CRED Regulatory Document Writing and Management

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

: 25-26 April 2023
Where:  TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom 
Start time day 1: 09.00 BST |End time day 2 : 16.30 BST

Also available as an online course, please click here for the online registration option.

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.


Download a copy of the programme  here 


Presenters Include:

  • Hilary Gray, MTOPRA -Director Regulatory Consulting, Syneos Health
  • Dr Dalna Harvey - Regulatory Submission Technical Writer, Pfizer
  • Joseph Irwin - Consulting Services, LRCS Ltd
  • Paul Browning - Associate Director, ConvaTec
  • Kathryn Brouder - Associate Director, BioMarin (Europe Ltd)
  • Julian Beach - MHRA
  • Obaid Khan - Johnson & Johnson
  • Kelly Smith -  Senior Manager, Medical Writing, Certara

Suitable for

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



  • Member: £925 + VAT
  • Non-member: £1,095+VAT

Discounted places

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

Discounted prices

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

* VAT, if applicable is charged at the rate of 20%

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions

Next steps

25/04/2023 09:00 - 26/04/2023 17:00
Sign in or create an account to register
My registration status: Not registered
Your company name
Your VAT country
Your VAT number
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

Register now