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, 3 Harbour Exchange, 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 15 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


 
  

 
Andrew Thornley
AESGP 		  Hilary Gray
Indivior UK  		  Joseph Irwin
Lakeside Regulatory
Consulting Services

 Melanie Piers
MHRA 
         
Patricia Colin
MDSSPRO		 Paul Browning 
3M		 Tacye Connolly 
Wishanger		    









Suitable for

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

Pricing  

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
Registration not available.
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NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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