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European Medicines Agency releases revised guidance on advanced-therapy classification for public consultation

The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products (ATMPs) to reflect the current thinking of the committee on how ATMPs should be classified.
The Agency has released the paper today for public consultation. Comments should be sent to advancedtherapies@ema.europa.eu by 31 October 2014.
Based on examples, the revised paper clarifies the cases in which medicines can be classified as ATMPs and those in which they cannot. It also discusses some borderline cases and areas where scientific knowledge is limited or evolving rapidly.
The paper clarifies in particular:
1-what constitutes a substantial manipulation of cells or tissues;
2- what is considered as a non-homologous use of cells or tissues (or use for a different essential function);
3- when medicines based on recombinant viral vectors are considered as vaccines against infectious disease and not as gene-therapy medicinal products;
4- the criteria for classification as combined ATMPs, i.e. products that incorporate an active substance and one or more medical devices.
ATMPs are medicines that are made from tissues, genes or cells and may offer groundbreaking new treatment opportunities for many diseases and injuries. So far, the CAT has issued over 100 recommendations for the classification of innovative medicines as ATMPs.
ATMP classification, which is non-mandatory and free of charge, gives access to incentives specific for ATMPs, such as fee reduction for scientific advice, and services offered by the Agency, such as the certification of quality and non-clinical data of ATMPs. The classification also helps sponsors to identify the applicable regulatory framework for their medicine and the development path and the scientific or regulatory guidance to be followed.
ATMP classification, along with other pre-authorisation services offered by the Agency such as Innovation Task Force briefing meetings, often constitutes the first contact between the Agency and ATMP developers. It is often used as a first step to initiate a tailored dialogue on product development plan with the Agency.

 

XXIII Porto Cancer Meeting – Stem Cells and Cancer, Porto, May 2015

The XXIII Porto Cancer Meeting will take place at IPATIMUP, Porto, Portugal, from May 7th to May 8th, 2015.
The meeting, entitled “Stem Cells and Cancer”, will be a good opportunity for scientists working in the boundary between cancer and stem cells.
Click in the following link for more details: http://www.ipatimup.pt/Site/Activityview.aspx?ActivityId=2655

 

INTERNATIONAL CONFERENCE in CARDIOVASCULAR DEVELOPMENT, DISEASE AND REPAIR, Porto, November 28-29th, 2014

SPCE-TC, together with the Portuguese Society of Cardiology (SPC) and the Portuguese Society of Developmental Biology (SPBD), will support an international conference on cardiovascular development, disease and repair entitled HEART WITH]OUT[ BORDERS in Porto, during November 28 and 29th. The conference chair and co-chair of the event are Perpétua Pinto-do-Ó (INEB, ICBAS – U. Porto) and Adelino Leite-Moreira (FMUP – CHSJ).
The website of the event is available in the following link: http://heart-without-borders.com/
The event has been conceived to nurture and promote fundamental and translational cardiovascular biology, which is still emerging in the Portuguese scientific community. The two-day event will bring together national and international leading researchers that will discuss fundamental and translational research on cardiovascular development, disease and repair. SPCE-TC invites all members of the Society to participate in the event.

 

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The annual meeting of the Portuguese Society for Stem Cells and Cell Therapies will be held in Oeiras, at the Riviera Hotel, http://www.rivierahotel.pt/,
Portugal, from October 15 to 16, 2015.
Important dates:
On line registration opening: 27 June
Abstract submission deadline: 4 September
Notification of acceptance: 9 September
Early registration deadline: 18 September
Click here for more details

 

 

 

Anexo de e-mail

 

 

Spinal Cord Injury Iberian Symposium – SCiS 2015, Lisbon, Nov 30th- Dec 1st

The 1st edition of this symposium is organized by Santa Casa da Misericórdia de Lisboa (SCML), AssociaçãoSalvador and ICVS/3B’s Associate Laboratory. It will be dedicated to “New Paradigms in Spinal Cord Injury Regenerative Medicine”.

New Abstract Submission deadline: 15th October

Click here for more details