Seminar schedule for the two-day seminar
Day 1 (8:30 AM to 4:30 PM)
- For most locations, breakfast will be served in the meeting room. For the Hotel Indigo, we will meet in the hotel's restaurant, where a hot breakfast will be provided before we go to the hotel's meeting room for the seminar.
- There will be a break mid-morning, with snacks, beverages and coffee provided in the meeting room.
- Lunch will be provided in the meeting room (most locations) or the hotel restaurant (Hotel Indigo).
- There will be a break mid-afternoon, with snacks, beverages and coffee provided in the meeting room.
- Dinner will be on your own. At the Hotel Indigo, the hotel restaurant and bar will be open for serving dinners and drinks, and there are several boutique restaurants in town, several blocks away. At the Gaylord Resort, there are several restaurants located inside the atrium area.
Day 2 (8:30 AM to ~2:00 PM)
- For most locations, breakfast will be served in the meeting room. For the Hotel Indigo, we will meet in the hotel's restaurant, where a hot breakfast will be provided before we go to the hotel's meeting room for the seminar.
- There will be a break mid-morning, with snacks, beverages and coffee provided in the meeting room.
- Lunch will be provided in the meeting room (most locations) or the hotel restaurant (Hotel Indigo).
- The seminar will adjurn around 2 or 3 PM, depending on the amount of questions and discussion during the meetings.
Topics Covered
Introduction to the Veterinary Drug Approval Process
- Definitions - Is my product a new animal drug regulated by the FDA?
- Typical Steps in Veterinary Drug Development
- INAD / NADA technical sections
- Some differences between human and animal drug approval process
- FDA organization and jurisdiction
- Introduction to Federal Laws & Regulations (FD&CA, AMDUCA, etc.)
- FDA Guidance documents and other online resources
- Meetings with CVM
Developing the INAD/NADA Technical Sections
- Chemistry, Manufacturing, Controls (CMC)
- Effectiveness (go over GCP and the 7 major phases of clinical field studies)
- Target Animal Safety (go ver GLP and types of TAS data)
- Human Food Safety
- Environmental Impact
- Labeling
- Freedom of Information (FOI) Summary
- All Other Information (AOI)
Cell-Based Products (with focus on Regenerative Medicine) - NEW!
- VIP Program
- Type VII VMF
- Product Characterization Technical Section
Overview of Generic Animal Drugs (JINAD/ANADA)
- JINAD/ANADA technical sections
- CMC
- Bioequivalence (Safety and Efficacy)
- Human Food Safety
- Labeling
Minor Use Minor Species (MUMS)
- Assessment / Determination
- Designation
- Indexing
Animal Drug User Fees and related waivers
Animal Feed, OTC Drugs, Supplements, Medical Devices (brief overview)
Animal health products regulated by USDA & EPA (brief overview)
Non-Approval-Related Considerations
- Extra-Label Drug Use
- Compounding
- Noncompliance and Enforcement
- Pharmacovigilance
- Post-approval submissions for CMC changes
Alternative three half-days format
Future seminars could be given over three half-days if enough people would prefer this format (this is how our virtual seminars have been conducted). The material covered is the same with either format.
The meetings would be held in the morning and participants would have afternoons off to enjoy the premises, get some office work done remotely, or to go visit some nearby attractions.
Contact Us
We welcome your suggestions for future dates or locations, and whether you would prefer the two-day format or the three half-days format. Please send us an email! |
