TOPRA in Scotland Meeting - CTR Transitions

TOPRA in Scotland Meeting - CTR Transitions
TOPRA in Scotland would like to invite members and non-members to a presentation on CTR Transitions.






Registration is now open for the next TOPRA in Scotland meeting, which will be held in-person.

Date: Wednesday 13 March 2024

Time: 14.00-17:00 GMT

Venue: The Sir Arthur Conan Doyle Centre, 25 Palmerston Place, Edinburgh, EH12 5AP.

Please note that this meeting will be in-person only and not be held as an open webinar. Light refreshments will be provided. 

On 31 January 2022 the Clinical Trial Regulation [Regulation (EU) No. 536/2014] repealed the Clinical Trials Directive [Directive (EC) No. 2001/20/EC] and all national implementing legislation from the statute books and began the transition phase for clinical trials.  The next major milestone came during January 2023 when all initial clinical trial applications had to be filed through the Clinical Trials Information System (CTIS).  As we now enter the final phase of transition for all existing clinical trials, scheduled to be completed on 31 January 2025, the TOPRA In Scotland Steering Committee decided that this is the optimal moment to revisit our earlier CTR conversation and dive deeply into "CTR Transitions".
 
Our expert guest speakers will address what has changed in EU CTR since the beginning and how we have adapted, how best to manage speciality clinical trials under the regulation, and provide comprehensive and in-depth updates on the challenges around CTR transitions and how we can best manage these as regulatory professionals.
 
SPEAKERS 
 
Katy Hunter 
Katy Hunter is a Director within ICON's Global Regulatory Affairs Consulting Division, specialising in Clinical Trials.  She has more than 16 years regulatory experience and is a member of ICON's CTR Knowledge and Training Team.
 
Jan Ohotski
Jan Ohotski is an Associate Director in Regulatory Submissions at Medpace. He is a subject matter expert on the Clinical Trials Regulation and oversees its implementation within his company.  Jan also specializes in developing advanced therapy medicinal products, an emerging class of medicines offering ground-breaking treatment options. 
 
Hayley Reid
Hayley Reid is a Senior Manager within ICON's Global Regulatory Affairs Consulting Division, specializing in Clinical Trials.  She has more than 13 years regulatory experience and is a member of ICON's CTR Knowledge and Training Team.
  
Katy Thompson
Katy Thompson is a Director within IQVIA Clinical Trial Regulatory Management team.  She has 16 years regulatory experience and oversees IQVIA’s Regulatory Intelligence Database.
 
Book your space today at the Registration page (remember to click “proceed to checkout” after entering details to complete the registration process). Registration for this meeting will close on Sunday 11 March. 
 

Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

 

How to register

Members:

  • Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
  • Once logged in click the 'Register Myself' button that will appear below.

Non-members:

  • If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
  • If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.

Registration is free for TOPRA members and Non-members can register for £45 (which includes two months of TOPRA membership). Student membership of TOPRA is free and is available to full-time undergraduate students. 

 
 
When
13/03/2024 14:00 - 17:00
Where
25 Palmerston Place Edinburgh EH12 5AP UNITED KINGDOM
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