• Identify and apply key message for both US and European approvals
• Prepare and edit critical submission documents
• Develop comprehensive databases of questions and answers
• Advise on Risk Minimization Action Plan (RiskMAP) strategy and development
• Prepare and sharpen oral and visual presentations

• Create Advisory Committee member profiles (print and video)
• Create FDA staff profiles (print and video)
• Identify and analyze core issues
• Research and analyze potential opposition

• Provide presenters with intensive, individualized speaker training
• Provide team with rigorous Q&A training
• Produce and supervise mock Advisory Committees and rehearsals
• Identify and recruit therapeutic experts as panelists and advisors
• Provide comprehensive onsite services for actual hearings

• Provide regular "refresher" courses in speaker, Q&A techniques
• Conduct workshops on FDA and EMEA procedures and best practices
• Create and produce team development programs (seminars and workshops)
• Provide ongoing advice and counsel to senior management

PharmApprove is a division of Taft and Partners, an integrated communications firm who specializes in producing customized workshops across a variety of industries. Taft also has special practice areas in marketing, branding, leadership development, digital and new media, video and events, and public relations. To learn more about Taft, click here.