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BASIC PHARMACOVIGILANCE AND PHARMACOVIGILANCE REGULATIONS


Eu2P Certificate: Basic Pharmacovigilance and Pharmacovigilance Regulations

OBJECTIVES

The objective of this module is to provide you knowledge and understanding of the concepts and principles in pharmacovigilance in North America such as

  1. The requirements for Pharmacovigilance in the United States as compared to the ones in the European Union, for Pre-approval and Post-approval and the imminent changes in the European Union and in the United States
  2. The legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice
  3. The safety communication processes and the safety risk management approach, including the safety label change process
  4. The principles of prescription drug labeling in the United States, the FDA requirements for prescribed drug labels and the United States Prescribing Information (USPI)
  5. The analysis of the safety profile of any medicine which should weight up the consequences of a given adverse drug reaction to individual patients exposed to the medicine, as well as the impact on the community

concepts, principles, pharmacovigilance, USA, FDA, legal framework, USPI, QPPV, pre-approval, post-approval

 

MODULE PARTS

  1. Pharmacovigilance Regulations
  2. Labeling and Combination Products
  3. Adverse Drug Reporting

 

TRAINER TEAM

Coordinator: Dr Veronique Kugener (from Takeda)

Expert(s): Prof Albert Figueras (from World Health Organization), Dr Sherael Webley (from University of Hertfordshire), Dr Marina Malikova (from Boston University School of Medicine), Dr John Price (Independent), Dr Maribel Salas (from Daiichi-Sankyo), Dr Abimbola Cole (from Takeda), Nasop Experts Group (from ISoP's North American chapter).

Introductory level
75 h workload over 3 months (3 ECTS credits)
Key dates
Course calendar
Certificate award
or included in PhD programme
English language
Online based learning
Student :
1,500 € / $1,750
Professional :
3,000 € / $3,500
  Savings could be offered under eligibility conditions.

APPLY NOW

Applications open until December 12th, 2021

Or include this module in your training curriculum choices...

PhD



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