PDA Europe Virtual Conference - Aseptic Animal Health
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Program Highlights
Representatives from the United States Food and Drug Administration and the Dutch Medicines Evaluation Board will join the online event to share their views on challenges associated with the implementation of the new Veterinary Medicines Regulation, and their expert insights on the Mutual Recognition Agreement between US and Europe. The distinguished program also will include an update from the VICH Quality Expert Working Group.
To complement the exciting presentations from the regulatory realm, industry experts will will provide insights into recent innovations and technical specifics of manufacture of veterinary health products, including Animal Vaccines.
Check out the agenda today and be sure to join us online!
Dear Colleagues,
In the name of the Program Planning Committee, please be warmly invited to join the inaugural PDA Europe Virtual Conference Aseptic Animal Health!
Manufacturers of products for veterinary use face specific challenges. Due to lower product prices compared to human pharma products, it is crucial that cost efficiency is considered in the design of manufacturing processes. The GxP regulations for animal health products today are nearly as strict as we know from human pharma. Also, veterinary products need to be available for a large number of different species.
The EU has officially adopted a new legislation on veterinary medicines applicable in all EU countries from 28 January 2022. The new regulation brings significant changes to the way animal medicines are regulated in the market authorization process but also in manufacturing, distribution, retail and controls. These changes are considered to stimulate innovation and to improve the availability of animal medicines. Another main area of the new regulation is to address public health risks arising from antibiotic resistance.
Regulatory representatives and industry experts will join discussions on challenges associated with the implementation of the new Veterinary Medicines Regulation. Attendees will also hear their expert insights on the Mutual Recognition Agreement between US and Europe.
Relevant topics such as Animal Vaccines and advanced therapies for livestock but also companion animals will be complemented by sessions focusing on Quality & Data Integrity or Technical Aspects of Veterinary Manufacture.
Be sure to join us this October!
Sincerely,
The Chair
Mai X. Huynh,
U.S. FDA
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Standard Registration
GovernmentMember Only
€ 645
Health AuthorityMember Only
€ 645
AcademicMember Only
€ 645
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Tuesday, 20 October 2020
Module I: Opening & Updates in the Regulatory Landscape
13:00-15:30 CEST
Welcome and Introductions |
Falk Klar, |
Welcome by the Chair |
Mai X. Huynh, |
Keynote: Human and Animal Health – Similarities and Differences |
Luc Pisarik, Boehringer Ingelheim Animal Health |
Break and Virtual Exhibition
13:30 - 14:00 CEST
Updates in the Regulatory Landscape | Moderators: Mai X. Huynh, U.S. FDA Luc Pisarik, Boehringer Ingelheim |
The Implementation of the New Veterinary Medicines Regulation | Frank Verheijen, Dutch Medicines Evaluation Board |
Regulatory Updates to the Mutual Recognition Agreement | Susan Laska, U.S. FDA |
How Managing Supply Chain Complexity Can Help to Mitigate Drug Shortages | Michael Schousboe, Novo Nordisk |
Live Q & A, Discussion |
Break and Virtual Exhibition
15:30 - 16:30 CEST
Module II: Developing Animal Vaccines
16:30-18:00 CEST
Developing Animal Vaccines |
Moderators: |
K. Lactis Yeast-Based Inactivated Subunit Vaccines for Animal Health | Hanjo Hennemann, VeroVaccines |
Filtration Strategies for Optimal Development and Purification of a Foot and Mouth Disease Vaccine Produced in BHK21 Cells | Youness Cherradi, Merck KGaA |
Live Q & A, Discussion |
Virtual Networking Event
18:00 - 19:00 CEST
Meet Your Peers in Our Networking Lounges | |
Lounge I | Meet the Regulators |
Lounge II | Delve Deeper into the Discussions of the Day |
Day 2
Wednesday, 21 October 2020
Module III: Updates on Quality Guidelines and Modern Practices in Data Integrity & Aseptic Manufacture
12:00-14:40 CEST
Updates on Quality Guidelines and Modern Practices in Data Integrity & Aseptic Manufacture | Moderators: Stacey Vaughan, WEST Alexander Trautmann, A&O Pharmadienstleistungen |
Comparison of ICH and VICH Quality Guidelines | Anja Pfalzgraff, Federal Office of Consumer Protection and Food Safety Germany |
The Future Vision of the of VICH Quality Guidelines | Mai Huynh, U.S. FDA |
PDA Technical Report on Data Integrity in Manufacturing | Anne Pericone, J&J |
Break and Virtual Exhibition
Approaches for Sterile Process Validation | Renée Blosser, U.S. FDA |
Restricted Access Barrier Systems vs. Isolator – Status Quo and a Look into the Future | Matthias Angelmaier, Syntegon Packaging Technology |
Live Q & A, Discussion |
Break and Virtual Exhibition
14:40-15:30 CEST
Module IV: Technical Aspects of Veterinary Manufacture and an Outlook to the Future
15:30-18:00 CEST
Technical Aspects of Veterinary Manufacture and an Outlook to the Future |
Moderators: |
Case Study of Contaminated WFI in China: Impact of the Design, Periodic Maintenance ant the Risk of False Negatives | Olivier Chancel, Boehringer Ingelheim |
Manufacturing Innovations using Robotics in Aseptic Processing Environments | Shannon Burton, Union Agener |
Break and Virtual Exhibition
Addressing Challenges of Technology Transfer in Animal Health | Rebecca Welton, Lachman Consultants |
VICH – Successes and Future Challenges | Herve Marion, VICH |
Live Q & A, Discussion |
|
Conference Summary and Farewell |
Mai X. Huynh, U.S. FDA |
Closing: Chair Awards, Outlook and Farewell | Falk Klar, PDA Europe |
Details subject to change without notice
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