SFL Services

SFL a Veristat company: Regulatory Affairs, QA/PV, Medical Writing, Public Affairs, Market Access, Compliance & Clinical Operations, Biostatistics, Programming

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The MHRA published an update for the second year of its delivery plan 2021-2023, which includes:

-Revision of the clinical trials and medical devices frameworks

-New regulatory strategy to science

-Consultation on combination products pathway

https://t.co/gmryPQ3iu5

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With only 15.5% of start-ups having female founders/co-founders, the POWHER award aims to encourage more women to become entrepreneurs.
The award, supported by SFL, seeks to increase awareness by celebrating women entrepreneurs. Join us on 18.11 at the GEW Basel Gala!

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Survey data from the European Commission show that the number of MDR & IVDR applications has increased significantly, which has an impact on the time to certification. Our experienced team can assist you with all aspects of EU MDR/IVDR implementation for medical devices and IVDs.

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The European Commission recently adopted proposals to tighten pollution standards and enhance their implementation:

-Addition of 25 additional compounds, incl. pharmaceuticals, to the list of water contaminants

-Polluter payer principle for micropollutants

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The European Commission presented findings from the dialogue on medicines supply:

- Identification of vulnerabilities

- Areas for action including identification of critical medicines & strategic dependencies, investment in production capacities

https://t.co/HZtNWYmZTm

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SFL is a proud sponsor of the first POWHER Award, which acknowledges and honors outstanding women entrepreneurship in the Basel area.

Get your tickets now to be part of the GEW Basel Entrepreneurship Gala on 18 November!
https://t.co/rpPK86ZAbW

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CPHI has started and Delphine Guérin, Director Business Development at SFL, is looking forward to meeting you there.

Do not hesitate to contact us to set up a meeting if you are also in Frankfurt.

#Pharma, #clinicaldevelopment, #medtech. #biotech

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Expected changes of the #UK medicines and medical devices regulatory framework:

Planned measures for end 2022 / beginning 2023 include proposals to revise the medical devices and clinical trials framework & an ILAP extension to medical devices and combination products.

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This week, the MHRA announced:
•Extended transitional arrangements for medical devices & IVDs: manufacturers will be able to place CE-marked medical devices on the GB market till July 2024
•Postponed entry into force of the new medical device framework by one year to July 2024

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Yesterday, the #EU Council adopted remaining proposals to strengthen the EU's health preparedness and response capacities in the framework of the #EuropeanHealthUnion:
-Serious cross-border health threats preparedness
-ECDC extended mandate
-Medical countermeasures framework

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This week, the @EU_Commission presented its 2023 program (https://t.co/OCHch0aUak). Look out for these proposals:
-Compulsory licensing and SEPs (Q2 2023)
-Medicines variation framework (Q4)
-Critical raw materials (Q1)
-Vaccine preventable cancers (Q3)
-REACH revision (Q4)

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Today, Delphine Guerin, Business Development Director @SFLservices, attends the Trinational HealthTech Days in Basel, connecting with startups and healthcare professionals from this very dynamic, innovative, and international ecosystem. #biotech, #medtech, #ehealth

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@SFLservices and @VeristatCRO present their first joint webinar “Orphan Drug Designation – The Considerations, The Rewards, and How They Differ Between The US and Europe” on 26 Oct 2022 from 7 – 8 PM CET. For more information & to register for free, visit https://t.co/dDYUBFJENX

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Delphine Guérin, Director Business Development at SFL, will be attending @CPHI_Events Frankfurt 1 – 2 November and happy to meet clients and partners to discuss future projects and collaborations!

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The EMA updated its guidance on scientific advice & protocol assistance.
For pediatric development, the revision clarifies which questions are out of the procedure scope and within the PDCO remit, incl.
➡️PIP submission preparation
➡️Waivers & deferrals
https://t.co/LuWhKC0Dci

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To unleash the potential of health data, the #EU is creating a #EuropeanHealthDataSpace.
In the European Parliament, ENVI and LIBE are jointly examining the proposal, while the Council preparatory body started to discuss it.
We will continue to monitor and report further.

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Exploratory talks on a new mandate are now underway. The end of the EU-Swiss negotiations on an institutional framework agreement in May last year has impacted the #lifescience sector.

Our experienced Public Affairs team can help you stay on top of developments.

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On 20 October, Shayesteh Fürst-Ladani, Head of the SFL Group, will speak about “How much clinical data from medical device studies is enough to support application for CE Certification?” and exchange with other panelists and attendees at the 9:00 am ICPM roundtable.
#MEDTECH

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The MHRA's decision to extend the European Commission Decision Reliance Procedure until the end of 2023 aims to ensure that UK patients retain timely access to medicines while the MHRA develops a new international reliance framework.

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Legislation underpinning the #EUHealthUnion is nearing completion: The @EUparliament approved the #ECDC strengthening and the proposal on serious-cross border threats to health, enabling strengthened surveillance, coordination & response to health threats.