Paressa Plataki (Obelis)

Health Partnering Day 2015
17 September 2015, Brussels
Personalised medicine
OBELIS S.A.
Fit for Health 2.0 and HEALTH-NCP-NET 2.0 projects are funded by the European Commission
Obelis profile and
expertise
With over 26 years of experience with European Directives &
Regulations, Obelis provides provides CE marking & Regulatory
consultancy services
Obelis covers the NEW Approach European Directives (directives requiring the CE marking and authorized
representative)
–
E.g., medical devices, in-vitro diagnostics, machinery, personal protective equipment, pressure equipment, radio and
telecommunication equipment, electrical equipment, low voltage equipments, construction products, automotive,
cosmetics, toys and consumer goods
Obelis retains a special expertise in Medical Devices, In-Vitro Diagnostics, and Cosmetic Products
Obelis covers EU legislation on Medicines, Biocides, Nanomaterials and Advanced Medicinal Therapeutic
Products (ATMP)
Fit for Health 2.0 and HEALTH-NCP-NET 2.0 projects are funded by the European Commission
One of the founder members of E.A.A.R (European Association of Authorized Representative) & founder of ERPA
(European Cosmetics Responsible Person Association) we participate in different committees at EU Commission
level.
Since 2001, Obelis is a SME, located in Brussels and certified according to ISO 9001:2008 with addition of the ISO
13485:2003 certificate as of April 2012.
Obelis is proud to be the regulatory partner of
-
FP7 NeuroGraft - Development of Functionalised Cell Seeded Bioartificial Organ for Transplantation in Nerve Repair
-
H2020 GLAM - Laser Multiplexed Biosensor
Fit for Health 2.0 and HEALTH-NCP-NET 2.0 projects are funded by the European Commission
H2020 objectives
and mission
Regulation No 1291/2013 on the Framework Programme for Research and Innovation
(2014-2020) :
H2020 directly supports activities covering the entire spectrum from research to market. Bridging actions throughout
Horizon 2020 are explicitly aimed at bringing discovery to market application, leading to exploitation and
commercialization of ideas.
Obelis aims
To
To
To
To
establish regulatory strategies as a mandatory and pivotal requirement for H2020 projects.
elevate the level of proposals presented, towards a patient/product/EU policies oriented mindset.
unfold the fastest and compliant route from innovation to the market.
enhance the European competitiveness by transforming innovative ideas ready to be commercialized.
Fit for Health 2.0 and HEALTH-NCP-NET 2.0 projects are funded by the European Commission
Topic
Proposals review; Indicate the appropriate regulatory road for a successful project
Constant regulatory advise for the quality and regulatory compliance at every stage of development of the project
Compile a compliant technical documentation in order to assure regulatory conformity/approval.
Identify regulatory requirements, standards and specifications
Assist all partners to properly explain, document , justify and validate all analytical tools, experimental steps and
methods used
Contribute to the knowledge of all partners by maintaining an ongoing and close reference to current and future
legislation and regulation
From “Research & Development” to “Product on the market”
Fit for Health 2.0 and HEALTH-NCP-NET 2.0 projects are funded by the European Commission
Contact details
Thank you!
Obelis European Authorized Representative Center
(O.E.A.R.C.)
Registered address:
Bd. Général Wahis 53
1030 Brussels, Belgium
Tel: +32 (0) 2 732 5954
Fax: +32 (0) 2 732 6003
E-mail: [email protected]
Registered office
address:
Av. de Tervueren 34 B 44
1040 Brussels, Belgium
www.obelis.net
Fit for Health 2.0 and HEALTH-NCP-NET 2.0 projects are funded by the European Commission