Regulatory Document Writing and Management

Regulatory Document Writing and Management
Skills based course on the theory and practice of writing regulatory documents and communications for optimal impact and effectiveness.

When
: 20-21 March 2019
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Day 1: 09.00 - 16.45
Day 2: 09.00 - 17.00



Course overview

This course will look at the theory and practice of writing clear and precise regulatory documents and communications including:
  • The importance of good writing, language and style
  • How to organise/build a document
  • Managing a dossier and the process from data to submission
  • Managing teams, peers and disagreements
  • What everyone needs to know about writing regulatory communications and overviews
  • Writing technical reports
  • Expert tips for authors using Word
  • Hints and tips from a regulatory authority

Benefits to delegates

  • Meet and learn from experts in the field
  • Learn by doing - participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • Develop skills to increase performance and support career progression 
  • Learn to write and construct regulatory submission documents 
  • Get fewer corrections from your colleagues and enhance your reputation for good work
  • Get through internal review faster
  • Minimise questions from regulators
  • Take a course designed by professionals for professionals with a proven track record
CPD: This course provides 7.5 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Programme

The latest course programme can be downloaded here.

Presenters


 


 
 Hilary Gray
Indivior UK Ltd
 Joseph Irwin
Lakeside Regulatory
Consulting Services LTD
Kathryn Brouder
BioMarin Europe Ltd








Suitable for

  • Regulatory Affairs Professionals writing reports and dossier sections
  • Related technical experts who write regulatory documents 

Pricing  

Book now at 2018 registration fees! 

Type Member Non-member 
Standard    £925+VAT  £1,095+VAT

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.

 
Those working for regulatory agencies, government agencies or academic institutions 
 £693.75+VAT
 £821.25+VAT
Those working for charities, patient groups or in full-time education
 £462.50+VAT  £547.50+VAT

*VAT, if applicable, is charged at the rate of 21%

Next steps

When
20/03/2019 - 21/03/2019
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Your VAT country
Your Vat number
NOTE
If your company VAT number does not appear here or you would like to be invoiced using a different VAT number please email finance@topra.org

Register now

Our policy on photography and video

On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

However, if for any reason you do not wish TOPRA to use your image or voice please let us know

Recording and photography by delegates is not permitted.