Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Preparation of a meaningful and appropriate risk management plan a multifunctional task ***

Susanne Junker, geb. Weber (Abschlußjahr: 2011)

Language: English

Every effective medicine is associated with risks. Risk detection, risk assessment, risk minimisation and risk communication are the core elements of risk management. At the time of approval merely limited data are available on the safety of a medicinal product because clinical trials due to their limitations do not present “real-world use” experience. It is therefore essential that post-authorisation data are used as a supplement to the data generated during the clinical development phase in evaluating the safety aspects of a medicinal product. The EU-Risk Management Plan constitutes a proactive approach to detect and assess risks with the objective to reduce risks by means of risk minimisation activities including adequate risk communication.

The preparation of an EU-RMP has become mandatory for new medicinal products in 2005 with the introduction of the “Guideline on Risk Management Systems for Medicinal Products for Human Use” a European legislation that authorises regulatory authorities to require pharmaceutical companies to submit an EU-RMP. The content of the EU-RMP is regulated in the template of this guideline.

Risk management is handled differently from country to country. Not every authority requires a formal risk management plan. Other regulated countries like the United States, Japan and Australia have established risk management systems as well which illustrates the increasing importance of the introduction of risk management and specifically risk minimisation activities. In most countries, however, the applicant/MAH does not have to follow a fixed structure for the risk management plan as is the case in the European Union for the preparation of an EU-RMP.

The broad purpose of the EU-RMP is to make sure that all risks are actively managed with the aim to protect patients from serious adverse reactions. The core aspect of the preparation of a meaningful and appropriate EU-RMP consists of the effective and aligned cooperation of the involved departments. A thorough planning will lead to an on-time finalisation and submission of the EU-RMP and avoid any delay. To coordinate this multifunctional task successfully, an RMP officer should be nominated and provided with adequate authority. A good time management and a well-prepared and sound EU-RMP can lead to a faster assessment by the regulatory authority and will potentially accelerate the overall approval process.

Pages: 44