General Data Protection Regulation (GDPR)

The new regulation for General Data Protection Regulation (GDPR) is effective as of May 25th, 2018. Any company that does not comply with the new regulation, can face significant fines. This change is one of the most important, if not THE MOST important in the field of privacy regulations in 20 years, and it effects all companies in the entire EU. The territorial scope has been significantly epxanded – also companies outside the EU are impacted, as soon as they do business with partners located in a country within the European community, or collect data from European data subjects.

The new data regulation came into force without a transition period. Every data controller and every data processor need to ensure that they are compliant. HEMEX offers support for companies who would like to get a GDPR compliance check or have specific questions related to the impact on clinical trials, drug development or data collection by medical devices. Contact us today for free advice. Our Data Protection Officer will be happy to discuss your specific situation.

NEW Medical Device Regulations!

New regulations in the Medtech industry (MDR) is calling for swift action to ensure timely implementation and continuous availability of medical devices.

An interesting article on a call for action!

Click HERE for more information.

Do you need support with your existing or new medical devices? Hemex offers support at competitive conditions. Contact us today for free advice.

EU startup fund OPEN!

The lack of private investment for start-ups and small companies in Europe encouraged the EU commission to announce that 410 MIO Euro will be made available to innovative start-ups.

The process to receive those funds shall be simplified. The purpose is to retain companies to migrate to the US. HEMEX is offering partnerships and joint-ventures in order for you to get access to this financial support.

More information about EU funding opportunities here:

EU Funding Opportunities for Startups and SMEs

Contact us today if you need more information related to funding opprtunities.

Information on revision of the Medical Devices Law in Switzerland

After various incidents the control mechanisms for medical devices are being reinforced throughout Europe. Switzerland is also revising its medical devices legislation, closely modelled on the various new EU-requirements, with the aim of improving the safety and quality of medical devices.

Up-to-date information (in English) can be found via THIS LINK.

Let us know if you would like to receive more information how this might impact your products.

EMA’s new Q&A re: orphan medicines

EMA has recently published a question-and-answer document, addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines. Here we have a document that explains key concepts in the regulation of medicines for rare diseases such as orphan designation and significant benefit.

Hemex frequently submits ODD applications for Sponsors of drugs targeting rare diseases. Contact us today for free, confidential advice supporting your plans and projects.

EMA publishes a question-and-answer document on orphan medicines

InnoSuisse Roadshow

Switzerland is the leading nation for innovation for several years in a row, according to the Geneva-based World Intellectual Property Organization (WIPO).

The other countries in the top five for 2017 were Sweden, the Netherlands, the United States and Britain. (WIPO global innovation index). Switzerland has held the top spot since 2011.

Events like the Innosuisse Roadshow held at the Pharmacenter of the University of Basel; organized by Innosuisse in collaboration with BaselArea & the University of Basel are key to maintain that position.

https://www.innosuisse.ch/inno/en/home.html

On their roadshow Innosuisse (former KTI) explains the most important changes and encourages companies to apply for funding’s of their innovation projects and to find suitable project partners.

BaselArea is a significant local partner of the regional Innovation systems and partner of Innosuisse. BaselArea is a joint initiative for innovation and economic promotion by canton Basel-Stadt; Baselland and Jura (NWS).

https://www.baselarea.swiss/baselarea-swiss.html

HEMEX is offering partnerships as SME to university spin-offs or other start-ups in the Life Science sector. Do you have a promising project and you are looking for an SME partner? Let’s talk! Get in touch with us info@hemex.ch

Non-Dilutive Research Funding available!

Non-Dilutive Research Funding for Swiss Biotech companies

The Swiss Biotech Association invited HEMEX to an information event on 12 March 2018 in Bern (Switzerland), regarding the possibilities Swiss biotech companies have for accessing different national and international non-dilutive funding instruments. Our customer solutions team attended the presentations and would be happy to show you the different possibilities. If needed, HEMEX is offering partnerships and joint-ventures in order for you to get access to this financial support.

Contact us today to learn more!

 

LINKS:

https://www.eurostars-eureka.eu/

https://ec.europa.eu/programmes/horizon2020/en/how-get-funding

https://www.cobiotech.eu/

https://www.innosuisse.ch/inno/en/home/go-global/internationale-forschungsnetzwerke.html