When: 11/2/2021 | 18:30 – 21:00 CET
Where: Online
This evening is an excellent opportunity to update you on what applies to Named Patient Permission (NPP/Licenser) and CUP for medicines in Sweden. Patients who have a disease that cannot be treated satisfactorily with an approved drug and who cannot be included in a clinical trial may be offered an individual license or be included in a treatment program for a group of patients called CUP. Open to anyone who works with and is interested in regulatory affairs. The event is in collaboration with the Swedish Medical Products Agency.
Please note, this event will be conducted in Swedish. Download the agenda in Swedish
Agenda
18:30 – 18:40 - Introduction by Margareth Jorvid, TOPRA volunteer
18:40 – 19:10 - How does MPA work with NPPs and CUP
Speakers: Hanna Millbourn and Gunilla Andrew-Nielsen - Medical Products Agency
- Different kinds of NPP / CUP and how is an application assessed
- Other countries Nordic / EU
19:05 – 19:35 - Pharmacy role for Named Patient Permissions
Speaker: Karolina Lindbom - Apoteksgruppen
- Role of the pharmacy in the NPP process
- Practical experience (labelling, cold storage, etc)
19:45 – 20:15 - Experience of Compassionate Use Program (CUP) at Roche AB
Speaker: Lena Knoph - Roche
- Practical experience (application, drug management, follow-up)
- Clinical experience
20:15 – 20:45 - Experience from a SME perspective
Speaker: Margareth Jorvid - Immunicum AB
- Handling of NPPs (Expanded Access)
20:45 - 21:00 - Question and answer session
Fees
- TOPRA member or MPA employee (use code MPA200 at checkout) – Free
- Non-member – £45 (includes two months of 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.