|
2025 RAC Workshop
Virtual Event - Webinar Only
Durham, NC 27701
USA
Tuesday, June 03, 2025, 6:00 PM - 8:00 PM EDT
Category: RAC Workshop
This workshop will have live sessions every Tuesday evening, 6 -8 pm, starting June 3, 2025 and running through September 30, 2025; see the confirmation email for all session dates.
The sessions will be REMOTE; held via Zoom.
The Zoom meeting info can be found in the confirmation email received after you register.
|
|
|
PHARM/BIO
|
|
|
|
|
|
2025 Chapter
|
Speaker
|
Topic
|
|
|
|
|
June 3
|
1
|
1 - Intro
|
Maria Oyaski
|
FDA History (create study groups)
|
|
June 10
|
2
|
1 - Intro
|
Kevin Barber
|
Regulatory Authority Meetings
|
|
June 17
|
3
|
1 - Intro
|
Olu Aloba
|
CMC (drugs and biologics)
|
|
June 24
|
4
|
2 - Early development
|
Brenda Faiola
|
Preclinical Development and GLPs
|
|
July 1
|
No presentation; July 4th week.
|
|
July 8
|
5
|
2 - Early development
|
Matthew Barnes
|
Clinical Protocols and Clinical Development Plans
|
|
July 15
|
6
|
2 - Early development
|
David Jensen
|
Good Clinical Practice
|
|
July 22
|
7
|
2 - Early development
|
Judy Hauser
|
Combination Products
|
|
July 29
|
8
|
3 - Regulatory Procedures
|
Karl Whitney
|
INDs, IMPDs, CTAs, & CTXs
|
|
Aug. 5
|
9
|
3 - Regulatory Procedures
|
Sheila Plant
|
NDAs/BLAs, MAAs, JNDAs, NDSs
|
|
Aug. 12
|
10
|
3 - Regulatory Procedures
|
Erin O’Reilly
|
Pediatric, Orphan Product and Expanded Access Development for Rare Diseases
|
|
Aug. 19
|
11
|
4 -Specific product types
|
Catherine Maher
|
Pharmaceuticals, Generics, and OTC Drugs
|
|
Aug. 26
|
12
|
4 -Specific product types
|
Maria Oyaski
|
Biologics and Biosimilars
|
|
Sep. 2
|
13
|
4 -Specific product types
|
Maria Oyaski
|
Advanced Medicinal Therapeutic Products
|
|
Sep. 9
|
14
|
5 – Late development
|
TBD
|
Pharmacovigilance and Risk Management
|
|
Sep. 16
|
15
|
5 – Late development
|
TBD
|
Prescription Product Labeling
|
|
Sep 23
|
16
|
5 – Late development
|
Drew Barlow
|
Compliance, Regulatory Inspections, and Enforcement
|
|
Sep 30
|
17
|
5 – Late development
|
Patricia Termini
|
Post Marketing
|
|
|
|
|
Contact: [email protected]
|
Prev Month
View Month
Search
Go to Month
Next Month
All repeats