CRED Practical Document Writing and Management

CRED Practical Document Writing and Management
A two-day, skills-based course on the theory and practice of writing optimal regulatory documents and communications for those working in the pharmaceutical industry.

When: 19-20 February 2020 
Where: TOPRA, 3 Harbour Exchange, London, E14 9GE
Day 1: 09.00 - 16.45 | Day 2: 09.00 - 17.00 (GMT)

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
  • What everyone needs to know about writing regulatory communications and overviews 
  • 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

Download a copy of the programme here.

Presenters

Paul Browning  Paul Browning, FTOPRA 
Clinical, Regulatory and Reimbursement Manager
3M UK
Hilary Gray  Hilary Gray, MTOPRA
Senior Manager, Regulatory Strategy
Indivior
Dalna Harvey  Dr Dalna Harvey 
Principal Consultant
Regulatory Measures Ltd
  Dr Ben Rackstraw
Senior Pharmaceutical Assessor
Medicines and Healthcare products Regulatory Agency - UK 
Andy Thornley  Dr Andy Thornley, MTOPRA 
Consulting Partner, Regulink
Regulatory Affairs Consultant/Advisor, FMD K&L 

Suitable for

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

Register

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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 20%

Terms and conditions

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

Next steps
When
19/02/2020 - 20/02/2020
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Your company name
Your VAT country
Your VAT number
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

Register now