Recommended sources of further information

While PASS is being planned and conducted, it is recommended by SÚKL to follow the principles of Good vigilance practices (GVP) Module VIII as well as principles of Good epidemiological practices issued by epidemiology and pharmacoepidemiology societies and scientific bodies. These principles can be found here:

• https://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/documen t_listing_000345.jsp&mid=WC0b01ac058058f32c#section5 (GVP)
• COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 (Commission Implementing Regulation No.520/2012)
• https://www.encepp.eu/standards_and_guidances/index.shtml
• https://www.pharmacoepi.org/
• https://www.epiresearch.org/index.php
• https://www.cioms.ch/
• STROBE statement: https://www.strobe-statement.org/index.php?id=available-checklists
• PRISMA statement: https://www.prisma-statement.org/statement.htm