Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

ELC Group in early-stage development of novel influenza vaccine

1 million Euro project marks regulatory affairs provider’s entry into pharmaceutical development market

Cambridge, UK, 16th June, 2015 – ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it has signed up for the early-stage development of a novel vaccine targeting prevention of influenza. The project signals ELC Group’s entry into the pharmaceutical development market.

The vaccine development will be overseen by a specialist R&D team at ELC Group, including regulatory vaccines experts who have worked on and regulated a number of key worldwide paediatric vaccines. The highly experience team includes a number of current advisers to the World Health Organisation.

ELC Group is working with pre-clinical partners to carry out toxicity and immunogenicity testing, and is harnessing innovative new techniques to create the novel vaccine. ELC Group will also be responsible for setting up the regulatory pathway to ensure a smooth transition to market and approval from international regulators. The market value of the project assigned to ELC Group is an estimated 1 million Euros.

According to World Health Organisation figures (2014), the global incidence rate of influenza is estimated at 5%–10% in adults and 20%–30% in children. Illnesses can result in hospitalisation and death mainly among high-risk groups (the very young, elderly or chronically ill). Worldwide, annual epidemics rates are currently estimated to result in about 3 to 5 million cases of severe illness, and about 250, 000 to 500, 000 deaths globally.

Commenting on the vaccine development, ELC Group CEO Marco Rubinstein said: “We are very excited to be moving into the pharmaceutical development market with this key launch project, targeting an important therapeutic area. With the ability to take this product through our concept to commercialisation model by our unrivalled team of world-class team experts, we are confident of a successful project delivery.”