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Non-Clinical Drug Safety Evaluation and Drug Development

 
  December 10, 2018  
     
 
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
20-22 March 2019


Who Should Attend?
This course is designed for a broad range of pre-clinical, clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical and biological companies. 

It will be of special value to:
  • Scientists who wish to gain an understanding of pharmaceutical
     toxicity studies
  • Safety professionals
  • Regulatory personnel
  • Managerial personnel
  • Early clinical project management staff
  • Regulatory scientist involved in preclinical development
  • Investors
  • Anyone interested in preclinical toxicology studies

Course Description
This 3-day intensive, accredited course offers a thorough dive into non-clinical development of drugs and biologics, including pharmaceutical toxicology and product safety assessment. Upon completion of this course, participants will have an understanding of the relationship between pharmacology, clinical trial design, how to build the safety profile, project management, and regulatory strategy. Tools will be provided to utilize EMA, FDA, and Health Canada regulations for new drug review process. The importance of toxicology study integration into development plans of new drugs and biologics and the impact of development decisions will be a pivotal part of this course. The goal of this training is to provide the framework for working knowledge of where pharmaceutical toxicology and drug development meet to streamline efficient compound trials. This is an interactive course, so bring all of your questions and scenarios. 
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Michelleanne Bradley, President, Metis Consulting Services Inc.

Michelleanne Bradley is President of Metis Consulting Services Inc. She has over 15 years of experience in the Biotech and Pharmaceutical Industries. Ms Bradley has started drug safety departments for small organizations, acquisition integration for midsized organizations, and implementation with large organizations. 

Ms Bradley is currently a pharmacovigilance and quality assurance consultant, performing site, company, and vendor audits, gap analysis, and oversight of drug safety database implementation. She has extensive experience with FDA and EMA audits and is a named consultant with a testing lab in the San Diego area. She is a graduate of the University of Georgia, Athens GA.

 


 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
   
 
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