Appropriate clinical trial design: Fixed cocktail or magistral phage? What is regulatory guidance within Europe, including the current barriers & working solutions
Dr Pieter-Jan Ceyssens, Unit Head ‘Antibiotics & Resistance’, Sciensano
Eric Pelfrene, Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division, EMA
Nathalie Morgensztejn, Head of Virology and Gene Therapy Department, ANSM
- Discover the European regulatory bodies’ position on both approaches in phage therapy.
- Asses the possibilities for regulatory protocols currently in place within present European countries administering phage therapy.
- Debate the benefits and challenges of each model for achieving clinical data.