PHARMABIOTIC RESEARCH INSTITUTE
Acronym: PRI
General Information
Identification Code: 897994636209-21
Website: [object Object]
Entity Form: ASSOCIATION
Registration Category: Non-governmental organisations, platforms and networks and similar
Registration Date: 10/14/2019
Last Update: 5/9/2024
EP Accredited Number: 0
Mission & Interests
Goals: The PRI is a non for profit organization supporting its academic and industry members in their effort to develop microbiome-based medicinal products.
The PRI is the only European Excelence Center for Microbiome Regulatory Science and supports its members in their interaction with the competent authorities (EMA and national) in order to better understand the expectations of the medicinal products competent authorities in regards to microbiome-based medicinal products in absence of a dedicated European regulatory framework.
The PRI is also the first network for the European microbiome pharmaceutical supply chain, federating fundamental actors such as stakeholders involved in the development, investment, production and commercialization of microbiome-based medicinal products within the EU.
Interests Represented: Promotes their own interests or the collective interests of their members
Interests:
- Public health
- Research and innovation
Levels of Interest:
- european
Activities
Main EU Legislative Proposals: - Contribution to New Eu strategy : Pharmaceuticals – safe and affordable medicines
- Contribution to Roadmap on Revision of Blood, Tissue and Cells Legislation
- Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC: Participation to 2 stakeholders workshop and in the public consultation.
- Revision of the general EU Pharmaceutical Legislation:
Participation in 1 stakeholder workshop and participation in the public consultation on the following proposals
i) Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
ii) Proposal for Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Communication Activities: Information about the release of the proposal and opening of the public consultation on
i) Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Were disseminated to the PRI members and PRI network:
https://www.pharmabiotic.org/european-commission-makes-public-proposed-revision-to-btc-regulation/
https://www.linkedin.com/posts/pharmabiotic-research-institute-pri_the-pri-members-area-is-online-the-activity-7069616765948817408-pWE3?utm_source=share&utm_medium=member_desktop
Inter-institutional or Unofficial Groupings: N/A
Head Office
Address: 1 quai Valliereresidence ile verte, Bat A, Apt 108
Post Code: 11100
City: Narbonne
Country: FRANCE
Phone: [object Object]
EU Office
Address: 1 quai Valliereresidence ile verte, Bat A, Apt 108
Post Code: 11100
City: Narbonne
Country: FRANCE
Phone: [object Object]
Financial Data
New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]
Complementary Information: The European Union Horizon 2020 - grant Agreement 964590 (IHMS-CSA project) is for a three years project which has started on May 1st, 2021 and has granted the PRI 127 000€ for three years.
The PRI has recieved a first payment from the project coordinator (INRAE, France) of 48000 euros in july 2020 (PRI fiscal year 2020-2021) .
Then the PRI has also received another payment of 47868€75 on June 2022 from the project coordinator (INRAE, France) <=> Fiscal year 2021-2022 for the PRI.
The 2022-2023 fiscal year is not closed yet but no payment has been made by the coordinator during the fiscal year.
Membership Information
Members10 Percent: 2
Members25 Percent: 0
Members50 Percent: 0
Members75 Percent: 0
Members: 2
Members F T E: 0.20000000298023224
Info Members: The 2 persons involved are regulatory science experts.
Structure
Structure Type: Structure
Is Member Of: https://www.pharmabiotic.org/our-members/
Organisation Members: No membership in any other organization