Data requirements for Biocidal Products under Regulation (EU) No. 528/2012
|This webinar will provide you with a good understanding what data are needed to support the authorisation of biocidal products and biocidal product families under the BPR. The training will provide an overview of the data requirements, including:
– structure of the data requirements (core data set, additional data set)
– access to protected data
– avoidance of vertebrate testing
– possibilities for data waiving
– available guidance on conducting testing
– summary of the data requirements, section by section
– GLP requirements
– considerations for biocidal product families
extrapolation between formulations, minor changes
To ensure the most effective training with optimal involvement from the attendees, and encourage attendees to ask questions during the training, places are strictly limited to 30 delegates per webinar.
All registrants to the training webinar will receive a copy of all slides and access to a recording of the webinars for your personal review.
Dr. Irene McGrath
Irene studied Analytical Science at Dublin City University before completing a Ph.D. in Chemistry.
She has spent over 26 years managing Regulatory Departments and working as a consultant for the regulation of plant protection products, biocides, plant biostimulants and fertilisers in the EU. Irene manages the regulatory team of consultants at Kerona Scientific in Ireland, working with clients worldwide.
Catherine studied Analytical Chemistry and completed a Masters in Toxicology at Jordan University and has worked for over 12 years as a toxicology and chemistry consultant for the regulation of biocides, plant protection products and REACH in the EU and Middle East. Catherine is an expert in human health risk assessment, toxicology, classification and labelling and chemistry requirements for active substances and biocidal products, working with many different product types over the years.