Author: Stacey Homan
If you don’t have the time to sit through a webinar (they are about an hour), here are five short and sweet practical basics I learned while going through the creation and management of a cross-functional promotional review committee (PRC):
- Put the correct people in the room. You don’t need every senior executive in your company to have final approval; keep it to a minimum to ensure a thorough review with a quick sign-off. However, make sure you have the final decision makers–the ones with the power to make the right judgment calls on risk and appropriateness. Marketing, Regulatory/Clinical affairs and Corporate Compliance should have a seat at the table, plus legal if you have in-house counsel. The more people that need to be present, the more time documents take to get obtain approval from everyone in the room.
- Dedicate a weekly meeting time. Have your committee set aside a dedicated weekly appointment for the review, editing and approval of documents (the amount of time will depend on the amount of materials needing approved). The committee should meet in person to discuss all documents. This ensures that if someone has a concern regarding a specific document, it can be discussed and resolved while everyone is together, saving valuable time and avoiding potential miscommunication.
- Paper approval works better than electronic. I’m a Millennial, so it pains me (PAINS ME!) to say that the paper signature process works better than an electronic system. Collateral and its accompanying final approval by paper signature during the weekly meeting can be uploaded into an electronic system, e.g. MasterControl, for record keeping. I once tried an entirely electronic approval system, where individuals could log in to review documents, request corrections and approve, but it was difficult for senior executives to remember to log in to approve documents.
- Training, Training, Training. Individuals who have approval privileges should be highly trained in the laws, interpretations and enforcement trends surrounding promotional activities across geographies with an emphasis on their functional expertise in the meetings. The meeting is not a place to be reading FDA guidance documents for the first time. By the time a document enters the PRC approval process, it should have ALREADY been reviewed by Marketing to ensure proper branding, copyright permissions, grammar and spelling.
- Be Inclusive/Communicate Broadly. All company employees should be well versed in your internal procedures, and internal guidelines should be set up for the possibility of rogue employees breaking out on their own. What happens if a random employee answers questions on Facebook or another message board? If a sales rep distributes content without a physician’s request? If an engineer bypasses the system to give a presentation to a customer? These concerns should be addresses through your PRC and possibly HR.
I’m interested to hear the challenges our readers have encountered in creating a PRC for their organizations, as well as success stories or tips from which others can learn.