FDAnews
www.fdanews.com/articles/75519-drug-development-meetings

Drug Development Meetings

August 18, 2005

Join FDAnews Tuesday, Aug. 23, for "CDISC's Study Data Tabulation Model: Learn the Basics and Benefits of Data Standards." Experts Gary Walker and Wayne Kubick will explain what CDISC is, what the term "data standards" means, and how sponsor companies and regulatory staff can benefit from standardized data. On Aug. 30, join FDAnews for "Preparing for an FDA Preapproval Inspection." Learn how to prepare for and manage these inspections to avoid misunderstandings, prevent delays in the approval process, and eliminate unnecessary costs.

Aug. 21-23: CHI's Sixth Annual Targeted Nanodelivery for Therapeutics and Molecular Imaging Washington, D.C. (617) 630-1300 Cambridge Healthtech Institute chi@healthtech.com www.healthtech.com

Aug 22-23: Cleaning Fundamentals for the Pharmaceutical Industry Chicago, Ill. (813) 960-2105 ISPE customerservice@ispe.org www.ispe.org/GoTo_ChicagoTraining

Aug. 22-23: Fundamentals of Biochemistry: Background for Biotechnology Malvern, Pa. (610) 688-1708 The Center for Professional Innovation & Education info@cfpie.com www.cfpie.com

Aug. 29-30: CHI's Second Annual Tissue Models for Therapeutics Cambridge, Mass. (617) 630-1300 Cambridge Healthtech Institute chi@healthtech.com www.healthtech.com

Aug. 29-30: SOPs for Clinical Research Singapore (656) 835-5109 IBC Asia (S) Pte rouhyi.tham@ibcasia.com.sg www.ibc-asia.com

Aug. 31-Sept. 1: Quality Assurance and Preparing for FDA Inspection in Clinical Trials Singapore (656) 835-5109 IBC Asia (S) Pte ruohyi.tham@ibcasia.com.sg www.ibc-asia.com

Sept. 7: Designing and Writing High Quality Investigation Reports La Jolla, Calif. (801) 685-7717 x 306 McCulley/Cuppan LLC jmahajan@mcculley-cuppan.com www.mcculley-cuppan.com

Sept. 7-9: Good Clinical Practices Malvern, Pa. (610) 688-1708 The Center for Professional Innovation & Education info@cfpie.com www.cfpie.com

Sept. 8-9: AAPS Workshop on Integrated Roadmap to Biomarkers for Drug Development — Method Validation and Qualification Rockville, Md. (703) 243-2800 AAPS didawicks@aaps.org www.aapspharmaceutica.com

Sept. 12-14: 2005 PDA/FDA Joint Regulatory Conference Washington, D.C. (301) 656-5900 PDA kaminsky@pda.org www.pda.org/pdafda2005

Sept. 12-14: Good Laboratory Practices Malvern, Pa. (610) 688-1708 The Center for Professional Innovation & Education info@cfpie.com www.cfpie.com

Sept. 12-14: Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics Arlington, Va. (703) 276-0178 Peri maria.simonetti@peri.org www.peri.org