ComplianceOnline

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(9:00 AM - 3:00 PM PDT)
  • 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)
  • Developing the NADA Technical Sections
    • Chemistry, Manufacturing, Controls (CMC)
    • Effectiveness
      • The 7 Major Phases of Clinical Field Studies
Day 02(9:00 AM - 3:00 PM PDT)
  • Developing the NADA Technical Sections (continued)
    • 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
  • 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
  • USDA & EPA
  • Non-Approval-Related Considerations
    • Extra-Label Drug Use
    • Compounding
    • Noncompliance and Enforcement
    • Pharmacovigilance
    • Post-approval submissions for CMC changes
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Mark A Hughes

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 by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,699.00

(One Dial-in One Attendee)

July 29-30, 2020, Virtual Seminar
(Registrations till June 5, 2020 - $1699)
(Registrations after June 5, 2020 - $1999)

$8,665.00

Group-Max. 10 Attendees

July 29-30, 2020, Virtual Seminar
(Registrations till June 5, 2020 - $8665)
(Registrations after June 5, 2020 - $10195)



Other Registration Option

By order form / PO#

Payment Mode

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

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

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

Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till June 30, 2020.

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 @ customercare@complianceonline.com

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.
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