Overview

This workshop will be delivered over three half day sessions and will provide an overview of efficacy trial design and trials reports, and how to critically assess and present data in a Biological Assessment Dossier (BAD) for plant protection products (PPP’s). The outcomes are also to develop an understanding of how the data support the proposed GAP and GB & NI National labels for product authorisations. The workshop will focus on providing delegates with the opportunity of discussing and working on data examples that address the regulatory requirements for submissions of a BAD document. This hands-on workshop will help attendees improve their preparation of Biological Assessment Dossiers (BADs) by clarifying regulatory expectations, addressing common challenges, and showcasing best practices.

Topics covered

The following topics will be covered:

• Hands-on exploration of data examples (approximately 80% of time)
• Effective trials programs and trials reports
• Assessment and presentation of data
• Data interpretation, Good Agricultural Practice (GAP) and label claims
• Common errors and problems
• Regulator perspective
• Open format – we encourage discussion
• Group working discussion of applicant questions

View or download the full event programme here.

Who should attend?

This course is suitable for those involved in designing and conducting efficacy trials, assessing trials data, and writing efficacy BADs and draft registration reports for submission to regulatory authorities. No prior experience in this area is assumed, and the course is suitable for beginners as well as more experienced BAD writers. The primary focus of this workshop is the use of practical realistic examples to help attendees understand how regulators review the BAD and associated draft Registration Report, and how to effectively meet regulatory requirements.

Attendees should be familiar with 1107/2009 efficacy data requirements, associated EPPO standards, and the regulatory framework, as these will not be covered in detail in this workshop.