Pharmacovigilance (German translation: Pharmakovigilanz) is a system for monitoring and controlling the safety and efficacy of drugs after their market launch. Pharmacovigilance comprises monitoring adverse drug reactions (side effects and interactions) as well as the evaluation and analysis of the data obtained in order to take action if necessary.

The most important aspects of pharmacovigilance include:

• Monitoring adverse effects (translation into German: unerwünschte Arzneimittelwirkungen): Pharmacovigilance involves monitoring and documenting side effects and interactions of drugs by patients, healthcare providers and other sources.
• Data collection: Organizations that manufacture drugs are obligated to collect and analyze data on side effects in order to determine whether there are new or unexpected side effects.
• Data analysis: The collected data is analyzed to identify patterns and trends in adverse effects. This can also include the identification of certain risk groups or characteristics.
• Reaction to data: If new or serious adverse effects are identified, the manufacturing company is obliged to take measures. This may include a change in product labelling, a change in dosage (German: Dosierung) or even a recall of the product from the market.
• Reporting: Manufacturers must inform the regulatory authorities and other groups with a vested interest of any adverse effects and subsequent measures taken.
• Compliance with regulations: Pharmacovigilance must be in accordance with regulatory and legal requirements.

Pharmacovigilance plays an important role in ensuring the safety of drugs once they have been brought onto the market. It helps to ensure that adverse effects that may occur under the actual conditions of use are recognized and responded to. Pharmacovigilance also ensures continuous improvement of the safety and quality of drugs.

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