Toxicology & Risk Assessment
Join the Australasian College of Toxicology & Risk Assessment (ACTRA) in a unique webinar series that commenced in June 2020! The webinar series will cover two overarching themes in relation to toxicology and risk assessment in Australia:
- Lessons learnt from case studies.
- Practical applications of theoretical concepts.
These sessions will provide you with an opportunity to gain insight from Australia’s most accomplished and experienced toxicologists and risk assessors, and more importantly encourage an open forum for questions and discussion.
Attending webinars counts towards your continuing education credit points at the rate of one point per webinar.
ACTRA is pleased to present this webinar on “Comments on FDA/CVM guidance for industry #159 (VICH GL36): Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI” by Silvia Pineiro, on May 2nd.
ACTRA Webinar Series with Q&A – Session #33
Topic: “Comments on FDA/CVM guidance for industry #159 (VICH GL36): Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI”
Date: Thursday 2nd May 2024
Time: 3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Silvia Pineiro
REGISTER NOW
Comments on FDA/CVM guidance for industry #159 (VICH GL36): Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI)
The U.S. Food and Drug Administration (FDA) conducts human food safety assessments of new animal drugs for use in food-producing animals to address human exposure to drug residues in food derived from treated animals. The Center for Veterinary Medicine (CVM) develops guidance documents to inform sponsors of the scientific data and/or information that may provide an acceptable basis to determine that the residue of a new animal drug in or on food, when consumed, presents a reasonable certainty of no harm to humans. Guidance documents describe recommended approaches for providing human food safety scientific data and/or information. However, alternate approaches also may be appropriate. Thus, sponsors are encouraged to discuss with CVM whether an alternate approach may be appropriate for specific new animal drugs. One of the issues that needs to be addressed is the safety of antimicrobial drug residues in edible tissues on the human intestinal microbiome (https://www.fda.gov/animal-veterinary/guidance-industry/guidance-number).
Literature available in the public domain describes the crucial role played by the human intestinal microbiome. Some authors even call it an “additional organ”, an “endocrine organ”, and the “forgotten organ”, in which changes in the composition and function of intestinal microbes (microbiota dysbiosis) have been associated with diseases ranging from localized gastroenterological disorders to neurologic, respiratory, metabolic, hepatic and cardiovascular illnesses.
This session aims to discuss FDA/CVM’s Guidance for Industry #159 (VICH GL36) “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI”, addressing the impact of residues on the human intestinal microbiome, protecting beneficial human intestinal microbiome, as well as discussing recommended data and scientific gaps.
Session Dot Points:
- Understand the stepwise approach used to assess the need to calculate a microbiological acceptable daily intake.
- Discuss the disruption of the colonization barrier and increased population(s) of resistant bacteria endpoints of human health concern.
- Discuss current data gaps and challenges.
About the Presenter
Silvia Piñeiro received her Ph.D. from the University of Bahia Blanca, Argentina, and has held positions as a postdoctoral research associate, assistant professor, professor and senior scientific associate, at the University of Iowa, University of Buenos Aires, University of Salvador, BioSidus S.A. (Biotech Company), and for 7 years at the University of Maryland, School of Medicine. From 2009 until 2022, she held a visiting faculty scientist position at the School of Medicine, Johns Hopkins University. In 2009, she joined FDA where she currently is a senior regulatory review scientist in the area of microbial food safety, Division of Human Food Safety, CVM/FDA. Much of the work in Dr. Piñeiro’s division is on Agency policy development and national/international work on microbial resistance and microbiome issues. Her primary role is reviewing submissions towards the drug approval of new animal drugs from the perspective of the human intestinal microbiome (FDA/GFI#159 – VICH GL#36) and antimicrobial resistance (FDA/GFI#152). Also, she collaborates on research projects addressing regulatory needs and data gaps on antimicrobial resistance and the impact of residues on human intestinal microbiome. She served as chair of the FDA Interagency Microbiome Working Group and currently, she serves as FDA representative for the FDA-NIH-NIST-USDA Joint Agency Microbiome (JAM) Leadership Committee. Additionally, she served for over 15 years in the ASM Board of Directors MD branch, as well as in the ASM COMS governance and in the role of Community Leader for ASM’s Antimicrobial Agents and Resistance (AAR) Community. She served as an expert member, co-chair and chair of the Microbiological Acceptable Daily Intake Expert Working Group (mADI EWG) at the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), which is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. Since 2016, she has been appointed to participate as a scientific expert member of the FAO/WHO Expert Committee on Food Additives (JECFA), and since 2021, she is serving as the lead scientific expert member appointed by WHO to address the impact of residues on the human intestinal microbiome. Additionally, since 2021 she served as WHO expert participating in the Joint FAO/WHO Meeting on Pesticide Residues (JMPR).
Date: Thursday 2nd May 2024
Time: 3:00PM – 4:00PM AEST (Melb/Syd time)
FEES PER SESSION (incl. GST)
- ACTRA Members – $25
- Non-Members – $50
- Student members – $15
- Organisation – $200 (maximum of 10 log ons)
REGISTRATION DEADLINE: By 3 pm, Wednesday May 1st
CPD POINTS (For ACTRA Registration Scheme): Earn up to 1 CPD Point per session.
Level of previous experience required: Intermediate
PAST WEBINARS
Recordings of each of the webinars listed below can be purchased via the following link:
PURCHASE PAST WEBINARS
Pro tip: Please take note of the number of the webinar which you would like to purchase from the list below (1-30). This will make the purchase process much easier.
The Fees for purchasing past webinars are:
ACTRA Members: $30 per webinar
Non members: $60 per webinar
WEBINAR DETAILS
ACTRA Webinar Series with Q&A – Session #32
Topic: “enHealth Guidance for the human health risk assessment of volatile chlorinated hydrocarbon vapour intrusion”
Date: Thursday 4th April 2024
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Ian Delaere
ACTRA Webinar Series with Q&A – Session #31
Topic: “What currently keeps the OECD Test Guideline Programme busy?”
Date: Thursday 7th March 2024
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Anne Gourmelon
ACTRA Webinar Series with Q&A – Session #30
Topic: “Human health exposure from legacy gold mining sites using bioaccessibility, bioavailability and speciation”
Date: Thursday 2nd November 2023
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Farzana Kastury
ACTRA Webinar Series with Q&A – Session #29
Topic: ‘The new wave synthetic opioid abuse, trends, trafficking, and the road ahead for public health professionals’
Date: Thursday 5th October 2023
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Paul Newell
ACTRA Webinar Series with Q&A – Session #28
Topic: “Guess who’s back – or maybe they never left?”
Date: Thursday 6th July 2023
4:00PM – 5:00PM AEST (Melb/Syd time)
Presenter: Dr Carolyn Brumley (FACTRA)
ACTRA Webinar Series with Q&A – Session #27
Topic: “Health effects associated with aircraft cabin air quality (“aerotoxic syndrome”)”
Date: Thursday 4th May 2023
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Adjunct Professor Brian G. Priestly
ACTRA Webinar Series with Q&A – Session #26
Topic: “Risk communication for PFAS – Learnings from community events for high profile sites”
Date: Thursday 2nd March 2023
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Ruth Jarman (RACTRA)
ACTRA Webinar Series with Q&A – Session #25
Topic: “WA Guidelines and the Assessment of Asbestos Contaminated Sites”
Date: Thursday 2nd February 2023
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Pierina Otness
ACTRA Webinar Series with Q&A – Session #24
Topic: “Outdoor air pollution and cancer“
Date: Thursday 1st December 2022
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: John Frangos
ACTRA Webinar Series with Q&A – Session #23
Topic: “So many issues, so little time: the lost art of risk ranking”
Date: Thursday 20th October 2022
3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Victor Kabay
All Recordings from 2022 ACTRA ASM & CE Day
24-26 August 2022
Crowne Plaza Melbourne
Exposure Science and New Assessment Methods (NAMs)
Enhancing Risk Assessment
ACTRA Webinar Series with Q&A – Session #22
Topic: Ecological Risk Assessment Approaches
Date: Thursday 7th July 2022
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Katie Richardson
ACTRA Webinar Series with Q&A – Session #21
Topic: Human Health Risk Assessment Approaches
Date: Thursday 2nd June 2022
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Katie Richardson
ACTRA Webinar Series with Q&A – Session #20
Topic: Human Health Screening Approaches
Date: Thursday 5th May 2022
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Katie Richardson
ACTRA Webinar Series with Q&A – Session #19
Topic: Exposure Science tools and case studies (Session 2)
Date: Thursday 7 April 2022
Time: 3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Dr Len Turczynowicz
ACTRA Webinar Series with Q&A – Session #18
Topic: An introduction to Exposure Science (Session 1)
Date: Thursday 3 March 2022
Time: 3:00PM – 4:00PM AEDT (Melb/Syd time)
Presenter: Dr Len Turczynowicz
ACTRA Webinar Series with Q&A – Session #17
Topic: Risk assessment – Remember, Exposure is Important!
Thursday 4 November, 2021
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Dr Jackie Wright
ACTRA Webinar Series with Q&A – Session #16
Topic: The Chicken, the Egg and the Holy Grail – Serum PFAS Levels Following Access to Cholestyramine, Plasma Donation or a Combination of Cholestyramine and Plasma Donation
Thursday 7 October, 2021
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Dr Ian Delaere
ACTRA Webinar Series with Q&A – Session #15
Topic: Risk assessment of emerging contaminants – Theory and Practice
Thursday 9 September, 2021
3:00PM – 4:00PM AEST (Melb/Syd time)
Presenter: Victora Lazenby
ACTRA Webinar Series with Q&A – Session #14
Topic: An Introduction to Biomarkers of Lower Urinary Tract Toxicity Plus Case Study
Thursday 5 August, 2021
Presenter: Dr Rhian Cope
ACTRA Webinar Series with Q&A – Session #13
Topic: An Introduction to Biomarkers of Renal Toxicity Part 1
Thursday 1 July, 2021
Presenter: Dr Rhian Cope
ACTRA Webinar Series with Q&A – Session #12
Topic: An Introduction to Biomarkers of Hepatotoxicity Part 2
Thursday 3 June, 2021
Presenter: Dr Rhian Cope
ACTRA Webinar Series with Q&A – Session #11
Topic: An Introduction to Biomarkers of Hepatotoxicity Part 1
Thursday 6 May, 2021
Presenter: Dr Rhian Cope
ACTRA Webinar Series with Q&A – Session #10
Topic: Bioavailability – Case studies and worked examples
Thursday 8 April, 2021
Presenter: John Frangos
ACTRA Webinar Series with Q&A – Session #9
Topic: Key concepts of Bioavailability
Thursday 4 March, 2021
Presenter: John Frangos
ACTRA Webinar Series with Q&A – Session #8
Topic: Dose Response Assessment within standard setting and HHRA
Thursday 4 February, 2021
Presenter: John Frangos
ACTRA Webinar Series with Q&A – Session #7
Topic: Application of TTC in Risk Assessment
Thursday 3 December, 2020
Presenter: Roger Drew
ACTRA Webinar Series with Q&A – Session #6
Topic: History and Derivation of TTC Values
Thursday 5 November, 2020
Presenter: Roger Drew
ACTRA Webinar Series with Q&A – Session #5
Topic: Aspects of Risk Communication
Thursday 1 October, 2020
Presenter: Dr Peter N Di Marco
ACTRA Webinar Series with Q&A – Session #4
Topic: Principles of Human Health Risk Assessment
Thursday 3 September, 2020
Presenter: John Frangos
ACTRA Webinar Series with Q&A – Session #3
Topic: Environmental regulation and guidance
Thursday 6 August, 2020
Presenter: Professor Brian Priestly
ACTRA Webinar Series with Q&A – Session #2
Topic: Product based regulation
Thursday 9 July, 2020
Presenter: Professor Brian Priestly
ACTRA Webinar Series with Q&A – Session #1
Topic: Substance and/or process-based regulation
Thursday 11 June, 2020
Presenter: Professor Brian Priestly