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:

+420 224 910 672

(from 09.00-17.30 CET)

+420 226 251 459

(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:

+420 224 910 672

(09.00-17.30 CET)

+420 226 251 459

(non-stop 24/7)

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

+420 22 491 0000 nebo naše další pobočky.

The EMA: 100 not out

Earlier this month, the EMA management board held its landmark 100th board meeting. The meeting was the last to be held at its current Headquarters in Canary Wharf in London, and brought together the former chairs of the Board as well as Executive Directors.
Usually getting to a centenary in any walk of life is cause for celebration and whilst the overall tone and soundbites from the meeting were bullish, the undertones of uncertainty are still running, mainly around the issue of Brexit. In fact, the EMA has gone so far as to state that many of its existing staff members will not take up the option to relocate to the new offices in Amsterdam and, although it has contingency plans in place, there will invariably be a knock-on effect in terms of productivity and lag in processing submissions. There is also a risk of a significant talent drain from the agency, coupled with the potential loss of expert input from the MHRA, depending on how hard the lines will be drawn post-Brexit.

In general, the meeting did touch upon Brexit, with the EMA confirming that the Dutch government has signed a legal agreement detailing the relationship between itself and the agency and its staff. This goes some way to providing reassurance to those staff members that will be relocating, as it will be under the protection of the Seat Agreement. The agency also provided an update on the redistribution numbers of centrally authorised products, which has now reached 370. This activity will be supported by the generation of a knowledge transfer package for each redistributed product that will include the regulatory and evaluation history of the product. This will go some way to helping agencies forecast and plan resources, especially for more complex products.

The board also highlighted the work of the Pharmacovigilance Risk Assessment Committee (PRAC), and particularly the first public hearing back in September 2017 involving patients, doctors and other stakeholders on the usage and safety of valproate. Further public meetings are being planned in the future and it is clear that this is a developing methodology being employed by the EMA in relation to safety reviews for products.

Finally, the board highlighted the progress of the EU clinical trial portal, which has faced delays due to the complexity of building the database as backend systems. The EMA has confirmed that an auditable release of the portal and database is almost ready, with the release now in an intensive phase of testing. Looking ahead, the EMA said it will begin user acceptance testing of the release in November, after the relocated data center is completed, and is planning to audit the system in early 2019. The EMA also said it is paying close attention to how its relocation may impact the completion of the clinical trial portal, especially in the event that key agency or developer staff do choose not to relocate.