Moji razgovori s Emom, prvi dio: Clinical trials and approval

Dear Mr Sincic,

It was nice talking to you earlier today.

As promised, I hereby send you a link to the list of members in our 2 main committees, where you will also find the names of the members for Croatia:

The Committee on Human Medicinal Products (CHMP):

https://www.ema.europa.eu/en/committees/chmp/members

https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp

The Pharmacovigilance Risk Assessment Committee (PRAC):

https://www.ema.europa.eu/en/committees/prac/members

https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac

I could also recommend the following EMA publication which explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the safety of medicines:

https://www.ema.europa.eu/en/documents/other/laboratory-patient-journey-centrally-authorised-medicine_en.pdf

You may also find the following 2 public meetings of interest, where EMA explained the process for the development, approval and safety monitoring of COVID-19 vaccines in particular:

https://www.ema.europa.eu/en/events/public-stakeholder-meeting-development-authorisation-safe-effective-covid-19-vaccines-eu

https://www.ema.europa.eu/en/events/public-stakeholder-meeting-approval-roll-out-covid-19-vaccines-eu

If you have any further questions about EMA’s work on COVID-19 medicines or on medicines assessment in general, feel free to contact me or my colleague, Riccardo Mezzasalma.

Best regards,

Hilde

March 18, 2021 8:01 PM