Veebiseminaril osalemine
Osalema on oodatud akadeemilised sponsorid ja kliiniliste uuringutega seotud spetsialistid, sealhulgas uurijad, uuringukoordinaatorid, uuringuõed, uuringutega seotud farmatseudid ning teised valdkonnast huvitatud osapooled.
Veebiseminar toimub 10. novembril kell 13.00–15.30 Microsoft Teamsis (liitumislink). Eelregistreerimine ei ole vajalik.
Veebiseminari ajakava
Veebiseminar toimub inglise keeles.
12.45 – Joining and Technical Checks
13.00 – Opening Remarks
Welcome and introduction
Ana Zanoletty Perez (EMA)
13.05 – ACT EU Programme
Overview of the ACT EU Programme and its support to non-commercial sponsors
Lene Grejs Petersen (DKMA)
13.15 – Academia’s Overview: Status, Challenges and Needs of Clinical Research
Briefing from academic institution – Estonia (10 min)
Ave Voit (University of Tartu)
Briefing from academic institution – Latvia (10 min)
Dr. Sigita Hasnere (P. Stradins Clinical University Hospital)
Briefing from academic institution – Lithuania (10 min)
Dr. Justas Nugaras (Vilnius University hospital Santoros Klinkos)
13.45 – National Competent Authorities & Ethics Committees Initiatives to Support Non-Commercial Sponsors
Briefing from NCAs & Ethics Committees (30 min)
Speakers: Gerda Siht (Estonian State Agency of Medicines), Jana Migliniece (State Agency of Medicines of Latvia), Arūnas Vaitkevičius / Egle Daniuleviciute (State Medicines Control Agency of Lithuania)
14.15 – Interactive Session
Q&A (15 min)
Moderators: Juta Kraav (Estonian State Agency of Medicines) and Giacomo Capone (EMA)
14.30 – Coffee Break (10 min)
14.40 – Support and Advice on Clinical Trials for Non-Commercial Sponsors
EMA support and advice offerings for non-commercial developers (15 min)
Massimiliano Sarra (EMA) and Liese Barbier (EMA)
14.55 – European Funding Mechanisms for Clinical Research
Briefing (15 min)
Carlos Gomez Munoz (European Commission)
15.10 – CTR/CTIS Regulatory Support Helpdesk
CTR/CTIS functionalities, regulatory helpdesk, training materials and events (15 min)
Ornela Ademi (EMA) and Shane Feeney (EMA)
15.25 – Interactive Session
Q&A (15 min)
Moderators: Inese Birzule (State Agency of Medicines of Latvia) and Giacomo Capone (EMA)
Seminari juhib: Giacomo Capone (EMA).
Seminari teemade kohta saab küsimusi esitada juba enne üritust Slido keskkonnas SIIN. Küsimused palume esitada inglise keeles. Ette saadetud küsimused aitavad meil paremini mõista osalejate huve ja vajadusi ning valmistada ette sisuka arutelu.
Küsimusi saab esitada ka seminari ajal.
Veebiseminari korraldusega seotud küsimuste korral kirjuta aadressil [email protected].
