| Dokumendiregister | Ravimiamet |
| Viit | MSO-13/6129-1 |
| Registreeritud | 24.11.2025 |
| Sünkroonitud | 25.11.2025 |
| Liik | Sissetulev kiri |
| Funktsioon | MSO Meditsiiniseadmed |
| Sari | MSO-13 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | MSO-13/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Malta Medicines Authority |
| Saabumis/saatmisviis | Malta Medicines Authority |
| Vastutaja | Jevgenija Tamm (RA, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Tanti Shirley at Medicines Authority <[email protected]>
Sent: Tue, 18 Nov 2025 15:21:07 +0000
To: "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; Elin Karlberg <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; Karen Stoltenberg-Nordell <[email protected]>; Johansson Sophie <[email protected]>; TKACHENKO Olga <[email protected]>; "[email protected]" <[email protected]>; "[email protected]" <[email protected]>; "Donal O'Connor" <[email protected]>; Gearóid McGauran <[email protected]>; Michele Meagher <[email protected]>; "Ria Mahon" <[email protected]>; Gwennaelle EVEN <[email protected]>; "[email protected]" <[email protected]>; Misticoni Consorti Adele <[email protected]>; Sofia Ratušnaja <[email protected]>; Helene BRUYERE <[email protected]>; Nathalie MARLIAC <[email protected]>; Carole GILLES <[email protected]>; Pascal DI-DONATO <[email protected]>; Amal ESSAOUIBA <[email protected]>; Stephanie VALLET <[email protected]>; Marie LAURAIN <[email protected]>; Kamel SEDKAOUI <[email protected]>; Anne-Laure CAMARA <[email protected]>; Södergren Anna <[email protected]>; Murielle NGOA-ABADA <[email protected]>; Zmuda Violetta <[email protected]>; Dominique ADON <[email protected]>; Zoubida BERKANI <[email protected]>; Norvad Sigmar <[email protected]>; Paschen Meike <[email protected]>; Vasankari Tuija <[email protected]>; Lisa Svartdal Normann <[email protected]>; Kine Susann Dervola <[email protected]>; Amy Conroy <[email protected]>; Philip Kelly <[email protected]>; Lynda ARNAUD-BOISSEL <[email protected]>; Elaine Kilbane <[email protected]>; "[email protected]" <[email protected]>; "Jannie Wiegand Storgaard" <[email protected]>; Thierry THOMAS <[email protected]>; Diego ALMEIDA <[email protected]>; Catalin Vlasceanu <[email protected]>; Rachel Carolan <[email protected]>; Helene MARTIN <[email protected]>; "Sylvie BORIE" <[email protected]>; Anne Baunbæk Pedersen <[email protected]>; Dounia Bouzid <[email protected]>; Špela Zoran <[email protected]>; Zala Černe <[email protected]>; "[email protected]" <[email protected]>; "Anais Fauche (AFMPS - FAGG)" <[email protected]>; "[email protected]" <[email protected]>; KYPRIANOU Mantalena <[email protected]>; Sorrentino Rosario <[email protected]>; Skott Anna <[email protected]>; Aldrimer Mattias <[email protected]>; Youssef Elena <[email protected]>; Grauers Anna <[email protected]>; Valo Hanna <[email protected]>; Jevgenija Tamm <[email protected]>; Ivanovská Dana <[email protected]>; Dudek Anna <[email protected]>; Tina Jereb <[email protected]>; "Qamrul-Ehsan Esrat" <[email protected]>; Björklund Per <[email protected]>; Gearóid O'Connor <[email protected]>
Cc: Serracino Inglott Anthony at Medicines Authority <[email protected]>; Grech Louise 1 at Medicines Authority <[email protected]>; Farrugia Karen at Medicines Authority <[email protected]>; Gatt Baldacchino Elaine at Medicines Authority <[email protected]>
Subject: [SUSPECTED SPAM] Invitation to Participate in Questionnaire on Clinical Investigations or Performance Studies
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear colleagues,
I would like to express my sincere thanks to all of you who took the time to listen to my presentation on my research. As explained during the assessors forum meeting, I am a student at the University of Malta, presently reading for a Doctor of Philosophy at the Faculty of Medicine and Surgery. I am conducting a research study for my dissertation titled Clinical Investigations for Medical Devices in Small Member States; that is being supervised by Professor Anthony Serracino-Inglott and Dr Louise Grech.
As part of the second phase of the research, a validated questionnaire Clinical Investigations & Performance Studies Questionnaire for National Competent Authorities has been developed to explore the practical challenges faced by National Competent Authorities in overseeing clinical investigations and performance studies for medical devices. The questionnaire features a combination of closed and open-ended questions and will be distributed through a Google Form. Participation is entirely voluntary, and all responses will remain anonymous. Each Competent Authority is kindly asked to submit one consolidated response.
Your participation is strongly encouraged, as your insights are essential to building a comprehensive and representative dataset that will support future harmonisation efforts in this field.
You can access the questionnaire here: https://forms.gle/fxS7FhmMRvdtmSP47
Thank you once again for your attention and support.
Best regards,
Shirley Tanti
