As part of the Bionical Emas series ‘4 things to think about’, Rebecca Applin outlines key areas that those involved in the medical review and approval of promotional materials should consider.
1. Early medical input
Early medical input can really help to promote efficiency in the review cycle of materials. In particular large or complex items or activities such as company websites, meetings and educational services, benefit from early discussions at the planning stage to avoid unnecessary and time-consuming additional review cycles. Early input ideally is at the point of the brief preparation. A thorough understanding of the objective of the material by the full approval team can help to ensure comments and changes on materials are relevant and helpful, but also can identify any compliance issues right at the start.
In the era of electronic approval systems and remote working the value of verbal and face to face communication can often be forgotten. But in the development and review of materials their value should not be underestimated. Poor communication can have a deleterious impact on the approval time and even the quality of materials. A short teleconference provides the opportunity to explain reasoning, understand points of view and resolve issues in a much shorter space of time than multiple rounds of comments.
3. Building relationships
Developing a good working relationship with the client is essential for an external medical team. Understanding how each other works and setting expectations, both from a process perspective and on the less tangible aspects of working together should be high on the list of priorities when starting out. Setting-up an initial face to face meeting, taking time to discuss points of view on early activities and materials will help to build that understanding and set the team off to a good start.
In this dynamic environment, maintaining expertise to support and advise clients on compliance is essential. Training, sharing experience and reviewing cases to obtain as broad knowledge as possible are all part of developing and maintaining up to date knowledge and expertise.
About the Author
Rebecca Applin is a Senior Project Manager with many years experience in the area of medical information, promotional materials, disease awareness campaigns and pre-license activities.
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