TOPRA in Sweden: SPOR Online Platform

TOPRA in Sweden: SPOR Online Platform
This evening is an excellent opportunity to discuss experiences with EMA's online platforms IRIS and PLM portal (Product Lifecycle Management).  Open to anyone working with and interested in regulatory questions for pharmaceuticals and medical devices.

 



Date:  Tuesday 9 May 2023
Time: 17:00-20:00 BST / 18:00 – 21:00 CEST
 
Please note this is a face to face presentation, conducted in Swedish.
    
Venue: Medical Products Agency, Dag Hammarskjölds väg 42, Uppsala

This evening is an excellent opportunity to discuss experiences with EMA's online platforms IRIS and PLM portal (Product Lifecycle Management). IRIS is currently used, for example, for applications for Orphan Drug Designation (ODD) and EMA Scientific Advice, but is planned to be gradually expanded to more regulatory processes. PLM is a portal where you access SPOR data as well as login to electronic application form (eAF) and electronic product information (ePI), two major development initiatives within EMA. We discuss how these platforms are used in practice and how we can influence future developments. We will also discuss Drug Shortages and Good Distribution Practice (GDP) and get an update on news from TOPRA.
  

 Agenda

18.00 – 18.30 The evening begins with light refreshments 

18:30 – 18:35 Introduction
                                Rolf Eriksson, Arex Advisor

18:35 – 19:05 Use of SPOR (substance, product, organization and referential) data and online platforms such as IRIS and PLM - Industry Perspective
                               • EMA Account Management
                               • IRIS portal - product-related scientific and regulatory procedures such as ODD, scientific advice, marketing status, inspections and    Medicines Shortages Single Point of Contact (SPOC)
                               • PLM (Product Lifecycle Management) - electronic Application Form (eAF) for variations (pilot) and electronic Product Information
Helena Ardebrandt, AstraZeneca

19:05 - 19:25 SPOR from an authority perspective
                              • How do we use data from SPOR within the MPA
                              • How does MPA work in IRIS and what do we see coming moving forward
Karin Gröndahl, Medical Products Agency

Short break

19:40 - 20:05 Drug shortage - how to ensure that approved drugs are available?
                               • MAH notification and process
                               • Handling and follow-up from the authority
                               • Experiences
Johan Andersson/Maria Wanrud, Medical Products Agency

20:05 – 20:35 GDP, wholesale trade and the role of expert - What does a RP actually do?
                               • Responsibilities of wholesalers and experts
                               • FMD and serialised products
                                • Complaints and withdrawals
                                Katarina Alheim, Arex Advisor 

20:35 – 20:45 TOPRA news 
Margareth Jorvid, TOPRA volunteer

20:45 - 21:00 Time for questions

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
09/05/2023 17:00 - 20:00
Where
UPPSALA SWEDEN
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