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Falsified medicines directive

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.

For more information, please check the European Medicines Agency website here, and the INFARMED, I.P.’s communication .

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!

Valentine’s Day

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!

CEO of ELS Solutions, speaks at the 42nd SIMASP

Dr Diogo Sousa-Martins, the CEO of ELS Solutions, will be a speaker of the 42nd SIMASP, one of the most relevant events in Ophthalmology in Brasil, both for physicians and the Pharma Industry. This event is marked by updates on technology innovation and world class trends and offers special courses in the area.

Dr Sousa-Martins’ talk, focused on business in Ophthalmology, will be on the 15th of February at 10.30 am.

For more information on the event, please click here»

Medicinal cannabis legislation update

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!

4th February, World Cancer Day

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.

Innovation in the pharmaceutical industry

2018 was definitely a year of innovation for the Pharma Industry. In the USA, the FDA approved a total of 61 drugs, exceeding its previous record of 50 approvals (in 1996), mostly for rare diseases, infectious diseases and cancer (check Forbes’ link for more information). In Europe, EMA recommended 84 medicines for marketing authorization, targeting mostly cancer, infections and neurologic disorders (access EMA’s report here).

At ELS Solutions, we strongly believe that we can contribute to reduce time to market in helping these products to be commercially available in LATAM and Europe. Using a state-of-the-art methodology for market access, regulatory prosecution and distribution hunting and management, ELS Solutions is equipped to be not only on the forefront of pragmatical innovation but specially to keep the pace of this new drug authorizations’ rhythm.

Medicinal cannabis

Medical marijuana prescription with stethoscope .

On the past 15th of January, the new Portuguese legislation that regulates the use of drugs, preparations and substances based on medicinal cannabis, decreto de lei nº 8/2019, was published (https://dre.pt/home/-/dre/117821810/details/maximized).

ELS Solutions, holder of an innovative methodology for market access, regulatory prosecution and distribution hunting and management, will certainly be the ideal partner to develop your product and launch it in the destination market. We want to help you in this new challenge!

Observatory promotes debate on “Compliance” in Health

Next Thursday, the Portuguese Observatory of Compliance and Regulation will hold a meeting at the Faculty of Pharmacy of the University of Lisbon, which will be attended by the former Minister of Health Maria de Belém Roseira and the former Secretary of State of Health Manuel Delgado.

See the program »

See the full article here »

Health Compliance

Trends and harmonization

Faculty of Pharmacy of the University of Lisbon Auditorium Maria Odette Santos-Ferreira

January, 10
with the presence of Dr. Maria de Belém and Dr. Diogo Sousa-Martins

ELS Solutions at the CPhI Pharma Awards final

ELS Solutions is the 1st Portuguese pharmacist finalist of the world’s largest pharmaceutical industry awards in 2 categories.

ELS Solutions, the only company in the world to provide integrated solutions for pipeline and distribution management, registration and M&A, is CPhI Pharma Awards 2018 (international pharmaceutical industry benchmark awards) finalist in two categories of innovation:

Excellence in Pharma “Contract Services and Outsourcing”, for the innovative ELSy^TM, an advanced CRM application based on artificial intelligence;
Excellence in Pharma “Regulatory Procedures and Compliance”, for the development and implementation of a unique quality and regulatory system based on artificial intelligence – the ELSqr^TM.

“Being globally recognized in the effort to realize our vision and ability to work in innovation, more than an achievement, it is a purpose that will forever position our brand and our employees,” underlines Diogo Sousa-Martins, President and CEO of ELS Solutions.

All competitors to the CPhI Pharma Awards drive for a distinction among hundreds of companies from five continents, evidencing and realizing their innovation capabilities by translating them into original solutions of quality, usability, market opportunity and sustainability.

The winners will be announced on October 9^th, at the CPhI Awards Gala in Madrid, facing more than 500 top executives from the pharmaceutical industry.