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

Agenda

Discover What's Happening Each Day
Day 1 20 Oct Day 2 21 Oct
Tuesday, 20 October

Tuesday, 20 October 2020

Module I: Opening & Updates in the Regulatory Landscape
13:00-15:30 CEST

The new Veterinary Medicines Regulation (Regulation (EU) 2019/6) will modernize the existing rules on the authorization and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022. Key benefits of the regulation include increased availability and access to safe and high-quality medicines for veterinarians, farmers and pet owners to treat and prevent animal diseases; reduced administrative burden and better incentives for pharmaceutical companies developing new and innovative veterinary medicines, benefiting in particular micro, small and medium-sized enterprises (SMEs); and new and enhanced rules to keep antimicrobials (including antibiotics) effective based on a 'One health' approach for the benefit of animal and public health and every EU citizen.

Welcome and Introductions

Falk Klar,
PDA Europe

Welcome by the Chair

Mai X. Huynh,
U.S. FDA 

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:
Anissa Boumlic, Merck KGaA

Olivier Chancel, Boehringer Ingelheim
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
Wednesday, 21 October

Wednesday, 21 October 2020

Module III: Updates on Quality Guidelines and Modern Practices in Data Integrity & Aseptic Manufacture
12:00-14:40 CEST

In an effort to keep attendees up to date, this session will address updates on the quality and regulatory topics.  Regulators from Germany and the United States will share expectations on the evolution of VICH Quality Guidelines and how they compare to ICH. An update on PDA’s new Technical Report on Data-integrity and Manufacturing will round out the session.
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

This session is oriented towards future of Animal Health manufacture. Hot topics around Animal Health Guidance will be discussed by leading experts from the industry. Insights into current and new technologies are given that are driving the future of manufacturing in Animal Health. It also gives a broad overview of real-time approaches, rapid microbiology methods, robotic updates with a specific focus on continuous manufacturing. Attendees will have the opportunity to participate in a live survey through an interactive session addressing current topics, expectations about future challenges and visions on future concerns and trends. What will the future of specific AH Guidance be, how will they evolve, will they keep their specificities? How will new technologies enable more flexibility in the pharmaceutical industry? Will robotics be the entry point for continuous manufacturing? Finally, this session will include a conference summary, outlining the most important take-home messages.

Technical Aspects of Veterinary Manufacture and an Outlook to the Future

Moderators:
Martin Muellner, Boehringer Ingelheim

Luc Pisarik, Boehringer Ingelheim

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
Luc Pisarik, Boehringer Ingelheim
Olivier Chancel, Boehringer Ingelheim
Closing: Chair Awards, Outlook and Farewell Falk Klar, PDA Europe

Details subject to change without notice

Registration

Pricing Options

More information coming soon.

Standard Registration

GovernmentMember Only

€ 645

Health AuthorityMember Only

€ 645

AcademicMember Only

€ 645

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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