Module 1:  Principles of Pharmacovigilance
The purpose of Module 1 is to give the participants an understanding of the basic principles of pharmacovigilance. The participants will obtain knowledge of how to analyse and evaluate methods and data in drug safety reporting as well as analyzing and evaluating relevant regulations and guidelines in pharmacovigilance and pharmacovigilance systems.  Risk Management Plans, Post-Authorisation Safety Studies and requirements for Periodic Safety Update Reports will also be covered.
7-9 Februar 2011

Module 2:  Pharmacovigilance Systems – a hands-on approach
Module 2 will help the participants to better understand the basic principles of pharmacovigilance systems, including the structure and organization of the pharmacovigilance department, its interfaces with other departments and the standard operational procedures in a pharmacovigilance department. The participants will gain knowledge of the role of the QP, the role of literature surveillance, how to use and access databases and electronic submission of safety data, MedDRA, use of best practices in drug safety reporting including relevant SOPs, prepare PSURs, prepare and follow up on audits and inspections by authorities and operate in a highly dynamic and constantly changing environment.
26-28 September 2011

Module 3: Pharmacoepidemiology
During Module 3 the participants will get an introduction to pharmacoepidemiology and epidemiological measures of frequency and risk as well as to cohort studies, case control studies, data sources, studies of drug use and sources of error in pharmacoepidemiological studies and how to deal with them. Framing of pharmacoepidemiology in pharmacovigilance, spontaneous reporting of adverse drug reactions and a number of currents controversies are also covered.
TBD

Module 4: Post-marketing Surveillance
The aim of Module 4 is to make the participants able to understand what constitutes post-marketing surveillance, including the definition and scope of post-marketing surveillance, risk management plans, post authorisation safety studies, types of studies, post-marketing spontaneous reporting, signal detection, tools for signal detection, interpretation of findings, actions following a confirmed signal, SPC update, crisis management, execution of recalls and product life cycle management.
4-6 October 2010

Module 5: Preclinical and clinical aspects of pharmacovigilance
This module provides the participants with a good understanding of what constitutes preclinical safety studies and safe dose selection for first human trial, phase I studies, decisions for first in man, decisions for safety margins and first dose in man, regulatory requirements, preclinical ADME, principles of safety in phase II studies, principles of phase III studies and regulations for safety assessment.
TBD

Module 6: Pharmacovigilance data in Application and Registration
The purpose of Module 6 is to give the participants an understanding of how pharmacovigilance and safety data is used in applications and registration. Risk Management plans, clinical summaries and overview, annual safety reports and integrated clinical study report will be covered, as well as the authority perspective on paediatrics, centralized procedure and applications for new medicinal products.
5-6 April 2011

Module 7: Adverse Drug Reactions by Body Systems
Module 7 will provide an exhaustive survey of drug induced adverse reactions in body systems, of pharmacokinetics and pharmacodynamics with focus on adverse drug reactions and classifications of adverse drug reactions.
23-25 May 2011