CRED Regulatory Document Writing and Management

CRED Regulatory Document Writing and Management
Given the importance of successful regulatory submissions this course is a must as we discuss the best way to prepare pharmaceutical and device submissions. This course course is a skills based course on the theory and practice of writing regulatory documents and communications for optimal impact and effectiveness.

When: 19- 20 March 2024
Location: Online
Day 1: 09.00 - 16.45 | Day 2: 09.00 - 17.00

Also available as a face to face course, please click here for the face to face 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
  • 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

See course programme here 

Presenters

Presenters:

  • Hilary Gray, MTOPRA -Director  (GRAS) - Syneos Health
  • Dr Dalna Harvey - Principal Consultant, Pfizer
  • Joseph Irwin - Consulting Services, XO Forte
  • Paul Browning - Associate Director, ConvaTec
  • Kathryn Brouder - Associate Director, BioMarin (Europe Ltd)
  • Kelly Smith -  Senior Manager, Medical Writing, Certara
  • Obaid Khan - Johnson & Johnson
  • Duncan Arbour - Syneos Heaith
  • Abigail Moran - MHRA

Suitable for

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

Pricing  

Standard

  • Member: £955 + VAT
  • Non-member: £1,130+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.

Discounted prices

  • Those working for regulatory agencies, government agencies or academic institutions
    • Members: £716.25+ VAT
    • Non-members: £847.50 + VAT
    • Those working for charities, patient groups or in full-time education
    • Members: £477.50+VAT
    • Non-members: £565+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
When
19/03/2024 - 20/03/2024
Where
ONLINE
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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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