SDP1 Regulatory

SDP1: The regulatory aspect for ATMP

Lead: Västra Götalands läns landsting – Gothia Forum

Involved partners: Astra Zeneca AB, CombiGene AB, CellSeed Sweden AB, GE Healthcare Aktiebolag, Karolinska Universitetssjukhuset, Novartis Sverige Aktiebolag, Region Skåne, Region Örebro län, VeriGraft AB, Karolinska Institutet.

SDP1 aims to provide regulatory guidance around ATMPs. The group has produced a web-based regulatory guide for ATMPs: a generic process guide from the pre-clinical to clinical development phase. The project also arranges educational activities together with Vävnadsrådets VOG cell and formulates templates for IMPD, IB, and study protocol for ATMP together with a checklist “GMP for ATMP”. Templates will be available for partners of CAMP and Swelife ATMP through partner login at this web page.

Examples of tasks and actions:

* Linking together CAMP, Swelife-ATMP and Vävnadsrådets VOG cell in terms of regulatory issues on a national level.

* Web-based regulatory guide for ATMP.

* Check lists and templates for IMPD, IB and study protocol.

* Educational program together with Vävnadsrådets VOG cell.

* Mapping of hospital pharmacy functions for ATMP and other relevant systems/functions.

See the final report of the project here;

SDP1 Slutrapport Swelife-ATMP systemutvecklingsprojekt

Bilaga 1 Regulatory guide for ATMP: a generic process guide from preclinical to clinical development phase for ATMPs

Bilaga 2 Investigational medicinal product dossier (IMPD) for ATMP

Bilaga 3 Investigator´s brochure (IB) for ATMP

Bilaga 4 Clinical study protocol for ATMP

Bilaga 5 GMP checklist for ATMP manufacture

Interview with project leader

Hi Ann Novotny!

What is the need your project addresses?

The need for knowledge and support about the regulatory aspects within ATMP, the need for overview of systems and visible channels in which you can get contact and support.

What is your approach to meet the need?

Listen to researchers, small and big companies and people working in the hospitals. We then try to collect relevant information and know-how on a national level and transfer it into templates, guides and education that is accessible. Everyone have their own list of things they are struggling with; each product or project is unique in some aspect. Our project group hopes to satisfy some of the items and is open for contact and input from anyone!

How will this improve Sweden´s capabilities within ATMPs?

We aim to increase the competence around ATMP development and regulations, creating accessible knowledge and a visible network. A competent network which is easy to contact will improve Sweden´s capability to support developers that want to bring ATMPs to clinic and to market.

For more information please contact Ann Novotny