CRD - Live Online Efficacy Workshop: The presentation and interpretation of Efficacy trials data in Biological Assessment Dossiers to support authorisations of Plant Protection products (PPP)
Live Online
18th, 19th and 20th October 2022
Introduction
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 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 largely practical workshop will help attendees
improve their BAD writing by understanding the regulatory approach,
common problems, and identifying best practice.
The course will cover:
- 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
Download the programme for the day 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.
Live Online Course Information
All you will need is an internet-connected computer,
laptop or tablet, plus a webcam and microphone. We do not recommend
using a smartphone. Before you book, please check that you meet
the
Zoom System Requirements and run a diagnostic test to ensure the
software is compatible with your firewall settings. If this does
not work, try adjusting your settings or contact your IT department
about permitting the website.
Cost
The cost of this course is £670 (plus VAT) per
person.
Please note that all courses must be paid for via credit
card at the time of booking.
Some of our training courses can also be delivered
in-company, please contact us to discuss your requirements.
Email: HSEtraining@hse.gov.uk
Telephone: +44 (0)203 028 3704
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