Handbook

Medical Affairs is an emerging specialisation within the pharmaceutical industry which is responsible for managing key opinion-leader relationships, publishing data from corporate-sponsored trials, presenting educational information about a product or therapeutic landscape, answering questions from healthcare providers regarding product safety or efficacy that is not addressed in a product’s label and supporting research initiatives outside labeled indications for marketed products. This course will cover the international and local ethical, legal and marketing codes of compliance, quality use of medicines as well as the writing and interpretation of key scientific documents such as product information, consumer medicine information and clinical trial results. Off-label use of medicines and access to unlicensed products will be covered.  Product withdrawals will also be discussed. Medical Governance principles and strategic alignment with business goals, development of Medical Affairs plans, understanding Advisory Boards’ objectives, development of local medical research initiatives and how to develop a local publication strategy will be covered in the course.