CGMP Guidance for Phase 1 Clinical Supplies

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, June 15th, 2010. For more details or to register please visit our site at www.fxconferences.com

The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.

Global Clinical Studies: Logistical Challenges from Supply to Assay

As the nature of clinical trials becomes more complex, the focus and expertise of personnel involved has become more specialized. To manage a successful study, awareness of all aspects in this process is critical.

In this audio conference, Ms. Oliver reveals all of the logistical challenges involved in clinical studies and effectively illustrates them through two scenarios: 1) drug distribution through delivery and 2) specimen transport from patient to assay.

The topics covered will include successful strategies for the transport of cold chain including regulatory and import considerations. Also discussed will be aspects of clinical sample logistics including site and lab selection, and customs.

Global Clinical Studies: Logistical Challenges from Supply to Assay was presented by Karen Oliver, Director Global Accounts, with World Courier and aired on 2008-10-08. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Global Clinical Studies: Logistical Challenges from Supply to Assay

As the nature of clinical trials becomes more complex, the focus and expertise of personnel involved has become more specialized. To manage a successful study, awareness of all aspects in this process is critical.

In this audio conference, Ms. Oliver reveals all of the logistical challenges involved in clinical studies and effectively illustrates them through two scenarios: 1) drug distribution through delivery and 2) specimen transport from patient to assay.

Takeaways include Tips for successful logistics planning in global clinical studies, Strategies for effective clinical supply shipping, and many more. Global Clinical Studies: Logistical Challenges from Supply to Assay is presented by Karen Oliver, Director Global Accounts, of World Courier, and runs Wednesday, October 8th, 2008. For more details or to register please visit our site www.fxconferences.com