Tufts CSDD offers a variety of custom on-site and virtual Drug Development Training Courses covering fundamental areas of drug development and regulatory science, and hot topics on issues, challenges, new practices, and solutions. Programs are customized to the specific needs of individual organizations. Below is a list of topics from which to choose and design your program. Tufts CSDD can also work with you to add topics not listed below. Once you have selected topics of interest, Tufts CSDD will prepare a proposal and budget and will identify and engage faculty:

Series A: Fundamentals of Drug Development

1.  Overview of Pharmaceutical R&D
2.  The Discovery and Preclinical Process
3.  Translational Medicine — Discovery to Development
4.  Principles of Clinical Pharmacology
5.  Pharmacogenomics and Its Role in Drug Development
6.  Overview of Clinical Trial Designs
7.  Adaptive and Master Protocol Designs
8.  Biostatistics and the Role of Randomization in Clinical Trials
9.  Global Regulatory Science — Generating Evidence for Regulatory               Approval
10.  Development of Personalized Medicines

Series B: Focus on Drug Development Operations and Performance

1.  Managing Protocol Design Elements to Optimize Clinical Trial Performance
2.  Patient Recruitment and Retention
3.  CMC/Clinical Supplies and Quality Management in Drug Development
4.  Pharmacovigilance, Post-Marketing Surveillance, and Risk Management
5.  CRO, Vendor, and Investigative Site Qualification Assessment and Management
6.  Data Management Strategies and Practices
7.  The Patient Engagement Movement — Leveraging Patient Centric Solutions
8.   Development Workforce Digital Transformation
9.  Best Practices in Team Leadership Techniques
10.  Adopting and Managing Innovations Supporting Clinical Trial Execution
11.  The Next Translational Block — from Clinical Research to Clinical Care
For more information about designing a custom virtual or on-site program:
Please contact Sundé W. Daniels at sunde.daniels@tufts.edu