BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T131420Z
UID:912c0847-2376-48a7-af77-d5fba1d631ca
DTSTART:20210518T083000
DTEND:20210519T083000
CLASS:PRIVATE
DESCRIPTION:\n
Description
\n\nThe Veterinary Drug Approval Process and FDA Regulatory Overs
ight
\n\n \;
\n\n*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
\nREGISTER TODAY!
\n\n \;
\n\nThe U.S. Food and Drug Administration&rsquo\;s
Center for Veterinary Medicine or CVM is responsible for the approval of v
eterinary drug products intended for both family pets and food-producing a
nimals. However\, FDA does not regulate all products intended for animal u
se. Jurisdiction over animal products including licensed biologics such as
vaccines is shared with a number of other federal agencies. For example\,
animal vaccines\, animal disease diagnostic devices and some animal biolo
gics are regulated by the U.S. Department of Agriculture&rsquo\;s Animal a
nd Plant Health Inspection Service or APHIS\; and products such as flea an
d tick collars are regulated by the Environmental Protection Agency.
\n\nThis seminar on veterinary medic
ine regulations will provide attendees with an understanding of FDA&rsquo\
;s veterinary drug approval process. This two day interactive course will
cover:
\n\n\n - Premarket ap
proval process
\n - Various sec
tions of a New Animal Drug Application
\n - Strategies for navigating the FDA approval process and for ex
pending product approval
\n - T
he nature of shared jurisdiction over veterinary products in certain cases
\n
\n\n \;
\n
\nSeminar Fee Includes:Lunch
\nAM-PM Tea/Coffee
\nSeminar Mater
ial
\nUSB with seminar presentation
\nHard copy of presentation<
br />\nAttendance Certificate
\n$100 Gift Cert for next seminar\n\n \;
\n\n \;
\n\nLearning Objectives:
\n\n
Upon completing this course on veterinary medicine regulations participant
s will:
\n\n\n - Understand
how the U.S. Food and Drug Administration regulates veterinary drug produc
t.
\n - Understand how FDA&rsqu
o\;s Center for Veterinary Medicine is organized.
\n - Discuss the process by which veterinary drug produ
cts are reviewed and approved.
\n - Learn how to open an INAD File and request fee waivers.
\n
- Obtain a working knowledge of various s
ections included within an NADA.
\n - Develop a deep understanding of what is needed to substantiate prod
uct characterization\, target safety and effectiveness.
\n -
Analyze FDA&rsquo\;s rules governing chemist
ry\, manufacturing and controls or CMC.
\n - Understand the various components of an animal field study t
o support product approval.
\n - Discuss the difference between FDA&rsquo\;s various user fees and fee wa
ivers.
\n - Identify the elemen
ts of an FDA compliant label.
\n - Develop a corporate compliance strategy covering labeling\, marketing
and advertising.
\n - Problem s
olving methods to mitigate regulatory enforcement risks.
\n - Explain how jurisdiction is split between v
arious Federal agencies in a certain cases.
\n - Learn how animal feed\, veterinary devices\, OTC drug pr
oducts and nutritional supplement are regulated in the U.S.
\n<
/ul>\n \;\n\nWho will Benefit:
\n\nThis course is designed for peo
ple tasked with developing and maintaining an animal health company&rsquo\
;s product portfolio and responsible for overseeing a company&rsquo\;s reg
ulatory strategies. This includes individuals responsible for overseeing r
egulatory affairs\, developing veterinary drug products\, evaluating new t
echnologies or applications\, and those tasked with ensuring corporate com
pliance. Among others\, this includes:
\n\n\n - Personnel new to the Animal Health Industry
\n - CRO professionals
\n -
Entrepreneurs looking to add value to their
products
\n - Regulatory profes
sionals
\n - Compliance profess
ionals
\n - U.S. Agents of Fore
ign Corporations
\n - Process o
wners
\n - Document control spe
cialists
\n - Record retention
specialists
\n - Legal Professi
onals
\n - Financial Advisors a
nd Institutional Investors
\n - Consultants\, Inspectors and cGxP Experts
\n
\n\n \
;
\n\n \;
\n\n------
-------
\nAGENDA
\n-----------
--
\n
\nDAY
01(8:30 AM - 4:30 PM)
\n \;\n\n - 08.30 AM - 09.00 AM: Registration
\n - <
span style="color:#000000\;">09.00 AM: Session Start
\n - Introduction to the FDA Veterinary Drug Approva
l Process
\n - Introduction to
Veterinary Drug Approval process\n
\n - FDA&rsquo\;s jurisdiction and Center&rsquo\;s relevant to Animal
Health\n
\n - Center for Fo
od Safety and Applied Nutrition (CFSAN)
\n - Center for Drug Evaluation and Research (CDER)
\n - Center for Veterinary Medicine (CVM
)
\n
\n \n - Speci
fics of CVM
\n - Intro to the
FDCA\, AMDUCA\, ADAA\, MUMS\, etc and guidance (GFI)\n
\n Overview of FDCA and regulations\n - Introduction to FDA GFI\n
\n \n
\n \n - O
verview of Veterinary Drug Develpment\n
\n - Discovery/Acquisition\n
\n - Preliminary Patent Protection Concerns
\n
\n \n - Submissions\n
\n - Open INAD File
\n -
NADA (8 sections)\n
\n - <
span style="color:#000000\;">5 Major Technical Sections
\n <
li>Chemistry\, Manufacturing and Controls (C
MC)
\n - Safety (target anim
al safety study)
\n - Effica
cy (field study)
\n - Human
Food Safety (human food safety studies for food-producing animals)<
/li>\n
- Environmental Impact (EA/CE)
span>
\n
\n \n
\n \n - Brief Description of cGxP (GMP\, GLP\, &\; GCP)
\n
\n \n - Approval Process: Che
mistry\, Manufacturing Controls\, Environmental Impact &\; Managing Cli
nical Trials\n
\n - CMC
\n
\n - API: name\, structure\, pro
perties
\n - API manufacturin
g
\n - Clinical Trial materia
l
\n - Final Formulation
\n
\n \n - Target Anim
al Safety\n
\n - Content and
format
\n - Final Study Repo
rts
\n - Monitoring and Repor
ting Adverse Drug Events
\n
\n \n - Human Food Safety\n
\n - Analysis of Drug Residues
\n - Toxicology
\n - Residue Chemistry
\n - Mi
crobial Food Safety
\n - Regu
latory Method Relied Upon by Sponsor
\n
\n \n -
Effectiveness\n
\n - Dosage Characterization
\n - Substantial evidence (e.g. dose confirmation and cl
inical field studies)
\n - Al
l other information related to effectiveness
\n - Proposed effectiveness-related labeling
\n
- Effectiveness Guidance Documents
\n - The 7 Major Phases of Animal
Field Studies
\n - Planning<
/span>
\n - Study Initiation<
/li>\n
- In-life Activities
\
n - Site close-out
\n - <
span style="color:#000000\;">Data management
\n - Biostatistical analysis
\n - Report writing
\n
\n \n - <
span style="color:#000000\;">Environmental Impact\n
\n - <
span style="color:#000000\;">Categorical Exclusions
\n Environmental Assessments (EA) \n
- Common EA Components
\n Environmental Impact Statements (EIS)
\n
\n \n - Labeling 21
CFR requirements
\n - FOI
\n - AOI
\n
\n
li>\n\n
\n
\nDAY 02(8
:30 AM - 4:30 PM)
\n \;\n\n - Animal Drug User Fees and Related Fee Waivers\n\n
\n - Veterinary Drug User Fees and Fe
e Reductions and Waivers\n\n
\n - Animal Drug User Fee Act (ADUFA) &ndash\; Applies to Innovators Only
\n - Animal Generic Drug Use
r Fee Act (ADGUF) &ndash\; Applies to Generic Manufacturers
\n
- ANADA sections\n
\n - BE (Safety &\; Efficacy)
\n - HFS
\n - A
ll others
\n
\n \n - Types of User Fees\n
\n - Animal Drug Application and Supplement Fee
\n - Animal Drug Product Fee
\n - Animal Establishment Fee
\n - <
span style="color:#000000\;">Animal Drug Sponsor fee
\n
\n \n - Types of Fee Waivers and
Reductions
\n - Procedures\,
Timing and FDA Evaluation of Waivers or Reductions
\n
\n
\n - FDA decision on approval
\n
\n \n Introduction to
FDA&rsquo\;s Regulation of Veterinary Feed\, OTC Drugs and Supplements\n \n - Animal Feed\n
\n - GRAS
\n - Feed Labeling
\n - AAFCO
\n - Veterin
ary Feed Directive (VFD)
\n
\n \n - Veterinary OTC Drugs and Nutritional Supplements\
n
\n - Regulatory Agencies
li>\n
- CVM Compliance Policy - CPG 690.
150 &\; CPG 690.100
\n
\n \n - Veterinary Medical Devices CPG 655.100
\n
\n \n USDA (CVB\, APHIS\, FSIS) &am
p\; EPA\n \n - USDA&rsquo\;s A
nimal and Plant Health Inspection Service\n
\n - Virus Serum Toxin Act\n
\n - Animal vaccines
\n - Animal biologics
\n - Animal disease diagnostic devices
\n
\n \n
\n \n - EPA\n \n
- Flea &\; Tick Products<
/li>\n
- Insect Repellants such as Equin
e Fly Sprays
\n - State Regis
trations
\n
\n \n \n \n Non-Approval-Related Considerations\n \n -
Extra-Label Drug Use
\n - Compounding
\n - Noncompliance and Enforcement\n
\n - FDA Enforcement Authority over Development\, Manufac
ture\, Marketing\, and Distribution\n
\n - FDA&rsquo\;s Office of Regulatory Affairs (ORA): Responsi
ble for field activities\, imports\, inspections\, and enforcement policy<
/span>
\n - Local\, State\, and Tri
bal governments
\n - CVM&rsq
uo\;s Office of Surveillance and Compliance
\n
\n \n - Types of Enforcement Actions
\n
\n \n - Pharmacovige
lence
\n - Post-approval submi
ssions\n
\n - CMC
\n - Safety
\n - Efficacy
\n
\n \n
\n
li>\n\n\n \;
\n\n \;
\n\n-------------
\nSPEAKER
\n-------------
\n
\nRob Hunter
\nVeterinary Drug Development Specialist\n\nSeminar Instructor Rob Hunter has 20
years of veterinary and human drug development experience with NASA\, Pfi
zer\, Elanco\, Parnell\, and Provetica. He has contributed to the approval
s for Revolution®\;\, Dectomax®\;\, Ovugel®\;\, and Pulmotil®\
;\, with others currently in development or under regulatory review. Inter
nationally recognized subject matter expert on pharmacokinetics\, antimicr
obial PK/PD\, interspecies allometry\, drug metabolism\, bioequivalence\,
and tissue residues/human food safety along with corresponding bioanalytic
al support. Dr. Hunter has served on and chaired several AHI committees an
d represented the U.S. veterinary pharmaceutical industry on the VICH bioe
quivalence expert committee. He has represented various companies at CVM/F
DA\, EMA/CVMP\, APVMA\, VDD (Canada)\, NVQRS/QIA (South Korea)\, Thailand
FDA\, NVAL (Japan)\, Ministry of Agriculture (Vietnam)\, and IVDC (China)
regarding specific products\, issues\, and/or policies.
\n\n&
nbsp\;
\n\n \;
\n\n \;
\n\nPlease contact the event manager Marilyn (marilyn.b.turner(at)nye
ventslist.com ) below for: \;
\n- Discounts for multiple particip
ants.
\n- Require a price quotation.
\n- Require to pay by wire
transfer or PayPal
\n- Invitation letter for visa applications
\
n
\nNO REFUNDS ALLOWED ON REGISTRATIONS \;
\n---------------
--------------------------------------------------
\nThis Event is Br
ought to You by: \;
\nMETRICSTREAM INC - NewYorkEventsList
\
nhttp://www.NyEventsList.com
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nhttp://www.SFBayEventsList.com
\n
\nMYL171013CEV MYL171117OTH
span>
\n
SUMMARY:The Veterinary Drug Approval Process and FDA Regulatory Oversight (
com) A
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SUMMARY:The Veterinary Drug Approval Process and FDA Regulatory Oversight (
com) A
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