Preparing to present and defend your product at a high stakes meeting is a major challenge for any team. At critical lifecycle milestones, such as CHMP Oral Explanations, FDA Advisory Committees or payer negotiations, your product’s future may be at stake. Achieving success in these venues requires a clear strategy and focused preparation. Your company needs to deliver a clear and compelling argument supporting your position, and be ready to respond confidently when challenged.
Our team — communications strategists and coaches, regulatory and HTA experts, and presentation/technology specialists — bring critical skills and expertise to help clients succeed. We understand how to address strategic and data challenges and how to make the complex simple. We excel at helping our clients deliver an argument with impact. We have a passion for helping scientists communicate clearly, confidently and persuasively to give the product the best possible chance for success.
Our Track Record
We have successfully prepared hundreds of client teams for high-stakes interactions with regulatory bodies, payers and assessors, since the late nineties. Our exceptional coaches have improved the communication skills of more than 1,500 healthcare professionals using PharmApprove’s proprietary techniques in small groups, customized large workshops and private coaching sessions. Our experience spans all types of high stake meetings, including Oral Explanations, Advisory Committees, HTA and payer meetings and pre-NDA/BLA meetings. We are now building on our successful track record by helping teams prepare for PRAC Public Hearings.
How we Help
Our team combines a deep understanding of scientific and regulatory audiences and a mastery of communications tools and techniques to prepare clients for key interactions with the FDA, EMA and other authorities worldwide. Our proven approach to preparation along with customized tools and techniques have helped client teams excel in many settings.
We support every element of meeting preparation – strategy, messaging, briefing materials and presentation development, Q&A and presentation skills training. Realistic and predictive mock panel sessions are a highlight of the process, with panel members drawn from our Advisory Board and network of over 1,000 experts. Our mock panels provide candid and actionable feedback to help teams strengthen materials and communication skills.
The outcome: your team will be 100% prepared for your high stakes meeting.