It’s widely reported that the top three stresses in life are death, divorce, and moving. But pharmaceutical or device manufacturers going for product approval might add a close fourth – preparing for high-stakes presentations and meetings like an FDA Advisory Committee meeting. During intense preparations, it’s easy to lose sight of the most important thing – keeping yourself healthy,both physically and mentally. Here are some basic reminders to help you and your team reduce team stress during the ramp-up to a big event.
An FDA Advisory Committee (ADCOM) meeting is arguably the most important day of a product’s life cycle. To prepare for a successful meeting, you’ll need to carefully coordinate many moving parts. The last thing you want, is to forget a seemingly small detail that could derail an otherwise successful FDA Advisory Committee meeting. This is our checklist of high priority (and often forgotten!) steps to make sure your “game day” runs smoothly.
One of the most challenging projects a pharmaceutical or device company ever faces is preparing for an FDA Advisory Committee meeting (ADCOM). This process is a team effort that entails a lot of long days (and nights), constant practice, and never-ending critiques. As a project lead, one of your biggest, and frequently overlooked challenges during FDA Advisory Committee preparation is keeping your team motivated and moving forward. Here are tips to help avoid the pitfall of a shortsighted and apathetic team.
One of the most important rooms at an FDA Advisory Committee (ADCOM) meeting is one that neither the FDA, the Advisory Committee members, nor the public ever see. It’s typically called the “War Room,” and it’s where Sponsors locate data or conduct analyses for Advisory Committee members’ impromptu requests. While some companies overlook the importance of the War Room at their ADCOM, the best prepared ones know it is a critical component of Advisory Committee meeting preparation.