Regulatory and Technical boundaries for phage therapy and FMT in animals

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RTDS Group - Research to market

How regulatory and technical issues burden the use of phage therapy and FMT for the control of infectious diseases in veterinary medicine

Festeauditoriet

Join us on 17 October to discuss the regulatory and technical issues hindering the development and use of phage therapy and faecal microbiota transplantation (FMT) in animals. The aim of the workshop is to bring together scientists, industry and regulatory agencies for a constructive discussion to overcome the regulatory and technical barriers and facilitate the approval and the market uptake of these alternatives to antimicrobials PROGRAMMESESSION ON PHAGE THERAPY09.00-09:10: Welcome by the AVANT coordinator, Luca Guardabassi, UCPH, Denmark09.10-09:30: Challenges in developing a phage-based product against enterotoxigenic E. coli in pigs, Michela Gambino, UCPH, Denmark09.30-10.00: Challenges in manufacturing phage-based products: the industry perspective, Frenk Smrekar, JAFRAL, Slovenia10.00-10.30: Regulatory requirements for the authorisation of veterinary medicinal phage products, Javier Pozo Gonzalez, EMA10.30-10.45: Kahoot quiz on phage therapy (download Kahoot <a href="https://apps.apple.com/us/app/kahoot-play-create-quizzes/id1131203560" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">here</a>)10.45-11.15: Coffee break11.15-12.00: Roundtable discussion with the speakers and and representatives from the Danish Medicines Agency (Lotte Dahl and Martin Bronislaw Oleksiewicz), chaired by Klaus Helmann, KLIFOVET, Germany12.00-13.00: Lunch breakSESSION ON FAECAL MICROBIOTA TRANSPLANTATION (FMT)13.00-13:15: Challenges in developing a FMT protocol to prevent post-weaning diarrhoea in pigs, Thomas Thymann, UCPH, Denmark13.15-13.30: FMT in hospitals: what can we learn from our colleagues in human medicine? Maria Vehreschild, Cologne University Hospital, Germany (online pre-recorded)13.30-13.45: Use of FMT for control of viral diseases of swine, Megan Niederwerder, Kansas State University, USA (online pre-recorded)13.45-14.05: Current regulatory challenges in the development of microbiome products, Mirja Huhtinen, Orion Pharma, Finland14.05-14.20: Bacteriotherapy in healthy suckling piglets: success parameters to consider, Alexandre Thibodeau, University of Montreal, Canada (online live)14.20-14.30: Kahoot quiz on FMT (download Kahoot <a href="https://apps.apple.com/us/app/kahoot-play-create-quizzes/id1131203560" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">here</a>)14.30-15.00: Coffee break	15.00-15.45: Roundtable discussion with the speakers and representatives from the Danish Medicines Agency (Lotte Dahl and Martin Bronislaw Oleksiewicz), chaired by Klaus Helmann, KLIFOVET, Germany15.45-16.00: Wrap-up conclusions and meeting closure, Luca Guardabassi, UCPH, Denmark

Regulatory and Technical boundaries for phage therapy and FMT in animals

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Regulatory and Technical boundaries for phage therapy and FMT in animals

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