Scientific Advice Meetings

Every medicine is considered on a case-by-case basis by competent authorities. This means from time to time, a new medicine in development, needs input from a team of experts from a competent authority to understand if the interpretation of the guidelines applies to the new medicine/concept. The mechanism to achieve this is to request Scientific Advice Meetings (SAM) with your chosen competent authority.
Scientific Advice Meetings (SAM)

To request a meeting, a number of questions need to be written and submitted, followed by a briefing book just prior to the meeting date. JensonR+ regulatory team can offer the right technical and strategic expertise.

We strongly recommend that our clients take the time to prepare the briefing book and questions, and then consider strategies for supporting and defending the questions and justifications submitted. This process ensures that the right questions are submitted, and the company has made the best use of the agency’s time and expertise to inform their development.

Scientific Advice Meetings and Written Advice can be requested at any point in your product lifecycle. The information obtained from such meetings can inform:

  • Early development strategy

  • Initial MAA applications

  • Post approval manufacturing changes

  • Proposed indication extension or changes

  • Legal Status Reclassifications

Here at JensonR+ our team of experts have the experience to facilitate Scientific Advice Meetings to ensure that the response obtained during the meeting is contributes in a positive way to your development understanding.

Our experts are able to:

  • Review your proposed development plan in close collaboration with your project team to understand the challenges of your specific development.

  • Work with your team to increase the understanding of the Scientific Advice process and develop a coherent Scientific Advice briefing book that contains focused questions which will elicit informative feedback from the agencies not just yes/no answers.

  • Coordinate mini-workshops to ensure the team participating in the Scientific Advice Meeting is fully briefed and interact with the agencies in a manner that maximises the information obtained during a meeting.

  • Provide a meeting facilitator to ensure all key issues are discussed in the Scientific Advice Meeting and maximise the information received.

Get in touch with us to find out more