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Speaker PaneI: Dr. William Maier, Vice-President, Epidemiology, Drug Safety and Risk Management Dr. Carl de Moor, Vice President Epidemiology, North America Dr. Paula Thompson, Senior Epidemiologist

The last decade has witnessed an increase in the power of national regulatory authorities to require explicit programmes to control and mitigate risks related to the use of new and existing drugs. The impact on the pharmaceutical industry is substantial because these new laws and regulatory powers will require a significant change in the way drugs are developed and supporting research is done prior to the filing of new drugs.

National regulatory agencies in the US and Europe have adopted similar approaches to enacting risk control programmes. In the US, the FDA has developed the concept of Risk Evaluation and Mitigation Strategies (REMS). The European approach requires that a formal risk control plan (called an EU-RMP) be submitted with each new drug approval application at both a pan-European and national level.

This new era of risk control and accountability requires that companies obtain evidence of the likely effectiveness of their proposed risk control programmes prior to the submission of an application for drug marketing. Failure to provide this information is likely to lead to either longer approval times or increased failures during the drug approval process. However, the information on programme effectiveness is relatively easy and inexpensive to obtain prior to submission of a marketing application. As a result, companies can ensure the success of their new medications by conducting this research.

This webinar will discuss the new US REMS guidance and EU-RMP legislation, and what companies need to do in order to prepare for submissions. This will include the design and evaluation of the appropriateness of different risk management programmes and assessment of the feasibility of different types of post-marketing commitments.

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