Drug Development Meetings
On Wednesday, Dec. 12, join FDAnews for “Drug Repositioning and the 505(b)(2) Application: A Step-by-Step Approach to a Fuller, More Profitable Pipeline.” In this 90-minute audioconference and webinar, Kenneth Phelps, president and CEO of Camargo Pharmaceutical Services, will compare the various new drug approval applications and show you when a 505(b)(2) is the best choice.
On Thursday, Dec. 13, join FDAnews for “Data Monitoring Committees: Strategies for Future Trial Design.” In this 90-minute audioconference, Jennifer Elder, Ph.D., outlines the biggest challenges in the FDA data monitoring committee (DMC) guidance, including when a DMC is necessary and how to structure the committee to help prevent issues that could attract FDA scrutiny. Also on Thursday, Dec. 13, join FDAnews for “Unlock Hidden Downtime in Pharmaceutical Manufacturing: How to Eliminate the Top Six Reasons for Production Losses.” In this 90-minute audioconference and webinar, John Oskin, executive vice president of Informance International, will detail the top six causes for production losses by analyzing the findings and providing you with the results of a study examining more than 12 years of manufacturing performance data.
Monday, Dec. 10 - Wednesday, Dec. 12, 2007
Good Clinical Practices
Malvern, Pa.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=039&source=fdancc
Monday, Dec. 10 - Tuesday, Dec. 11, 2007
Laboratory Analysis in Clinical Trials
Amsterdam, Netherlands
(732) 238-1600
The Center for Professional Advancement
info@cfpa.com
www.cfpa.com/template_courses.asp?course_name=200712102137-18a
Thursday, Dec. 13 - Friday, Dec. 14, 2007
Adverse Drug Events — Understanding and Reporting Requirements
Malvern, Pa.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=002&source=fdancc
Thursday, Dec. 13 - Friday, Dec. 14, 2007
Medical Devices — EU Directives, Guidance, CE Marking and ISO Standard Certifications
Malvern, Pa.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=092&source=fdancc
Monday, Jan. 7 - Tuesday, Jan. 8, 2008
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
Malvern, Pa.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=090&source=fdancc
Monday, Jan. 7 - Tuesday, Jan. 8, 2008
Process Validation for Drugs and Biologics
Malvern, Pa.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=049&source=fdancc
Thursday, Jan. 24 - Friday, Jan. 25, 2008
How to Monitor Clinical Trials for GCP Compliance
Costa Mesa, Calif.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=043&source=fdancc
Thursday, Jan. 24 - Friday, Jan. 25, 2008
Design Control and Product Validation
New Brunswick, N.J.
(732) 238-1600
The Center for Professional Advancement
info@cfpa.com
www.cfpa.com/200801241900-11a/1900/d/courseSummary.aspx
Thursday, Jan. 31 - Friday, Feb. 1, 2008
11th Annual Workshop in Japan for Clinical Data Management
Edogawa-ku, Japan
(215) 442-6100
Drug Information Association
dia@diahome.org
www.diahome.org
Thursday, Jan. 31 - Friday, Feb. 1, 2008
FDA Inspections of Clinical Data Systems
Dublin, Ireland
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=034&source=fdancc
Tuesday, Feb. 5, 2008
Development of a Clinical Study Report
Philadelphia, Pa.
(215) 442-6100
Drug Information Association
dia@diahome.org
www.diahome.org
Monday, March 10 – Thursday, March 13, 2008
32nd Annual International Good Manufacturing Practices Conference: “GMPs in a Changing World”
Athens, Ga.
(678) 407-5277
The University of Georgia College of Pharmacy
gdykstra@mail.rx.uga.edu
www.internationalgmp.com