TOPRA In Sweden - Clinical Trials (FIH Studies)

TOPRA In Sweden - Clinical Trials (FIH Studies)
TOPRA In Sweden present a webinar on Clinical Trials. This evening is an excellent opportunity to discuss early clinical trials of medicinal products, First-in-Human (FIH) studies.

When:  8 December 2020 | 18:30–21:00 CET (GMT+1)
Where:  Online



Agenda

Please note: this webinar will be conducted in Swedish. You can download the agenda in Swedish here (PDF)

Start time is 18:30 pm CET (GMT+1). All times below are CET. If you have any questions on the webinar subject please contact toprainsweden@topra.org 

18:30 – 18:35 Introduction
Speaker: Margareth Jorvid - Methra Uppsala AB, LSM group

18:35 – 19:05 The Medical Products Agency's review of FIH studies
• Regulations and guidance
• Application and review
Speaker: Gunilla Andrew-Nielsen - Medical Products Agency

19:05 – 19:35 FIH studies at CTC
• Planning / preparation
• Implementation
Speakers: Sandra Kuusk, Erik Rein Hedin - CTC, Uppsala

Short break

19:45 – 20:10 Stable Therapeutics - FIH study
• STA363 for chronic degenerative back pain
• Planning / Implementation
• Experiences
Speaker: Andreas Gerward - Stayble Therapeutics, Gothenburg

20:10 – 20:35 Ilya Pharma – FIH study
• ATMP, gene therapy for wound healing
• Planning / Implementation
• Experiences
Speakers: Evelina Vågesjö, Peter Frank, Pia Dahg - Ilya Pharma, Uppsala

20:35 - 21:00 Question & Answer session

Contact us

Contact membership@topra.org or Margareth Jorvid, LSM Group, margareth.jorvid@lsmgroup.se, if you want to become a TOPRA member. 


Fees

  • TOPRA Member or MPA employee – Free.  The discount code for MPA staff: MPA100
  • 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.
When
08/12/2020 17:30 - 20:00
Where
ONLINE
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