CRED Compiling Successful Clinical Trial Applications

CRED Compiling Successful Clinical Trial Applications
This workshop based course will equip you with the key regulatory knowledge on Clinical Trials


When: 14 - 15 November 2018 
Where: TOPRA, 3 Harbour Exchange, South Quay, London, E14 9GE
Start time (Day 1) - 09:00
End time (Day 2) - 16:30


What is it?
A two-day course looking at the current requirements for an EU Clinical Trial Application (CTA), as well as some of the requirements in key countries outside the EU. It will also include information on strategic considerations for CTAs and clinical development, and will on touch on special cases such as first in man studies and paediatrics. 

The new EU Clinical Trials Regulations will be reviewed, including some of the key changes that we might expect to see as a result of this. A Regulatory Agency speaker has been invited to give their perspective on common issues and hot topics associated with CTAs. 

 

Who is it for?
This course is suitable for:
  • Less experienced Regulatory Professionals who require comprehensive information on a subject. 
  • Experienced professionals who is a newcomer to a particular regulatory aspect.
  • Anyone who wishes to update their knowledge in a particular subject area.  

 

What will I learn?
The course will cover an overview of the EU CTA and the IMPD dossier and how to maintain your CTA, the Voluntary Harmonisation procedure, the new Clinical Trial Regulation and a case study workshop to reinforce the lectures. 

Download the course programme

CPD: 14.5

 

Presenters

Shaila Choi
Shaila Choi
Independent consultant 
 		 Jo Hulbert
Jo Hulbert
PRA Health Sciences
  		Chris Parkinson
 Chris Parkinson
GSK
Matt Scullion
Matt Scullion
Janssen		 Stephen Thompson
Stephen Thompson
S-cubed 		  

 

How do I register? 
Simply log in or create an account and register below. 

Course fees:
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 are in full-time education
  £462.50+VAT
  £547.50+VAT

 

Terms and conditions 
By booking a place on this course you are agreeing to the training terms and conditions.
When
14/11/2018 - 15/11/2018
Where
TOPRA Ltd 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Online registration not available.
My registration status: Not registered
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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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