TOPRA in Sweden: Regulatory Support Start-Ups & Academia

TOPRA in Sweden: Regulatory Support Start-Ups & Academia
TOPRA in Sweden invites you to a presentation on Regulatory support to Start-ups / Academia and Scientific Advice (MPA, EMA, FDA).



   


Date:  Thursday 16 November 2023
Time: 17:00-20:00 GMT / 18:00 – 21:00 CET  
  
 Please note this is a face to face presentation, conducted in Swedish.
      
 Venue:  Sahlgrenska Science Park, Biotech Huset, Arvid Wallgrens Backe 20, Göteborg  

A dialogue with regulatory authorities is an important part during the development of a new drug. The Swedish Medical Products Agency, the EMA in Europe and the FDA in the USA all offer opportunities for scientific advice and/or meetings. We will hear how the various procedures work, experiences and when it is best to choose which procedure. We will also hear what support the Medical Products Agency can give to academia and start-ups via the Innovation Office, as well as some news about TOPRA. You get the opportunity to meet colleagues in a relaxed and pleasant environment.

The meeting is open to anyone who works with and is interested in regulatory affairs.
 
  

 Agenda

18.00 – 18.30 Light refreshments (sandwiches and drinks)

18:30 – 18:35 Introduction 
                                Helena Ardebrant, TOPRA volunteer

18:35 – 18:40 Welcome to Sahlgrenska Science Park 
                                Monique Lindblom

18:40 – 19:00 The Medical Products Agency 
                               • MPA support to academia and small start-ups
                               • Innovation office
                               • Meet your Regulator
                        Gunilla Andrew-Nielsen. Medical Products Agency, Uppsala

19:10 – 19:25 When to choose what type of advice/meeting
                               • National vs EMA in Europe
                               • FDA
                               • Experiences
                                Johan Holmgren, AstraZeneca

Short break

19:40 – 20:15 Scientific Advice at the Medical Products Agency
                               • Procedure for national advice
                               • Important points to think about
                               • Experiences 
                        Gunilla Andrew-Nielsen, Medical Products Agency

20:15 – 20:40 Experience from a SME company
                               • Preparation 
                               • Experiences
                       Margareth Jorvid, Alzinova

20:40 – 20:50 TOPRA news
                        Margareth Jorvid, TOPRA volunteer

20:50 - 21:00         Time for questions and networking.
 

Pricing

TOPRA Members: Free [MPA employees - Free. Use code MPA200]  
Non-member: £45 (includes 2 months TOPRA membership)

 

Contact us

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

Questions: toprainsweden@topra.org

 

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.

Any questions, contact: toprainsweden@topra.org.

 
When
16/11/2023 17:00 - 20:00
Where
Sahlgrenska Science Park Biotech Huset Arvid Wallgrens Backe 20 GOTHENBURG SWEDEN
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