Drug Development Meetings

On Wednesday, Dec. 5, join FDAnews for “Structuring Contracts With Third-Party Manufacturers and Suppliers: Relying on Purchase Orders Can Lead to Big Risks.” In this 90-minute audioconference, Todd Gattoni, partner with the Dykema law firm, will examine the shortcomings of purchase order contracting and show you how a commercial supply agreement can minimize risks. Then, 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.

Tuesday, Dec. 4, 2007 
Achieving Value in Your Company-Sponsored Clinical Trial
Online
(215) 442-6100
Drug Information Association
dia@diahome.org
www.diahome.org

Thursday, Dec. 6 - Friday, Dec. 7, 2007 
Future Regulatory Challenges in the Quality Area
Amsterdam, Netherlands
(011) 6.1225.5136
Drug Information Association
dia@diahome.org
www.diahome.org

Thursday, Dec. 6 - Friday, Dec. 7, 2007 
6th European Validation Workshop
Amsterdam, Netherlands
(011) 6.1225.5136
Drug Information Association
dia@diahome.org
www.diahome.org

Monday, Dec. 17 - Tuesday, Dec. 18, 2007 
Process Validation Principles and Protocols
Princeton, N.J.
(800) 472-6477
STAT-A-MATRIX
knee@statamatrix.com
www.statamatrix.com/store/catalog/product_info.php/products_id/121

Monday, Jan. 14 - Tuesday, Jan. 15, 2008 
Adverse Drug Events: Understanding and Reporting Requirements
Berlin, Germany
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=002&source=fdancc

Monday, Jan. 14 - Wednesday, Jan. 16, 2008 
Eudravigilance - Electronic Reporting of ICSRs in the EEA
London, UK
(161) 225-5151
Drug Information Association
diaeurope@diaeurope.org
www.diahome.org

Monday, Jan. 21 - Wednesday, Jan. 23, 2008 
Essentials of Clinical Study Management Training Course
Nice, France
(161) 225-5151
Drug Information Association
diaeurope@diaeurope.org
www.diahome.org

Monday, Jan. 21 - Tuesday, Jan. 22, 2008 
The Effective CRA/Clinical Trial Coordinator - How to be more proactive in your role
London, UK
(148) 373-0071
Management Forum Ltd
info@management-forum.co.uk
www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=734

Monday, Feb. 11 - Tuesday, Feb. 12, 2008 
Project Management for Phase I & II Clinical Trials
Malvern, Pa.
(610) 688-1708
The Center for Professional Innovation & EducationCfPIE
info@cfpie.com
www.cfpie.com/showitem.aspx?productid=101&source=fdancc

Monday, Feb. 11 - Tuesday, Feb. 12, 2008 
Pharmaceutical Regulatory Affairs in the Middle East
London, UK
(148) 373-0071
Management Forum Ltd
info@management-forum.co.uk
www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=679

Thursday, March 27 - Friday, March 28, 2008 
New Drug Product Development and Lifecycle Management
Horsham, Pa.
(215) 442-6100
Drug Information Association
dia@diahome.org
www.diahome.org

Monday, March 10, 2008 – 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