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Pharmacovigilance

 
  March 06, 2014  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ
July 10-11, 2014


Who Should Attend
This course is designed for a broad range of clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical companies. It will be of special value to executives and managers in charge of:

  • Pharmacovigilance
  • Medical affairs
  • Clinical research
  • Data management
  • Regulatory affairs
  • Risk management and drug discovery
  • Preclinical R&D
  • Drug safety from pharmaceutical giants doing business in China

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Description
This intensive, 2-day course provides a comprehensive explanation of the pharmacovigilance practices for drugs and biologics including guidance on characterization and classification of adverse drug reactions, pharmacovigilance plan development, benefit/risk assessments, and actions following the assessment.

Emphasis will be placed on how pharmacovigilance is integrated into the multidisciplinary development plans of new drugs and biologics, and how it affects development decisions. Regulatory affairs will be covered, and descriptions given of the European and the U.S. FDA requirements, the postmarketing risk assessment process, and common regulatory errors.

The goal of this course is to give a working knowledge of the principles of pharmacovigilance, its regulations and proactive strategies for meeting regulatory requirements and for drug safety risk management.

 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers: Dr. Shayne C. Gad; Principal of Gad Consulting Services

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, an twenty-two year old consulting firm with six employees and more than 500 clients in the US and overseas. Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson, as a manager of the toxicology lab at Allied Signal, and at the Chemical Hygiene Fellowship at Carnegie Mellon Institute.

Dr. Gad has published 45 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and medical device development and safety assessment. He has previously served as a Counselor and President for ACT, as President of three SOT specialty sections and of the Roundtable of Toxicology Consultants, as a reviewer for NIH, and editor of two journals. He has also conducted the triennial salary survey for toxicologists. He has more than 37 years of broad based experience in these fields and has successfully filed more than 100 INDs and 27 - 510(k)s.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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