The presentation and interpretation of Efficacy trials data in Biological Assessment Dossiers to support authorisations of Plant Protection products in accordance with EC 1107/2009 (as it has effect in GB/NI) 14, 15 & 16 December 2021 This workshop sessions will be delivered over three half day sessions and 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 PPPs. The outcomes are also to develop an understanding of how the data supports the proposed GAP and GB & NI National labels for product authorisations. The workshop will focus on providing delegates with the opportunity to discuss and work on data examples that address the regulatory requirements for submissions of a BAD document. This largely practical workshop will help attendees improve their BAD writing by understanding the regulatory approach, common problems, and identifying best practice. Time will be available during the workshop for some group discussion of specific applicant questions relating to their own data. 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. Topics covered - Hands-on exploration of data examples (approximately 80% of time)
- Effective trials programs and trials reports
- Assessment and presentation of data
- Data interpretation and GAP and label claims
- Common errors and problems
- Regulator perspective
- Open format – we encourage discussion
- Group working discussion of applicant questions
Registration To register for this fee paid workshop please visit this page. The closing date for registration is 6 December 2021. | 
No comments:
Post a Comment