home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences  
 

Clinical Development of Stem Cell Therapies: Scientific, Regulatory and Ethical Considerations

 
  January 26, 2010  
     
 
DIA, North Bethesda, MD 20852
Apr 12 2010 8:00AM - Apr 13 2010 5:00PM


Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852 

Interest Area(s):
CMC, Clinical Safety/Pharmacovigilance, Clinical Research, Nonclinical, Research & Development

Overview:

Strategies for Enabling the Clinical Development of Stem Cell Products.

Join representatives from academia, industry and regulatory agencies, to analyze the transitional process from discovery and regulatory approval to the therapeutic use of stem cell products. Experts will present specific examples of, and solutions for, issues related to the preclinical, CMC, and clinical stages of development for stem cell products

Learning Objectives:
At the conclusion of this conference, participants should be able to:
• Discuss US and EU regulatory requirements for stem cell products
• Outline strategies for clinical development of stem cell products
• Describe the ethical challenges surrounding stem cell research
• Compare successful product development strategies from industry case studies
• Explain CMC challenges of reagents, devices and potency


Target Audience:
Professionals involved in the development and regulation of stem cells for therapeutic use, including those involved in:
• Biotechnology
• Clinical research and development
• Clinical safety/Pharmacoepidemiology/Pharmacovigilance
• Chemistry, Manufacturing and Controls (CMC)
• • Devices
• • Nonclinical safety and efficacy/Toxicology
• • Quality control/assurance
• • Regulatory affairs/Policy/Drug or device approval/GRP
• • Research and development/Strategic issues
• • Preclinical studies
• • Clinical trials

 
 
Organized by: Marjorie Davis
Invited Speakers: call contact
 
Deadline for Abstracts: call contact
 
Registration: EVENT INFORMATION
Contact Marjorie Davis, Program Developer, Phone +1.215.442.6176
Fax +1.215.442.6199, email
Marjorie.Davis@diahome.org
E-mail: Marjorie.Davis@diahome.org
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.