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.

When
: 15-16 February 2022
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
  • 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

You can check out last year's course programme here 

Presenters

Past presenters included:

  • Hilary Gray, MTOPRA -Senior Manager, Regulatory Strategy, PRA Health Sciences UK Ltd.
  • Dr Dalna Harvey - Principal Consultant, Regulatory Measures Ltd
  • Joseph Irwin - Consulting Services, Lakeside Regulatory
  • Paul Browning - Associate Director, ConvaTec
  • Kathryn Brouder - Associate Director, BioMarin (Europe Ltd)
  • Missoune Bakhouche - Director, In Market Access Ltd
  • Marcello Menapace - Director, M&Ms Consulting Ltd
  • Melanie Pires - Pharmaceutical Assessor, 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: £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 meetings@topra.org 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%


Next steps

When
15/02/2022 - 16/02/2022
Where
ONLINE
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