This course intends to give you an overview of the Guidelines for Good Pharmacoepidemiology Practices by providing you with 

• A description of the protocol for pharmacoepidemiologic research
• An overview of the origin and key elements of the most relevant guidance for good pharmacoepidemiology practice
• An overview of the guidelines for good pharmacoepidemiology practice in regards to responsibilities, personnel, facilities, resource commitment, and contractors
• An overview of the principles of human data protection and key aspects of data collection, management, and verification in pharmacoepidemiologic studies
• Guidelines for analysis and reporting of pharmacoepidemiologic research
• An overview of the key guidance on best practice in the communication and dissemination of information about pharmacoepidemiology studies
• An overview of the guidelines on adverse drug events reporting and archiving practices in pharmacoepidemiologic studies

By the end of the training you will be able to :

• Access the tools that are available to support good practice in the area of pharmacoepidemiology

• Identify the need for a protocol, the elements of a protocol, and tools to check the completeness and quality of a protocol and access examples in the EU PAS® Register

• Become familiar with aspects relating to responsibilities, personnel, facilities, resource commitment, and contractors and the data protection regulations and ethics requirements and data collection principles in pharmacoepidemiologic studies

• Understand the rationale for and key components of a statistical analysis plan

• Plan and implement efficient and effective communication and dissemination of information about pharmacoepidemiology studies

• Become familiar with the key concepts and the requirements regarding reporting adverse events related to drugs as well as the guidance for archiving of study materials