A Pharmacovigilance (PV) Plan is a description of the routine pharmacovigilance activities and of the additional actions for products with important identified risks, important potential risks, or important missing information. The purpose is to document the activities for detection, assessment, understanding, and prevention of adverse effects or any other drug related problems.
The PV Plan, which is based on the principles of the ICH E2E guideline, contains the safety specification with elements and summary of the important identified risks, important potential risks, and important missing information; the pharmacovigilance plan; and the pharmacovigilance methods.
The PV Plan is submitted to the US FDA when required and can be updated when important information on safety becomes available and milestones are reached.
Writing the PV Plan is a team effort involving many functions. It is developed based on several source documents, including but not limited to the nonclinical and clinical overviews and summaries and the PSUR/PBRER (for marketed products). It should provide an integrated overview/discussion focusing on the most important risks that have been identified or are anticipated based on preclinical, clinical and post-marketing data.
The Emtex Medical Writers can help you with the document development process (eg, writing sections and coordinating the review and consolidation of comments). Furthermore, the Emtex Medical Writer can play a critical role in ensuring that all contributions from the involved functions are provided and reviewed in a timely manner and that the data presented is in line with the information contained in other documents.