HSL is to run a 2 day course on CRD -Two Day Efficacy Workshop: The presentation and interpretation of Efficacy trials data in Biological Assessment Dossiers to support authorisations under EC 1107/2009.
The Chemicals Regulation Division, Mallard House, Kings Pool, 3
Peasholme Green, York YO1 7PX
10-11 January 2018
This two day workshop will provide an overview of the importance
of efficacy trial design and trials reports, how to approach and
critically assess data, and effective presentation of data in a
Biological Assessment Dossier (BAD). The outcomes are also to
develop an understanding of how the data support the proposed GAP
and National labels for product authorisations. This largely
practical workshop will use data examples to 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.
The course will cover:
- Worked examples and practical sessions (approximately 80% of
- The importance of effective trials design and trial
- Collation and critical assessment of trials data
- Principles of data presentation in the BAD
- Examples of effective and flawed approaches
- Common errors and problems
- Use of the BAD to devise and support dRRs, GAPs, and National
- Group discussion of applicant questions (details of question
scope and how to submit questions will be provided after course
Download the programme for the day here
Given the nature of the workshop,
places will be limited to a maximum of 16
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 dRR, and
how to effectively meet regulatory requirements. However, 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. This course
may be of interest to previous attendees of the companion efficacy
workshop 'Requirements and Assessment under EC
The workshop will be held at The Chemicals Regulation Division,
Mallard House, Kings Pool, 3 Peasholme Green, York YO1 7PX.
Registration will begin from 9:15 am. The workshop will start at
9:45 am on day one and finish around 4:00 pm on day two.
The cost of this course is £650 (plus VAT) per person (includes
course notes, lunch and refreshments)
Please note the invoice option is not available within 4
weeks of the course date, or for overseas customers. If you
are selecting the invoice option for payment, it will be mandatory
to input a purchase order/reference number as we are unable to
process booking forms without this.
For further dates and additional information email: firstname.lastname@example.org
or contact the Training & Conferences Unit
at HSL directly on +44 (0)1298 218806.
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