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Drug Safety and Pharmacovigilance: A Comprehensive Course

 
  December 10, 2018  
     
 
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
25-27 March 2019


Who Should Attend?
This course is designed for professionals in the Pharmaceutical, Biotechnology, and related industries who work in the range of first in human clinical trials through and including post-marketing. It will be especially beneficial to individuals in the following areas:

  • Drug Safety/Pharmacovigilance (entry level to manager)
  • Clinical Operations (entry level to manager)
  • Quality Assurance (entry level to manager)
  • Regulatory Affairs (entry level to manager)
  • Computer System Validation (entry level to manager)
  • Management (director level and above)

Course Description
Drug safety/Pharmacovigilance is an integral component of pharmaceutical development that spans from first in human through all stages of clinical development, continuing through and including marketing. This 3-day accredited, intensive course will outline the history of Drug Safety and Pharmacovigilance, the difference between the two, include steps to establish a robust and fully functional drug safety/pharmacovigilance department, including interfaces with other departments.

Discussions will include: A-Z scalable model for growth potential, establishment of a safety database, what questions to ask when evaluating company needs, how to interact with other departments, Health Authority interactions, regulatory interactions, filing the IND, authoring CSRs, filing the NDA, and post-market studies and data collection. 

Bring your roadblocks and your questions. This course encourages open discussions and interaction.
 
 
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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