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U.S. Department of Health and Human Services

Animal & Veterinary

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Agenda for the AAVPT Veterinary Drug Regulatory Life Cycle Course

 

Monday February 28, 2011

AM session: Introductions, Overviews, General Information

8:30 AM – Welcomedisclaimer iconBernadette Dunham 

8:45 – 9:00 AM – CVM Overview – Bernadette Dunham

9:00 – 9:15AM – Products Regulated By CVMdisclaimer iconVitolis Vengris

9:15 – 9:45AM – Introduction to the Course, Drug Approval Philosophy, ADUFA/AGDUFAdisclaimer iconSteve Vaughn

9:45 – 10:00AM - Comparison to human drug developmentdisclaimer iconMike Murphy

10:00 – 10:15 – Patent term restoration vs. exclusivitydisclaimer iconUrvi Desai

10:15 – 10:30 AM – BREAK

10:30 – 10:45 AM – What Happens When a Submission Gets to DCU?disclaimer iconBeth Canter

10:45 – 11:20AM – Administrative Issuesdisclaimer iconBeth Luddy

11:20 – 11:40 AM – Q/Adisclaimer icon

12:00- 1:00 PM – LUNCH

PM Session: Chemistry, Manufacturing, and Controls Technical Section

1:00 – 1:30PM – Communication with ONADEdisclaimer iconAngela Clarke

1:30 – 2:00PM – Pre-Approval Process, INAD vs. NADAdisclaimer iconBarb Leotta 

2:00 – 2:30PM – The Big Picture of a Long-Term Commitmentdisclaimer iconJames Nitao

2:30 – 2:45PM – Q/Adisclaimer icon

2:45 – 3:15PM – Overview of Question based Review (QbR) (QbR-Drug Product example) – Becky Owen/ Elizabeth Cormier
Becky Owendisclaimer icon

Elizabeth Cormierdisclaimer icon

3:15 – 3:45PM – Pre-approval GMP Facility Inspections, Scheduling and Coordinatingdisclaimer iconRobin Stone

3:45 – 4:15PM –Lifecycle based approachdisclaimer iconSudesh Kamath

4:15 – 4:45PM – Q/Adisclaimer icon
 

Tuesday, March 1, 2011

AM Session: Effectiveness Technical Section

8:00 – 8:30AM – Using PK as a tool in product development and regulationdisclaimer iconMarilyn Martinez

8:30 – 8:50AM – Dosage characterizationdisclaimer iconSanja Modric

8:50 – 9:20AM – Effectiveness Overviewdisclaimer iconLinda Wilmot

9:20 – 9:50AM – Statistical Overviewdisclaimer iconJean Recta

9:50 – 10:20AM – Effectiveness evaluation for production drugsdisclaimer icon (HFV-120) – Danielle Sholly

10:20 – 10:35AM – Q/Adisclaimer icon

10:35 – 11:05AM – Effectiveness evaluation for therapeutic drugs for food animalsdisclaimer icon (HFV-130) – Michelle Kornele

11:05 – 11:35AM – Effectiveness Evaluation for therapeutic drugs for companion animalsdisclaimer icon (HFV-110) – Ed Chen

11:35 – noon – Q/Adisclaimer icon

12:00- 1:00 PM – LUNCH

PM Session: Target Animal Safety (TAS) Technical Section

1:00 – 1:20PM – TAS Overviewdisclaimer iconCindy Burnsteel

1:20 – 1:40PM – Intro to Safety Principles & Pharmacological and Toxicological Characterizationdisclaimer iconLaura Hungerford

1:40 – 2:00PM – Understanding Regulations Concerning Electronic Recordsdisclaimer iconVernon Toelle

2:00 – 2:20PM – TAS Statistical Overviewdisclaimer iconVicki Lancaster

2:20 – 2:50PM – TAS Evaluation for production drugsdisclaimer icon (HFV-120) – Amey Adams

2:50 – 3:10PM – Q/Adisclaimer icon

3:10 – 3:35PM – TAS Evaluation for therapeutic drugs for food animalsdisclaimer icon (HFV-130) – Emily Smith

3:35 – 4:05PM – Evaluation of TAS for therapeutic drugs for companion animalsdisclaimer icon (HFV-110) – A’ndrea Van Schoick

4:05 – 4:35PM – Use of PK in support of TASdisclaimer iconMarilyn Martinez

4:35 – 5:00PM – Q/Adisclaimer icon

 

Wednesday March 2, 2011

AM Session: Human Food Safety (HFS) Technical Section

8:00-8:20AM - Overview of the VPRFdisclaimer icon - Jane Owens

8:20 – 9:00AM - Human abuse potential assessment and schedulingdisclaimer icon  – Germaine Connolly

9:00 – 9:30AM – Microbial Food Safety – Ruby Singh and Silvia Pineiro

Ruby Singhdisclaimer icon

Silvia Pinerodisclaimer icon

9:30 – 10:30AM – Residue Chemistrydisclaimer iconJulia Oriani

Toxicologydisclaimer iconTong Zhou

10:30 – 10:45AM – Q/Adisclaimer icon

10:45 – 11:15AM – Post-Approval Violative Residuesdisclaimer iconDebbie Cera

11:15 - 11:30AM - Q/Adisclaimer icon 

AM Session II: Environmental Safety

11:30 – 11:45 - Environmental Safetydisclaimer iconWesley Hunter 

11:45 – noon – Q/Adisclaimer icon

12:00 - 1:00 PM – LUNCH

PM Session I: Minor Technical Sections, FOI Summary, NADA

1:00 – 1:20PM – Labelingdisclaimer iconAnn Stohlman

1:20 – 1:40PM – All Other Informationdisclaimer iconSharon Chase

1:40 – 2:00PM – Freedom of Information Summarydisclaimer iconHarlan Howard

2:00 – 2:20PM – Administrative NADAdisclaimer iconLaurie Hanna

2:20 – 2:45PM – Q&Adisclaimer icon

2:45 – 3:00PM – BREAK

PM Session II: Generics

3:00 – 3:15PM – Nomenclature Considerations for Veterinary Productsdisclaimer iconSanja Mordric

3:00 – 3:30PM – The Generic Drug Approval Process - Katherine Weld & Sharon Ricciardo

Sharon Ricciardodisclaimer icon

Katherine Welddisclaimer icon

3:30 – 3:45PM – Q/Adisclaimer icon 

3:45 – 4:00PM – Suitability Petitionsdisclaimer iconKen Harshman 

4:00 – 4:30PM – Biowaiver requestsdisclaimer iconIan Hendricks

4:30 – 5:00PM – Q/Adisclaimer icon 

 

Thursday March 3, 2011

8:00 – 8:40AM – MUMSdisclaimer iconMeg Oeller

AM Session I: Animal Feeds

8:40 – 9:10AM – Non-Medicated Feed: Regulatory Oversight of Animal Food – Geoff Wong and Tom Hendricks
Geoff Wongdisclaimer icon

Tom Hendricksdisclaimer icon

9:10 – 10:00AM – Medicated Feeds Overviewdisclaimer iconDragan Momcilovic

Post Approval Activitiesdisclaimer iconJason Smith

Medicated Feeds Licensing Programdisclaimer iconIsabel Pocurull

10:00 – 10:15AM – Q/Adisclaimer icon

10:15 - 10:30AM – BREAK

AM Session II: Compliance

10:30 – 10:45AM – Compliance Overviewdisclaimer iconNeal Bataller

10:45 – 11:05 – CPGM 7371.001disclaimer iconMarea Harmon

11:05 – 11:25AM – BIMOdisclaimer iconVernon Toelle

11:25 – 11:45AM – Recallsdisclaimer iconDillard Woody

11:45 - noon – Q/Adisclaimer icon

12:00 – 1:00PM – LUNCH

PM Session: Surveillance

1:00 – 1:15PM – Overview of post-approval reporting requirementsdisclaimer iconTom Modric

1:15 – 1:40PM – Quantity marketeddisclaimer iconJinhee Lee & Beth Anne Grove

1:40 – 1:55 PM – Electronic registration & drug listingdisclaimer iconCharise Kasser

1:55 – 2:25PM – Introduction to medication error preventiondisclaimer iconLinda Kim-Jung

2:25 – 2:55PM - Pharmacovigilancedisclaimer iconTina Burgess

2:55 – 3:10PM – Q/Adisclaimer icon

3:10 – 3:25PM – BREAK

3:25 – 3:55PM – Post-approval experience, labeling issuesdisclaimer iconStacey Shults

3:55 – 4:25PM – Advertising issues, effectiveness claimsdisclaimer iconMike Murphy

4:25 – 4:55PM – Communicating risk & fair balance in promotional materialdisclaimer iconDottie McAdams

4:55 – 5:15PM – Q/Adisclaimer icon

 

Friday March 4, 2011

AM Session I: Research at CVM

8:00 – 9:20AM – Office of Researchdisclaimer iconMike Myers

9:20 – 9:35AM – Q/Adisclaimer icon

AM Session II: Biotechnology

9:35 – 10:00AM – Biotechnologydisclaimer iconBrinda Dass

10:00 – 10:15AM – BREAK

10:15 – 10:40AM – Biotechnology continueddisclaimer iconMalini Mansharamani

AM Session II: Miscellaneous Topics

10:40 – 11:00AM – Opportunity for Public Inputdisclaimer iconDiane Heinz

11:00 – 11:20AM – Unapproved Drug Initiativedisclaimer iconBeth Luddy 

11:20 – 11:40AM – CVM Website Virtual Tourdisclaimer iconLaura Bradbard

11:40AM - Noon – Q/Adisclaimer icon

Noon-12:15PM - Summarydisclaimer icon - Sanja Modric

12:15-12:30 - Closingdisclaimer icon