collapse allexpand all
Regulatory Science (RSCI)
Introduction to regulatory environments surrounding medical product development, manufacturing and marketing; operation of federal, state and international regulatory bodies.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49111D | 626 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE & ONLINE |  |
Development and testing of new medical products according to U.S. and international regulatory requirements.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49113D | 626 | Lecture | TBA | TBA | 0 of 50 | Susan Bain,Eunjoo Pacifici | OFFICE & ONLINE | |
Legal issues affecting intellectual property, medical product development, marketing and safety, taught through case studies and lectures.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49102D | 626 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE & ONLINE | |
Development and execution of clinical trials: bioethical principles, good clinical practices, project management and documentation.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49103D | 626 | Lecture | TBA | TBA | 0 of 50 | Tony Succar, Nancy Pire-Smerkanich,Terry Church,Eunjoo Pacifici | OFFICE & ONLINE | |
Developing form and content for investigational drug applications, new drug applications, biologic licensing applications to FDA; common technical documents; considerations of writing style.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49105D | 626 | Lecture | TBA | TBA | 0 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici | OFFICE & ONLINE | |
Provides a firm foundation in the domestic and international CMC process, from concept to commercialization of new active pharmaceutical ingredients and products.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 48201D | 626 | Lecture | TBA | TBA | 0 of 50 | Roger Clemens,Eunjoo Pacifici | OFFICE & ONLINE | |
Research/policy analysis conducted under preceptor supervision in an industrial or governmental setting.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 48204D | 626 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici | OFFICE | |