Efficacy Workshop: How to Build a Solid Case

Ever had a problem with your efficacy? Have you been at loggerheads with the evaluating member states about the acceptability of your efficacy trials? Or have they questioned the activity of your co-formulants. Are you looking for the solution?

We are pleased to offer you a one day training, which gives an in-depth overview about the efficacy assessment of biocidal products within the framework of the Biocidal products regulation (EU) 528/2012) (BPR).

Participants will gain comprehensive information on the different product types (PTs), the specific requirements and challenges and learn about the most important guidance documents that are required for efficacy assessment. An introduction to the practical implementation of the guidance and norms during dossier preparation will be given and will include strategy development, the possibility of worst-case testing and bridging as well as the requirements for co-formulant testing.

Last but not least, you will have the chance to gain insight knowledge about efficacy testing and the impact of BPR on biocidal products and their development from the perspective of a well-established, experienced and accredited microbiological testing laboratory.

This training will offer the opportunity to address all your open questions to an expert panel.

Content

  • General introduction into Efficacy for active substances and biocidal products
  • Overview over the most important documents and their development
  • Addressing Efficacy in PAR and IUCLID and challenges for different PT main groups
  • Disinfectants vs. Preservatives
  • New guidance for PT5 & PT11/12
  • Strategies for efficacy testing  for biocidal product families, worst case testing, bridging and impact on budget and label
  • Experiences, challenges and resources for the testing of biocidal product families from the laboratory point of view
Details
Note: 
New!
Target audience: 
R&D Manager, Regulatory Specialists and Portfolio Manager
Participants: 
approx. 16
Language: 
English
0