PHARMA & HEALTHCARE / PHARMACOVIGILANCE
Basic knowledge of pharmacovigilance
You will build up basic knowledge of pharmacovigilance obligations and understand which responsibilities are relevant to you. The regulatory bases, important definitions and tasks of drug safety are developed step by step. Learning success checks after each module enable you to track the progress at any time and to present it for audits and inspections.
Module 1: Life cycle of a drug
Module 2: Why is it actually drug safety?
Module 3: Important definitions in pharmacovigilance
Module 4: Legal bases and important authorities
Module 5: Legal Obligations of the Marketing Authorization Holder
Module 6: Obligations of the employees of a pharmaceutical company
Module 7: Consequences and liability in the event of non-fulfillment of obligations