Veterinary Drug Approval Process | FDA’s Center for Veterinary Medicine (CVM) Regulations

Cart

Contains 0 items
Total: $0.00
View Shopping Cart

Toll Free:
+1-888-717-2436

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

This two-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

Learning Objectives:

Key goals of the seminar will include learning:

How the U.S. Food and Drug Administration (FDA) regulates animal drug products.
How FDA’s Center for Veterinary Medicine is organized.
The process by which veterinary drug products are reviewed and approved.
How to open an Investigational New Animal Drug (INAD) File.
The FDA’s various user fees, what fee waivers are available, and how to request a fee waiver.
The various technical sections included in a New Animal Drug Application (NADA).
What information is needed to substantiate product characterization, target animal safety and effectiveness.
An overview of FDA’s rules governing chemistry, manufacturing and controls (CMC).
The various components of an animal field study to support product approval.
How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.

Who will Benefit:

This course is designed primarily for people tasked with developing new animal drugs for an animal health company or a human pharmaceutical company. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, or evaluating new technologies or applications. Among others, this includes:

Personnel new to the Animal Health Industry
CRO professionals
Entrepreneurs looking to add value to their products
Regulatory professionals
Compliance professionals
U.S. Agents of Foreign Corporations
Legal Professionals
Financial Advisors and Institutional Investors

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

The real-time and live presentation as in in-person events
Private chat for company-specific conversation – the same as you would get in an in-person seminar
Opportunities to connect with your peers to share knowledge at a different time and have group discussions
Live workshop activities
Live Q&A during the event and offline Q&A assistance after the event
As usual more content, activities and case studies and now adding homework for a comprehensive understanding
Certification

Download Brochure

Day 01(9:00 AM to 1:00 PM PST)

Introduction to the Veterinary Drug Approval Process
- Definitions
- INAD/NADA technical sections
- Some differences between human and animal drug approval process
- FDA organization and jurisdiction
  - FDA Centers relevant to Animal Health
- Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
- FDA Guidance documents and other online resources
- Discovery/Acquisition - Preliminary Patent Protection Concerns
- INAD/NADA Phased Review
  - Open an INAD File
  - Submit Early Information
  - Phased Review of Technical Sections
- Meetings with CVM
- Brief description of cGxP (GMP, GLP, GCP)

Day 02(9:00 AM to 1:00 PM PST)

Developing the NADA Technical Sections
- Chemistry, Manufacturing, Controls (CMC)
- Effectiveness
  - The 7 Major Phases of Clinical Field Studies
- Target Animal Safety (TAS)
- Human Food Safety
- Environmental Impact
- Labeling
- Freedom of Information (FOI) Summary
- All Other Information (AOI)
Overview of Generic Animal Drugs (JINAD)
- Submissions - ANADA sections
  - CMC
  - Bioequivalence (Safety & Efficacy)
  - Human Food Safety
  - Labeling

Day 03(9:00 AM to 1:00 PM PST)

Minor Use Minor Species (MUMS)
- Designation
- Indexing
Marketing Exclusivity & Exclusive Marketing Rights
Animal Drug User Fees and related waivers
Animal Feed, OTC Drugs, Supplements, Medical Devices
Animal health products regulated by USDA & EPA
Non-Approval-Related Considerations
- Extra-Label Drug Use
- Compounding
- Noncompliance and Enforcement
- Pharmacovigilance
- Post-approval submissions for CMC changes
Review of the Typical Steps in Veterinary Drug Development

Because procurement is handled differently in every company, we examine basic considerations only.

Mark Hughes
Consultant, Hughes Veterinary Consulting

Dr. Mark Hughes, DVM, MS, has over 11 years of experience in veterinary drug product development and over 20 years of experience in laboratory animal medicine, development of in-vitro diagnostic tests, and research in animal reproduction. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals and livestock.

Register Now

1
Simu Live
(On-demand Streaming)

Online using Credit card

$2,599.00

(One Dial-in One Attendee)

(After registration, we will video stream the training on your convenient dates)

$13,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training on your convenient dates)

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Download the Order Form
Fill this form with attendee details & payment details
Fax it to +1-650-362-2367, or
Email it to [email protected]

Payment Mode

By Check -

Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.

Offers:

Early bird seats are limited and based on first-come, first-serve.

Multiple offers cannot be combined.

Testimonials

See What People Say About Us

Overall this training was very informative, Mark was able to adapt to the virtual training well. Mark did well in presenting the information and continually verifying that everyone was following. He encouraged input and participation. The only thing I may recommend for future virtual sessions is maybe some interactive slides ("test your understanding", etc.). I enjoyed the training and I definitely left with knowledge that will be beneficial.

Regulatory and Quality Affairs Manager,

EPiQ Animal Health

The presenter for this seminar, Mark Hughes, clearly has a great depth of knowledge and experience with this subject matter. The notes are especially well done and documented and I believe the information shared in the seminar and the notes will be a great resource for us. Mark had many great examples and anecdotes from his experience that brought the material to life. Maybe at some point running through a scenario of drug development from the idea, to informational meetings with FDA/CVM, development of the protocol, pre-submission meetings with the FDA/CVM, that lays out the steps and timing for an example of the process, perhaps with and without MUMS designation.

Clinical Trial Manager,

STATKING Clinical Services