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2020 Animal Health

Aseptic Animal Health

Oct 20 - Oct 21, 2020
The Hague, The Netherlands

  • Conference
  • Europe

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Program Highlights

Representatives from the United States Food and Drug Administration, the European Medicines Agency and the Dutch Medicines Evaluation Board have been invited 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 and discuss the revised Annex 1.

Check out the agenda preview today!

Overview

Dear Colleagues,

In the name of the Program Planning Committee, please be warmly invited to join the inaugural PDA Europe Aseptic Animal Health Conference!

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 not only on on challenges associated with the implementation of the new Veterinary Medicines Regulation but also on the the revised Annex 1. 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 Considerations for Global Aseptic Manufacture.

Be sure to join us in The Hague this October!

Sincerely,

The Chair

Mai X. Huynh, 
U.S. FDA

Agenda

  • Day 1
  • Day 2
  • Tuesday, 20 October 2020

    9:00
    Welcome and Introduction

    Falk Klar, PDA Europe

    Keynote: Updates in the Regulatory Landscape

    Luc Pisarik, Boehringer Ingelheim

    Opening Plenary: Updates in the Regulatory Landscape
    Moderator: Corma Otte, Dutch Veterinary Medicines Agency

    Regulatory Updates from EMA – Human vs. Animal Health
    EMA

    The Implementation of the New Veterinary Medicines Regulation
    Dutch Medicines Evaluation Board

    10:50 - 11:20
    Coffee Break, Poster Session & Exhibition

    Regulatory Updates to the Mutual Recognition Agreement
    US FDA, Dutch Inspectorate

    How to Mitigate Drug Shortages by Managing Supply Chain Complexity
    Speaker invited

    Panel Discussion

    13:00 - 14:00
    Lunch Break, Poster Session & Exhibition

    Session 1: Quality and Data Intergity
    Moderator: Stacey Vaughan,
    WEST

    Latest Updates and the Future Vision of VICH Quality Guidelines and a Comparison to ICH
    Mai Huynh, US FDA
    Federal Office of Consumer Protection and Food Safety, Germany

    PDA Activities and Updates – New Technical Report on Data Integrity and Manufacturing
    PDA Task Force

    Q&A, Discussion

    15:30 - 16:00
    Coffee Break, Poster Session & Exhibition

    Session 2: Aseptic Manufacuring
    Moderator: Alexander Trautmann,
    Consultant

    Revised Annex 1 and the Impact on the Manufacture of Animal Health Products
    MHRA

    Overview of the Fundamental Principles Governing Aseptic Processing
    Ceva Santé Animale

    Restricted Access Barrier Systems vs. Isolator – Status Quo and a Look into the Future
    Syntegon Packaging Technology

    Q&A, Discussion

    18:00
    End of Conference Day 1 & Networking Reception

  • Wednesday, 21 October 2020

    Session 3: Developing Animal Vaccines
    Moderator: Anissa Boumlic
    , Merck KGaA

    9:00
    K. Lactis Yeast-Based Inactivated Subunit Vaccines for Animal Health
    VeroVaccines

    Filtration Strategies for Optimal Development and Purification of a Foot and Mouth Disease Vaccine Produced In BHK21 Cells
    Merck KGaA

    Q&A, Discussion

    10:30 - 11:00
    Coffee Break, Poster Session & Exhibition

    Session 4: Technical Aspects of Global Manufacture
    Moderator: Martin Muellner,
    Boeheringer Ingelheim

    Advantages of Single Use Systems
    Speaker invited

    Study of Contaminated WFI in China: Impact of the Design, Periodic Maintenance ant the Risk of False Negative
    Olivier Chancel, Boehringer Ingelheim

    Q&A, Discussion

    12:30 - 13:30
    Lunch Break, Poster Session & Exhibition

    Closing Plenary: The Furture of Veterinary Manufacture
    Moderators:

    Luc Pisarik, Boehringer Ingelheim
    Olivier Chancel,
    Boehringer Ingelheim

    Mentimeter Live Polling: What challenges does the Animal Health Industry anticipate in the future?

    VICH – Successes and Future Challenges
    VICH

    14:45 - 15:15
    Coffee Break, Poster Session & Exhibition

    Manufacturing Innovations in Animal Health
    Speaker invited

    Closing Panel Discussion & Review of Results of Live Polling

    Conference Summary

    16:30
    Closing Remarks and Farewell

    Falk Klar, PDA Europe

    16:30
    End of Conference Day 2

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

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Travel

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Leonardo Royal Hotel Den Haag-Promenade

Van Stolkweg 1
The Hague, The Netherlands
Phone: +31-70-3525161

Leonardo Royal Hotel Den Haag-Promenade
  • Accommodations

    Hotel Website

    This 5-star hotel is located with-in a 5 minute drive from Schevening Beach and a 10-minute drive to the centre of The Hague. Leonardo Royal Hotel Den Haag-Promenade offers free WiFi, a spa and wellness centre and an indoor heated swimming pool. Guests can benefit from the 24-hour breakfast service. Each modern room is air-conditioned.They feature a desk, seating area, minibar and flat-screen TV. All bathrooms are fitted with a shower, some of the rooms feature a bath.

    Breakfast is offered each morning in the restaurant or in your room. In the evenings a French and Mediterranean cuisine is served. The bar provides a wide range of drinks including cocktails. Crowne Plaza features a fitness centre, sauna, steam bath and massages. There is a 24-hour front desk and laundry and dry cleaning services are available.

    PDA Europe has reserved a limited number of rooms until the 20th August 2020
    Single Superior Room € 155 per night*
    Double Superior Room € 174 per night*

    *Rates are per room and night, including the following services and benefits:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Rotterdam The Hague Airport - RTM
Airport Phone:
+31 10 446 3444

By Car

 The Hague Central Station and the A12 highway are 4 km away.

Other Options

The centre of The Hague is also easy accessible by tram.
Find more information here!

Directions

Registration Fees

Early Registration
Registration Type Price by 30 August
Member €1.595
Non-member €1.895
Poster-Presenter Member €1.645
Poster-Presenter Non-member €1.945
Govern./Health Authority/Academic €700
Young Professional (Member) €700
Regular Registration
Registration Type Price after 30 August
Member €1.795
Non-member €2.095
Poster-Presenter Member €1.845
Poster-Presenter Non-member €2.145
Govern./Health Authority/Academic €900
Young Professional (Member) €900
All fees given in Euro, excluding VAT (21%)

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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