Introduction to the Development and Licensing of Veterinary Novel Biotherapeutics in the EU

In this In-house course, discover how to develop veterinary pharmaceuticals and vaccines, its regulatory landscape and how you might apply these principles to novel biotherapeutics.

In-house Training and Consultancy Services

This In-house course will be essential for teams who need to know where to begin when looking to develop and license a veterinary novel biotherapeutic in the EU. The programme will provide a high level overview of the current, rather fluid situation on novel biotherapeutics and will leave delegates with a clear understanding of the present regulatory landscape and how to approach this type of product development in the EU.

The opportunities that novel biotherapeutics offer in the veterinary industry are becoming increasingly important in this competitive field and this In-house training programme will provide participants with a comprehensive insight as to how to maximise on this opportunity.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme

Types of Novel Biotherapeutics (Excluding Borderline Products e.g. Part Medical Device)

Approach for novel human therapeutics

  • Overview of current veterinary legislation & guidance (lack of)

Approach for veterinary pharmaceuticals

** Part 2,3,4 (high level)

Approach for veterinary vaccines

** Part 2,3,4 (high level)

Preparing development plans for veterinary novel biotherapeutics

** scientifically justified approach
** risk-based
** consideration of relevance of human GLs

Incentives

  • for SMEs
  • MUMS (limited market products)

How to improve regulatory certainty

  • update of Vet Med Reg
  • contact discuss with regulators
  • ITF
  • Scientific advice
  • ADVENT

Routes to market

Recommended trainer

Juliet Greenslade

Juliet Greenslade has over 16 years experience working in the Animal Health Industry and holds degrees in Immunology and Medical Microbiology. She started her career as a Medical Microbiologist in a large teaching hospital (5 years) before moving into the Animal Health arena. Before moving into Regulatory Affairs Juliet worked as a Scientist and GLP study Director in Biologicals R&D at Intervet. Later on she joined Schering-Plough as a Senior Regulatory Manager and then Pfizer (now Zoetis) as an Associate Director. During her work in “big pharma”, she took responsibility for developing and registering new products, life-cycle maintenance of existing products and advising on regulatory strategy. In her current role as Project Manager, Biologicals Regulatory Affairs, at Triveritas, Juliet assists clients (large and small) in a variety of areas, from advising on regulatory strategy and product development, through to preparing Expert Reports, writing Dossiers and running regulatory procedures on behalf of clients.