Objectives: To enable trainees to develop an understanding of European, USA and major local and worldwide regulations and guidelines concerning pharmacovigilance. Emphasis will be placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-marketing.
Objectives: To understand the role of medicines in therapeutics, health services and society; To become familiar with the life cycle of medicines and the regulatory aspects of medicines market; To review the clinical and pharmacological basis of prescribing; To understand the need to evaluate the effects of medicines from an epidemiological perspective; To understand the relevance of unbiased information to ensure the appropriate use of medicines;To discuss the need to monitor medicines prescribing process
Objectives: To gain insight into different preference valuation techniques and (pharmaco)economic evaluation methods. This module will address valuation of health states and pharmacoeconomic evaluation methods. Economic consideration play an important role in decision-making on medicines, e.g. for reimbursement purposes.
Medicines are among the most regulated products in society. From the earliest pre-clinical stages onward, policy makers want to foster the development of safe, effective and affordable medicines for patients in need of pharmacotherapy.
Objectives: To understand applications of probability in statistics; To understand how to organize and describe epidemiological data; To understand how to perform data estimations, comparisons and predictions; To understand how to estimate the sample size and power of epidemiology studies; To introduce the principles of multivariable comparisons.
Objectives; To know the basic principles of communication and to gain an insight into the characteristics of effective communication. To face to the complexity communication on risk for health. To know the evolution of medicine risk communication.
Objectives: To become familiar with the different tools that could be used in pharmacovigilance and pharmacoepidemiology research implementation; To become familiar with the principles of scientific communication
Objectives: To understand the basic concepts and principles in epidemiology; To become familiar with the epidemiological tools that could be used in pharmacovigilance and pharmacoepidemiology; To understand the specificity of epidemiological tools applied to pharmacovigilance and pharmacoepidemiology.
Objectives: To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-marketing environment and the roles of various stakeholders within pharmacovigilance.
Objectives: To understand how to evaluate the effects of medicines and therapeutic interventions both during drug development and clinical use. To know the main methodological and ethical characteristics and limitations of randomized clinical trials.
The course will cover key issues in pharmacoepidemiologic and drug safety research. Special topics include databases and molecular pharmacoepidemiology.
Objectives: To enable participants (specialists) to develop an understanding of the requirements of Pharmaceutical Industry of the operational aspects of pharmacovigilance as it relates to the preparation of documents legally required by regulatory bodies. Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.