Pharmacovigilance Medical Writing
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.A Good Practice Guide Justina Orleans-Lindsay. Element ... REMS Report Data Source Package Insert Medication Guide/ Drug Safety (Pharmacovigilance)/ Regulatory Affairs Communication Plan Drug Safety (Pharmacovigilance)/ Regulatoryanbsp;...
| Title | : | Pharmacovigilance Medical Writing |
| Author | : | Justina Orleans-Lindsay |
| Publisher | : | John Wiley & Sons - 2012-06-22 |
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