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Business Case and Issues

Safety Surveillance and Risk Management

business case and issues - ibr ag
Typical reasons to carry out post approval safety surveillances are:
    • Collection of additional safety information to confirm and refine safety profile
    • Products where rare but severe adverse reactions cannot be ruled out
    • Monitoring of the drug as used in real life (day to day medical practice)
    • Prevention of use in contra-indication situation (e.g. use during pregnancy, off-label use, comedication)
    • Products for which truest of authorities, prescribers and patients has to be established, enhanced or re-established.
    • Biogenerics

A phase IV study / surveillance can fulfill the following objectives:

    • Increase of risk awareness by the prescriber (e.g. liver values, immunogenicity)
    • Increase compliance with monitoring requirements as per Specific Product Characteristics (SPC)
    • Early detection of safety signals
    • Motivate the prescriber to report adverse events to underline the safety profile
  

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Many Post Marketing Safety Surveillances can be set up as non-interventional surveillances and therefore do not fall under the

European Clinical Trial Directive (2001/20/EC). This allows for more freedom in clinical trial design, increasing acceptance by the
prescribers and facilitating operation by the sponsor. Good EDC technology will allow maintain data quality.

Risk management programs should be drafted before filing a new drug for regulatory approval. A good risk management
program will accelerate the approval process. Additionally, it gives a competitive advantage by reducing prescribers' safety
concerns and increasing the visibility of the product.

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