Eu2P

Description

Objectives: To enable participants (specialists) to develop an understanding of the requirements of the Pharmaceutical Industry’s operational aspects of pharmacovigilance as it relates to the preparation and assessment 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. Topics covered: Case reporting Periodic reporting Product Labelling and Risk Management Plans Contractual arrangements

Methodology

IMI Standards

• A predefined set of teaching objectives, leading to defined learning outcomes
• Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
• A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
• Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
• Defined and transparent admission criteria
• Quality assurance of teaching staff
• Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
• The facilities, infrastructure, leadership and competences available for the support of student learning
• University accreditation OR a system for approving, monitoring and reviewing the training offered