Drug Development Meetings

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Join FDAnews Tuesday, Dec. 20, for a 90-minute audioconference on "Clinical Trial Disasters: How to Plan, Prepare and Prevent Losses." Experts Cassandra Kennedy and Judith Beach draw on real-world experience to help you create and implement a disaster management plan specifically for clinical research activities. They'll walk you through five common disasters and show you step-by-step what you can do now to prepare and prevent study-ending losses. Plus, mark your calendar! Compliance Bootcamp 2006 begins Feb. 6-10, 2006, in Orlando. FDA training is available to industry through this intensive, hands-on, five-day seminar. You get three courses in one -- one based on the same computerized system validation and Part 11 training FDA gives its own inspectors plus two tightly focused sessions on systematic risk management and CAPA systems. Call for more information: +1 (703) 538-7600. Presented with EduQuest.

Jan. 4-6: Biostatistics for Non-Statisticians

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Jan. 9-10: Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Jan. 9-10: Pharmaceutical Water Systems

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Jan. 10-11: Drug Development and FDA Regulations

San Francisco, Calif.

(610) 548-2200

Barnett Educational Services

customer.service@parexel.com

www.barnettinternational.com/index-flash.html

Jan. 10-11: The EU Clinical Trial Directive

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Jan. 11-12: Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Jan. 11-13: Monitoring Clinical Drug Studies: Beginner

San Francisco, Calif.

(610) 548-2200

Barnett Educational Services

customer.service@parexel.com

www.barnettinternational.com/index-flash.html

Jan. 12-13: CHI's 3rd Annual Protein Process Development: Optimizing Protein Expressions through Scale-Up

Coronado, Calif.

(617) 630-1300

Cambridge Healthtech Institute

chi@healthtech.com

www.chi-peptalk.com

Jan. 12-13: CHI's 5th Annual Protein Arrays: Proteomic in Multiplex

Coronado, Calif.

(617) 630-1300

Cambridge Healthtech Institute

chi@healthtech.com

www.chi-peptalk.com

Jan. 12-13: European Filing and Registration Procedures

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Jan. 16-18: A Guide to Critical Process Cleaning and Cleaning Validation

Boca Raton, Fla.

(732) 238-1600

Center for Professional Advancement

info@cfpa.com

www.cfpa.com

Jan. 18: Planning and Writing High Quality Investigation Reports for Regulatory Compliance

La Jolla, Calif.

(801) 685-7717 x 306

McCulley/Cuppan LLC

jmahajan@mcculley-cuppan.com

www.mcculley-cuppan.com