FDAnews
www.fdanews.com/articles/75745-drug-development-meetings

Drug Development Meetings

August 25, 2005

Join FDAnews Tuesday, Aug. 30, for a 90-minute audioconference on "Preparing for an FDA Preapproval Inspection." Learn from FDA veteran David Barr how to prepare for and manage these inspections to avoid misunderstandings, prevent delays in the approval process, and eliminate unnecessary costs. On Aug. 31, join FDAnews for "Step-By-Step Guide to Clinical Trials: Effectively Execute a Study From Design to Audit." Gather your team together to learn from expert William Sietsema, Ph.D., as he guides you step by step on the best ways to execute a clinical trial -- from how to engineer a clinical program and organize a project team to what to do if your site is audited by the FDA.

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

Sept. 13: Laboratory Equipment Validation and Qualification

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Sept. 14-15: Innovation Boot Camp for the Pharmaceutical Industry

Palm Springs, Calif.

(714) 289-1233

Institute for Effective Innovation

info@innovationbootcamp.com

www.InnovationBootCamp.com

Sept. 14-16: Advanced Good Clinical Practices

Miami Beach, Fla.

(703) 276-0178

Peri

maria.simonetti@peri.org

www.peri.org