U.S. FDA Projects

New Reviewers Blended Learning Program

The Concerted Solutions team lead the instructional design and development of this engaging learning program that blends six online learning modules, three interactive workshops, and a collaborative online portal. The program teaches the drug review process to new reviewers in the Center for Drug Evaluation & Research (CDER). The extensive program supports the new reviewers over their first 4 – 6 months on the job and serves as a resource throughout their career.

Center for Drug Evaluation & Research Professional Competencies

Concerted Solutions supported CDER’s Division of Training & Development in establishing core competencies for all CDER professionals. In addition, our process developed position-specific competencies for over 60 positions and provided a skills gap analysis for competencies within each position.

CDER Scientific Presentations Skills Learning Program

This 3.5 day learning program consists of 6 half-day seminars spread over four weeks. Especially designed for FDA scientists, it guides them through a five-step process to develop and deliver powerful presentations that connect with their audience. This program follows the design of our Powerful Presentations course, but goes into greater detail and guides the participants as they create a presentation that they present to their peers at the close of the program.

Office of New Drug Career Development Workgroups

The Concerted Solutions teams designed and facilitated a program within CDER’s Office of New Drugs (OND) to create career development resources for OND professionals. A workgroup was formed for each of three professions: clinical reviewer, pharmacological/toxicological reviewer, and regulatory project managers.  Each group then identified key career development areas  and tasks and the resources needed to support them.  These were then published on the OND Intranet to support the staff.