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Veterinary Drug Regulatory Life Cycle (A to Z)
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AAVPT Veterinary Drug Regulatory Life Cycle (A to Z)

 

Appendix 1: Commonly Used Acronyms
Appendix 2: Summary of CVM Guidances for Industry

 

Monday February 28, 2011

AM session: Introductions, Overviews, General Information

9:00 – 9:15AM – Products Regulated By CVM – Vitolis Vengris
9:15 – 9:45AM – Introduction to the Course, Drug Approval Philosophy, ADUFA/AGDUFA – Steve Vaughn
9:45 – 10:00AM - Comparison to human drug development – Mike Murphy
10:30 – 10:45 AM – What Happens When a Submission Gets to DCU? – Beth Canter
10:45 – 11:20AM – Administrative Issues – Beth Luddy
11:20 – 11:40 AM – Patent term restoration vs. exclusivity – Urvi Desai
1:00 – 1:30PM – Communication with ONADE – Angela Clarke
1:30 – 2:00PM – Pre-Approval Process, INAD vs. NADA – Barb Leotta

PM Session: Chemistry, Manufacturing, and Controls Technical Section

2:00 – 2:30PM – The Big Picture of a Long-Term Commitment – James Nitao
2:45 – 3:15PM – Overview of Question based Review (QbR) (QbR-Drug Product example) – Becky Owen

QbR:  Format and Questions – Elizabeth Cormier

3:15 – 3:45PM – Pre-approval GMP facility inspections, Scheduling and Coordinating – Robin Stone 3:45 – 4:15PM – Lifecycle based approach – Sudesh Kamath

 

Tuesday, March 1, 2011

AM Session: Effectiveness Technical Section

8:00 – 8:30AM – Using PK as a tool in product development and regulation – Marilyn Martinez
8:30 – 8:50AM – Dosage characterization – Sanja Modric
8:50 – 9:20AM – Effectiveness Overview – Linda Wilmot
9:20 – 9:50AM – Statistical Overview – Jean Recta
9:50 – 10:20AM – Effectiveness evaluation for production drugs (HFV-120): – Danielle Sholly
10:20 – 10:35AM – BREAK
10:35 – 11:05AM – Effectiveness evaluation for therapeutic drugs for food animals (HFV-130) – Michelle Kornele
11:05 – 11:35AM – Effectiveness Evaluation for therapeutic drugs for companion animals HFV-110) – Ed Chen 

PM Session: Target Animal Safety (TAS) Technical Section

1:00 – 1:20PM – Intro to Safety Principles & Pharmacological and Toxicological characterization – Laura Hungerford
1:20 – 1:40PM – TAS Overview –Cindy Burnsteel
1:40 – 2:00PM – Understanding Regulations Concerning Electronic Records – Vernon Toelle
2:00 – 2:20PM – TAS Statistical Overview – Vicki Lancaster
2:20 – 2:50PM – TAS Evaluation for production drugs (HFV-120) – Amey Adams
3:10 – 3:35PM – TAS Evaluation for therapeutic drugs for food animals (HFV-130) – Emily Smith
3:35 – 4:05PM – Evaluation of TAS for therapeutic drugs for companion animals (HFV-110) – A'ndrea Van Schoick
4:05 – 4:35PM – Use of PK in support of TAS – Marilyn Martinez

 

Wednesday March 2, 2011

8:00 – 8:20AM - Human abuse potential assessment and scheduling – Germaine Connolly

AM Session: Human Food Safety (HFS) Technical Section

8:20 – 9:00AM – Toxicology – Tong Zhou
9:00 – 9:45AM – Residue Chemistry – Julia Oriani
9:45 – 10:30AM – Microbial Food Safety – Ruby Singh and Silvia Pineiro
10:45 – 11:15AM – Post-Approval Violative Residues – Debbie Cera

AM Session II: Environmental Safety

11:15 – 11:45 - Environmental Safety – Wesley Hunter

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

1:00 – 1:20PM – Labeling – Ann Stohlman
1:20 – 1:40PM – All Other Information – Sharon Chase
1:40 – 2:00PM – Freedom of Information Summary – Harlan Howard
2:00 – 2:20PM – Administrative NADA – Laurie Hanna
3:00 - 3:20PM - Nomenclature Considerations for Defining Veterinary Products - Martinez and Modric.

PM Session II: Generics

3:00 – 3:30PM – The Generic Drug Approval Process - Katherine Weld & Sharon Ricciardo
3:30 – 4:00PM – Suitability Petitions – Ken Harshman
4:00 – 4:30PM – Biowaiver requests – Ian Hendricks

 

Thursday March 3, 2011

8:00 – 8:40AM – MUMS – Meg Oeller

AM Session I: Animal Feeds

8:40 – 9:10AM – Non-Medicated Feed: Regulatory oversight of animal food – Geoff Wong and Tom Hendricks
9:10 – 10:00AM – Medicated Feeds Overview – Dragan Momcilovic
Post Approval Activities – Jason Smith
Medicated Feeds Licensing Program – Isabel Pocurull

AM Session II: Compliance

10:30 – 10:45AM – Compliance Overview – Neal Bataller (Slides not provided)
10:45 – 11:05 – CPGM 7371.001 – Marea Harmon
11:05 – 11:25AM – BIMO – Vernon Toelle
11:25 – 11:45AM – Recalls – Dillard Woody

PM Session: Surveillance

1:00 – 1:15PM – Overview of post-approval reporting requirements – Tom Modric
1:15 – 1:40PM – Quantity marketed – Jinhee Lee & Beth Anne Grove
1:40 – 1:55 PM – Electronic registration & drug listing – Charise Kasser
1:55 – 2:25PM – Introduction to medication error prevention – Linda Kim-Jung
2:25 – 2:55PM - Pharmacovigilance – Tina Burgess
3:25 – 3:55PM – Post-approval experience, labeling issues – Stacey Shults
3:55 – 4:25PM – Advertising issues, effectiveness claims – Mike Murphy
4:25 – 4:55PM – Communicating risk & fair balance in promotional material – Dottie McAdams

 

Friday March 4, 2011

AM Session I: Research at CVM

8:00 – 9:20AM – Office of Research – Mike Myers

AM Session II: Biotechnology

9:35 – 10:00AM – Biotechnology – Brinda Dass
10:15 – 10:40AM – Biotechnology continued – Malini Mansharamani

AM Session II: Miscellaneous Topics

10:40 – 11:00AM – Opportunity for Public Input – Diane Heinz
11:00 – 11:20AM – Unapproved Drug Initiative – Beth Luddy
11:20 – 11:40AM – CVM Website Virtual Tour – Laura Bradbard

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