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CRD -Two Day Efficacy Workshop: The presentation and interpretation of Efficacy trials data in Biological Assessment Dossiers to support authorisations under EC 1107/2009

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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

21 - 22 March 2018

Introduction

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 time)
  • The importance of effective trials design and trial reports
  • 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 product labels
  • Group discussion of applicant questions (details of question scope and how to submit questions will be provided after course sign-up)

Download the programme for the day here

Given the nature of the workshop, places will be limited to a maximum of 16 delegates.

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 1107/2009'.

Venue

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.

Cost

The cost of this course is £650 (plus VAT) per person (includes course notes, lunch and refreshments)

Book Course

 

 

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: training@hsl.gsi.gov.uk or contact the Training & Conferences Unit
at HSL directly on +44 (0)203 028 3704.

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Contact Details

HSL Training & Conferences Unit
Harpur Hill
Buxton, Derbyshire
SK17 9JN

E: training@hsl.gsi.gov.uk
T: +44 (0)203 028 3704