of US Prescribing Information
“Regulatory authorities from different regions will discuss issues commonly encountered by industry in an effort to advance understanding of labeling requirements across various regions,” says Steven W. Bass, PhD, President, Bass BioPharm Consulting Group, LLC.
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org