Pharmacovigilance Medical Writing Orleans-Lindsay Justina
Pharmacovigilance Medical Writing Orleans-Lindsay Justina Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e.…
Specifikacia Pharmacovigilance Medical Writing Orleans-Lindsay Justina
Pharmacovigilance Medical Writing Orleans-Lindsay Justina
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. 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. from clinical development through to applications for marketing authorisations to the post-marketing stage).
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.