Risk Management

• Provide strategic input into risk management and risk minimization approaches
• Partner, support, and advise in your discussions with Regulatory Agencies, in the EU and the US
• Produce regulatory acceptable risk management documents

Additional Risk minimization activities including:

• Patient and healthcare professional communication programs
• Risk Evaluation and Mitigation Strategies (REMS)

Additional Pharmacovigilance Activities (APVA)

• Elements to Assure Safe Use (ETASU)
• Monitoring the effectiveness of risk minimization activities
• Off-label use monitoring