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Drug development and FDA Regulations
This course provides an overview of the drug development process, including GLP, GCP, and GMP processes. It was intended for early stage investigators from varies disciplines with a need to develop and understanding of the drug development process. Participants may be accredited by the American Council on Pharmaceutical Education (ACPE).

Translating Science into Innovation in Healthcare
This course provides an overview to faculty scientists and doctoral trainees in health care disciplines on how to translate knowledge into innovative opportunities to deliver improved care, better outcomes and lower costs. It will cover the fundamental economics of global health care and the growing confrontation between rising expectations and increasingly constrained resources, and describe the opportunities and challenges that face us. Presentations are offered by a faculty of scientists, physicians, health economists, industry analysts, entrepreneurs, venture capitalists, and executives from payers, service companies and drug firms.

Translating Novel Scientific Concepts into Innovative Products in Health Care: Focus on Innovation
This course will follow the science behind drug and device development from discovery to regulatory approval, including clinical trial designs currently in use in Industry to determine if a product is safe and effective and the opportunities for innovation in the existing processes. The course focuses on the needs of young investigators but other interested will be welcome. Those considering working with industry, or in industry, will gain invaluable insights into the field from experts, many of whom began their careers in an academic setting and then moved to conduct research in industry.

Medical Device Good Clinical Practice
This course provides information across the full range of medical device clinical trial activities as an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.

Write Winning NIH Grants
This daylong seminar comprehensively addresses: idea development; proven strategies for successful proposal; practical and conceptual aspects of the proposal-writing process; and finding funding agencies of greatest interest.

Write Winning Career Development Awards
This half-day seminar comprehensively addresses: Career Development Awards (CDAs) including NIH K-Awards, T32, and F32 National Research Service Awards; proven strategies for a successful proposal; candidate and mentor partnering principles/fundamentals for any agency's CDAs.

Writing for Biomedical Publications
Included in this comprehensive seminar is everything from tips and strategies on composing the manuscript, through choosing the appropriate journal and understanding its review process, impact factors, acceptance rates and 'turn-around' times to tips, strategies that are related to revision and resubmission and so much more.

Finding and Navigating Mentoring: How to Find an Effective Mentor
Participants will learn how to find effective research mentors through presentations and interactive activities. Guest speakers are available for one-on-one consultation after the presentations. Mentees at all levels are welcome to attend.

Optimizing the Practice of Mentoring: How to be an Effective Mentor
This workshop's objective is to prepare junior and senior faculty to be effective research mentors through presentations by experts in the field of Faculty Mentoring. Mentors and mentees at all different professional levels are welcome to attend. The 2-day format of lectures and small-group facilitated discussions will engage learners through presentations and other interactive activities.

Investigator-Initiated Trials and the Role and Responsibilities of the Investigator
This course provides an overview of: the applicable regulations for Investigator-Initiated Trials (IIT), including the role and responsibilities of the individual investigator who acts as an investigator and a sponsor in conducting the study; a review of the reporting requirements and essential documentation required for these trials and the risks involved; helpful information on what sponsors look for in industry-sponsored clinical trials.

Preparing Investigational New Drug (IND) Submissions
In this course, approved drug labels and summary basis of approvals are used to help students acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including pre-marketing (IND), and marketing (NDA/CTD) applications. Participants also gain experience with tools that help manage timelines and sections needed from contributors.

Write Winning NIH Renewals
This half-day seminar focuses on writing renewal applications, as well as other strategies for maintaining long-term grant support relating to regulatory and practical aspects of medical device clinical research.