A szolgáltatás eszközei
SFL Regulatory Affairs & Scientific Communication GmbH
GmbH (Ltd liab. Co.)
I - Szakmai tanácsadással foglalkozó irodák/ügyvédi irodák/független tanácsadók
Szakmai tanácsadással foglalkozó irodák
(+41) 61 366 71 61
Square de Meeûs 38/40
(+32) 2 401 61 88
Public Affairs Director
SFL Regulatory Affairs & Scientific Communication Ltd (SFL) is a multi-national team with extensive experience in the pharmaceutical as well as medtech industries.
SFL’s core competencies are:
• Regulatory Affairs
• Public Affairs
• Legal Affairs
• Medical Communication
This enables us to understand and meet clients’ needs through every stage of the product lifecycle. Each team member has a proven track record in specific areas of expertise and an excellent understanding of the interconnectedness of the different stages and functions of the lifecycle of a product.
Public Affairs Services
SFL advises organizations on how to engage in the EU debate to shape healthcare policies and regulatory frameworks. Our team has extensive hands-on experience and proven success in contributing to EU healthcare laws and policies. SFL's public affairs team has worked in functions inside the industry as well as in the public sector. Our public affairs services comprise:
EU political intelligence (monitoring, impact analysis of coming/changing laws and policies, news updates tailored to client needs)
Engagement strategy (stakeholder mapping, strategic partnerships, working with industry associations, step-by-step plans to address policy and regulatory matters, support with drafting communication materials, coordination of workshops and debates)
Capacity building (training on Eu institutions and legislative processes, public affairs methods and tools, lobbying codes, advice on internal organizational matters to help clients formulate aligned positions and speak with one voice to regulators and policy-makers)
SFL supports our clients by offering personalized and comprehensive services which, when combined, provide an integrated solution for products from the bench to the marketplace within one consultancy.
SFL offers expertise in the following product classes - drugs, medical devices, in vitro diagnostics, combination products, and ATMPs - and in a broad range of therapeutic areas.
SFL is an associate member of EuropaBio.
Medical Devices Regulation - 2012/0266/COD
In-vitro Diagnostics Regulation - 2012/0267/COD
Clinical Trials Regulation EU No 536/2014
Data Protection Regulation - 2012/0011/COD
European Medicines Agency policy on publication of
clinical data for medicinal products for human use - EMA/240810/2013
EU pharmacovigilance system including Regulation No 1235/2010 and Directive 2010/84/EU as integrated in Regulation (EC) No 726/2004 and Directive 2001/83/EC
EU personalised medicine activities such as Use of '-omics' technologies in the development of personalised medicine SWD(2013) 436 final
Orphan Drug Regulation EU No 141/2000
SFL supports its clients with analysis and strategic communication advice on the dossiers and activities listed under ‘Main EU initiatives, policies and legislative files monitored by your organisation’.
SFL also supports its clients in the implementation of such advice, e.g. by drafting position papers, articles and educational materials for the purpose of understanding and participating in the debate.
SFL also did various outreach during 2014 to Brussels stakeholders including members of the European Parliament in the preparation of its own inaugural event in Brussels entitled ‘A common policy vision for the pharma and device field?’ which took place on 3 March 2015.
Link to event report
75%: 2 25%: 2
|Nincs akkreditált személy|
SFL is an associate member of EuropaBio
SFL is a member of Medical Cluster
SFL is a member of Biovalley Basel - the Life Sciences Network
SFL is a member of the British-Swiss Chamber of Commerce
01/2014 - 12/2014
>= 100 000 € és < 199 999 €
>= 100 000 € és < 499 999 €
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