| 9:00 - 9:15 am |
Introduction/ Schedule for Day 1 & 2 |
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| |
Day One |
|
| 9:15 - 11:15 |
|
Clinical Trial Overview |
| |
|
- Phases of Drug Development Process
- Types of Clinical Studies
|
| 11:15 - 11:30 |
Break |
|
| 11:30 - 12:30 pm |
|
FDA Regulation (A Brief History in Time) |
| 12:30 - 1:30 |
Lunch |
|
| 1:30 - 3:00 |
|
FDA Regulation Continued... |
| |
|
- Informed Consents and Human Research Protection
- Good Clinical Practice Guidelines and Compliance
|
| 3:00 - 3:15 |
Break |
|
| 3:15 - 5:00 |
|
GCP (cont.) Clinical Protocols |
| |
Day Two |
|
| 9:00 - 11:00 am |
|
Case Report Forms |
| |
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- Concomitant Medications
- Non-Serious and Serious
- Adverse Events/ Investigator
- Brochures, IND's and NDA's
|
| 11:00 - 11:15 |
Break |
|
| 11:15 - 12:30 |
|
Fundamentals of Institutional Review Boards |
| 12:30 - 1:30 |
Lunch |
|
| |
|
|
| 1:30 - 1:45 |
|
Familiarization with Clinical Research Organization (Sponsor/Biotech, Pharmaceutical), CRO, Central Labs |
| 1:45 - 3:00 |
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Definition, Roles, Responsibilities and Interaction of Clinical Research Functional Groups |
| |
|
- Data Management
- Clinical Drug Safety
- Clinical Research Associate
|
| 3:00 - 3:15 |
Break |
|
| |
|
|
| 3:15 - 5:00 |
|
Questions and Answers
Handouts of Common Industry Acronyms & Definitions. |
| This seminar is $995.00 for two days, breakfast and lunch will be provided. |
