The first Summit 2019, dedicated to the regulatory impacts and the new European Medical Device Directive, that took place on the 11th of March in São Paulo was a big success! This event organised by ELS Solutions and by Vera Rosas counted with speakers as the CEO of ELS Solutions, Dr Diogo Sousa-Martins, and Dr Mariana Camões, Regulatory and Quality Affairs Specialist also from ELS Solutions.
On the 11th of March, the first big event on Regulatory Affairs in Brasil in 2019 will take place in São Paulo: the 1st Summit 2019, entirely dedicated to the Regulatory Impacts and the new Medical Device Regulation. This event, organised by ELS Solutions and by Vera Rosas will host speakers as the CEO of ELS Solutions, Prof. Diogo Sousa-Martins e a Dr. Mariana Camões, Regulatory and Quality Affairs expert also at ELS Solutions.
Do not miss this current and pertinent event! Knowing in advance the regulatory contingencies in Europe so that you can adapt in time minimising the impact in your organisation. For more information, hit here »
We all know that today technology and medicine go hand in hand, much has been done in this area, nanotechnology is proof of that, especially in cancer treatments. Far are the days of exclusive use of methods from other generations, nanotechnology made an important progress in the fight against this dreaded disease, the one of the most prevalent throughout the world.
The use of this advanced technology in diagnostic procedures, makes us think that the future is now and much more can be done, not only in oncology, but also in other areas of medicine for the good of Humanity and Science.
ELS Solutions monitors and develops several actions in these areas, helping our customers and partners to find innovative solutions.
In europe, from 9th of February on, the presence of a unique identifier (a two-dimensional bar-code) is complimentary in medicinal products for human use, as well as a security system on the outer packaging, which indicates whether the packaging was opened or altered after leaving the manufacturer and guarantees the authenticity of the content. This measure is part of the falsified medicines directive and it will be applied in all member states, except for Greece and Italy, which have until 2025 to update their traceability systems.
At ELS Solutions, we have a rigorous and vigilant regulatory affairs team, watching for changes in legislation, no matter what your market is. We are here to help you comply with legal requisites, make the most of your time and become even more competitive!
On Valentine’s Day, ELS Solutions will tell you how Artificial Intelligence (AI) is about to advance the cardiovascular disease field:
– Identification of novel drugs;
– Determination of who is most likely to benefit from certain interventions, based on genetic information, environment and lifestyle;
– Integration of data from varied sources (wearables, social media, etc) and prediction of disease;
– Remote monitoring of disease using wearables.
For more information, check the American College of Cardiology’s article here »
ELS Solutions partners also with cardiovascular innovators in the field of medical devices and drugs. ELSy® is our patented AI-powered matchmaking pipeline program where you can obtain all innovative pipeline in this field.
Innovation is our passion! Become our partner and innovate with us!
In Portugal, the Portaria n.º 44-A/2019, which refers to the price of preparations and/or substances based on the cannabis plant, was published on the 31st of January. It circunscribes the regulation of the price to a mechanism of communication to the National Authority, INFARMED, I. P.. Its revision is predicted, nonetheless, and it shall evolve to a maximum price mecanism.
The new Portuguese legislation that regulates medicinal cannabis was promulgated on the 1st of February and INFARMED, I. P. created an area dedicated to these products in its website: http://www.infarmed.pt/web/infarmed/canabis-medicinal
ELS Solutions wants to help you develop and introduce your product in the destination market. Come collaborate with us!
As an innovation accelerator, on World Cancer Day, ELS Solutions would like to sum up where we stand on cancer research.
Immunotherapy. A report in 2018 described the clearance all tumors from a woman with metastatic breast cancer using immunotherapy. Currently, there are more than 2500 registered trials using immunotherapy and results will hopefully begin to benefit patients.
Microbiome. One of the hottest science topics at the moment, it is now accepted that bacteria in the gut may influence immune response to cancer and chemotherapy. Modelling the microbiome may therefore contribute to cancer therapy.
Liquid biopsies. The idea behind these is to diagnosis and monitor disease progression using blood tests. Even though these tests’ use is still not recommended for insufficient evidence, efforts are being made in that direction.
Organoids. These are tiny organs grown in the lab derived from patient samples and can be used for testing the susceptibility to several drugs. It is expected that organoids may play a relevant role in cancer treatment in a near future.
For more information, click here »
2018 was a remarkable year in cancer research and, thus, expectations for 2019 are high. We, at ELS Solutions, are exposed to the forefront of pharmaceutical innovation in oncology pipeline and are equipped to undergo the registration and market access of these drugs. Count with us.