| Years of Regulatory Affairs Experience:
|
| |
| IND Assembly and Submission: |
|
During Part of the Process |
|
Oversaw the Entire Process |
| |
| FDA Meetings: |
|
Advisory Panel Meetings |
|
Ongoing FDA Contacts (w/Reviewers, CSO etc.) |
|
Pre-IND Meetings |
|
Troubleshooting Meetings |
| |
| BLA/NDA Assembly and Submission: |
|
During Part of the Process |
|
Oversaw the Entire Process |
|
Orphan Drug Designation |
| |
| Promotion: |
|
Promotional Material Review |
|
Interaction with FDA on Promotion |
| |
| FDA Actions: |
|
Warning Letters |
|
483 Citations |
|
Other |
| |
| Manufacturing: |
|
ELA |
|
GMP |
|
Qualification and Validation |
|
Contract Manufacturing Oversight |
| |
| Product safety: |
|
Investigational Products |
|
Marketed Products |
|
US Reporting |
|
International Reporting |
| |
| Audits: |
|
GCP |
|
Manufacturing |
|
Vigilance |
|
|
