Pharma Journals Pharmacovigilance

The relationship between the pharmaceutical industry and government is an important determinant of the government approach to managing pharmaceuticals at the national and EU level. New Pharmacovigilance legislation has some major achievements: clarification of roles and responsibilities of various stakeholders, strengthening of the risk-adjusted approach, improvement of transparency, strengthening and clarification of procedures in relation to the use of PASS and RMP, involvement of patients. Nathalia Valkova, Role of regulatory affairs in pharmacovigilance: Marketing authorizations and new pharmacovigilance legislation in EU: Important changes, challenges and options.

• Share this page
• 
• 
• 
• 
• 
• 

Last date updated on September, 2024