maintenance e.g., Renewals Pharmacovigilance e.g., LRMP Labelling and Artwork Management Robust Health Authority updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments within agreed timelines. Labelling & Artwork Management: Ensure labelling and artworks are effectively effectively managed through the company, Global Labelling Business Process. Co-ordinate the operations of Gazelle Accuracy of content of documentation submitted. Recording of risks in dossier at the time of submission
maintenance e.g., Renewals Pharmacovigilance e.g., LRMP Labelling and Artwork Management Robust Health Authority updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments within agreed timelines. Labelling & Artwork Management: Ensure labelling and artworks are effectively effectively managed through the company, Global Labelling Business Process. Co-ordinate the operations of Gazelle Accuracy of content of documentation submitted. Recording of risks in dossier at the time of submission