Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies: One and a Half day In-Person Seminar

By: Deborah D. Linton, Ph.D., DL Veterinary Consulting, LLC
Coming soon.. Please contact customer care for new schedule
Course “Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies” has been pre-approved by RAPS as eligible for up to 10 credits towards a participant’s RAC recertification upon full completion.

We need the below information to serve you better

Course Description:

Studies of veterinary drugs are required to be conducted under VICH Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) for approval by the various regulatory agencies. Clinical trial monitoring, quality audit procedures, collection of valid data, and conduct of both clinical trials and target animal safety studies are regulatory requirements. Additionally, the FDA inspects studies submitted for regulatory approval. Understanding core concepts of veterinary drug studies is vital for organizations and personnel involved with submitting studies to regulatory agencies.

In this 1.5 day workshop conference you will learn the concepts of VICH GCP, recognize the difference between GCP and GLP and when each is used, gain an understanding of Target Animal Safety studies, and gain tools and procedures for writing clinical trial protocols, implementing quality auditing procedures, monitoring clinical trials, and assessing data validity. Practical exercises will be used to illustrate data validity and monitoring tools. Additionally, tips for managing FDA inspections of clinical trials will be presented.

Learning Objectives:

Upon completing this course participants should:

  • Understand the concepts of VICH GCP
  • Recognize the similarities and differences between GCP and GLP and their application to trial types
  • Understand how GLPs can be implemented
  • Understand Target Animal Safety studies and the structure and requirements of margin of safety studies
  • Have tools to write good clinical trials protocols
  • Understand the differences between quality audit procedures and quality assurance procedures
  • Understand the concepts of clinical trial monitoring
  • Be able to identify the attributes of valid data and gain tools to review electronic and hard copy data to assess data integrity and fraud
  • Have tools to handle an FDA inspection

Who Will Benefit:

This course is designed for people wanting to learn the core concepts of veterinary drug studies required for regulatory approvals. Emphasis will be placed on veterinary clinical trials, including protocols, monitoring, data review, and quality assurance. Target animal safety studies, GLPs, and procedures for FDA inspections will also be discussed. Following personnel will benefit from the course:

  • Individuals involved in academia interested in veterinary trials
  • Human pharmaceutical professionals interested in veterinary trials
  • Veterinarians interested in regulated research
  • Clinical trial managers
  • Product development professionals
  • Quality assurance professionals
  • Regulatory professionals
  • Professionals seeking VICH GCP refresher training
  • Contract research organization personnel

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  1. Course Objectives
  2. VICH and VICH Good Clinical Practice (GCP) (VICH GL9)
    1. History of VICH
    2. VICH GCP Objectives
    3. GCP Concepts
      1. Personnel Roles and Duties
      2. Facilities
      3. Standard Operating Procedures (SOPs)
      4. Protocols and Data Forms
      5. Investigational Veterinary Product (IVP)
      6. Study File
      7. Final Study Report (FSR) and FSR Amendments
      8. Document Submission to FDA and Archiving
  3. GCP vs. GLP
    1. Key Areas and Differences
    2. Which to Use
    3. US GLP vs. OECD GLP
    4. Implementing GLPs
  4. Target Animal Safety(TAS) Studies (VICH GL43)
    1. What are TAS Studies?
    2. Regulations
    3. Margin of Safety Study
    4. Other Safety Studies
    5. Reproductive Safety
  5. More on Protocols
    1. Definitions in Regulations
    2. Protocol Components
    3. Control of Bias
      1. Randomization and Blocking
      2. Masking
      3. Comparator(s)
      4. Sampling Plan
    4. Statistical Plan
    5. Changes to Protocol
    6. Protocol Tips
  6. Quality Assurance Unit and VICH GCP Quality Procedures
    1. VICH GCP References to QA
    2. Quality Assurance Unit (QAU) Definition
    3. QAU vs. Quality Control
    4. Beyond QC
    5. Advantages of QAU for GCPs
    6. Implementing a QAU
    7. Evaluating a QAU
Day Two (8:30 AM – 12:00 PM)
  1. Monitoring Animal GCP Trials
    1. Duties of a Monitor
    2. Phases to Monitor
    3. Remote Monitoring
    4. Monitor Training and Mentoring
    5. Contract Research Organizations
    6. A Monitoring Example
  2. Valid Data and Data Integrity
    1. Attributes of Valid Data (ALCOA)
    2. How to Correct Paper Data
    3. Common Paper Data Problems
    4. Common Data Problems
    5. A Data Exercise
    6. Good Data Collection Habits
    7. Data Concepts
  3. Managing FDA GCP Inspections
    1. For the Inspection Coordinator
    2. For the Investigator
    3. Before the Inspection
    4. Inspection Room
    5. Role of the Inspection Coordinator
    6. Documents
    7. The Inspection Process
    8. 483 Response
    9. Questions that May Occur
    10. General Issues that Can Arise
  4. Putting it to Work
    1. Summary
    2. Role of Regulator
    3. Non-Compliance
    4. Going Forward
  5. Questions

Meet Your Instructor

Deborah-Linton-90X112
Deborah D. Linton
Ph.D., DL Veterinary Consulting, LLC

Dr. Linton has more than 20 years of experience in veterinary drug product development for both the US and EU. After completing degrees at Hanover College (B.A. mathematics) and Purdue University (M. S. and Ph.D., population genetics), she worked for veterinary pharmaceutical companies for 16 years at Cyanamid, Fort Dodge Animal Health, and Nexcyon Pharmaceuticals, Inc., where she held positions in clinical trial management, statistics, product development, and quality assurance. Prior to joining Nexcyon, she was a consultant in animal health development for 10 years and returned to consultancy work in 2014. She is active in the Society of Quality Assurance, and has spoken or trained on various quality assurance, clinical trial monitoring, data validity and compliance topics within veterinary drug development.

Register Online

Register Online

$0
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at editor@grcseminars.com

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965


Download Registration Form

Yes, I want to attend "Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies: One and a Half day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

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 @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

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

Cancellations and Substitutions:

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 $200 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 seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future GRC Seminars 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 GRC Seminars cancels the seminar, GRC Seminars 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.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Sponsors

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

Local Attractions

Walt Disney World Resort
This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.

Magic Kingdom Park
Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.

Universal Studios Orlando
Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.


Wet 'n Wild
Have a splashing good time at one of the country's premier water parks, offering rides for all ages.

Pointe Orlando
Featuring open-air shopping, dining and entertainment, with more than 40 specialty retailers, delicious restaurants, and exciting entertainment.

Holy Land Experience
The Living Bible theme park features a re-creation of ancient Jerusalem, craft shops, performances, food stands, and the Temple of the Great King.