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Adverse Drug Events - Reporting & Regulatory Requirements

 
  July 13, 2015  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
November 5 & 6, 2015


This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues.

Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered.

Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Michael A. Pierro

Specialties: Regulatory, International

Michael A. Pierro is consultant to life sciences industries; building on over 35 years of pharmaceutical-industry experience to provide services in clinical-practice areas of SOPs, study management and monitoring, auditing and site qualification.

Mr. Pierro previously served as Director of Business Development, Consulting and Clinical Training for a large consulting firm. There, he was responsible for the development and implementation of SOPs, specialized training programs and related consulting services. His clients included pharmaceutical and biotechnology firms, CROs, university medical centers and the United States government.

Before this, Mr. Pierro was Director of Global Training for the Global Clinical Quality Assurance Department of Hoechst Marion Roussel (now Aventis). In this role, he directed all GCP, SOP and technical training activities within the company’s Drug Development Center and other sites throughout the world. In his other roles at the company; he served as a Senior CRA, Manager of Phase-IV Clinical Operations, Chairperson of the SOP Steering Committee and GCP Auditor. In addition, Mr. Pierro was involved in several NDA/SNDA preparations, filings and other reports to regulatory agencies. 

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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