{"id":7249,"date":"2021-05-21T14:49:07","date_gmt":"2021-05-21T12:49:07","guid":{"rendered":"http:\/\/www.aicro.it\/en\/?p=7249"},"modified":"2021-06-10T12:31:37","modified_gmt":"2021-06-10T10:31:37","slug":"21-and-22-october-2021-pharmacovigilance-in-clinical-trials-common-assessment-tools-promoter-responsibility-where-to-optimise-activity","status":"publish","type":"post","link":"https:\/\/aicro.it\/en\/21-and-22-october-2021-pharmacovigilance-in-clinical-trials-common-assessment-tools-promoter-responsibility-where-to-optimise-activity\/","title":{"rendered":"21 AND 22 OCTOBER 2021: PHARMACOVIGILANCE IN CLINICAL TRIALS"},"content":{"rendered":"

21 AND 22 OCTOBER 2021: PHARMACOVIGILANCE IN CLINICAL TRIALS:
\ncommon assessment tools, promoter responsibility, where to optimise activity<\/p>\n

1st Module – 21 October 2021 15:00 – 18:00: Pharmacovigilance in Clinical Trials
\n2nd Module – 22 October 2021 14:00 – 16:30: Focus on surveillance in clinical trials with medical devices<\/p>\n

AICRO organizes a seminar with focus on pharmacovigilance\/surveillance applied to clinical trials and proposed in 2 modules.
\nThe first module related to drug trials, the second module dedicated to clinical trials with medical devices.<\/p>\n

Participants will get a regulatory update on the current obligations in both areas and share practical examples and concerns with expert speakers.<\/p>\n

The proposal is designed for independent promoters and CTCs, who take on a role of responsibility normally delegated to structured departments of pharmaceutical companies, but represents an excellent opportunity for CRAs, CTAs, CTLs and PMs who wish to consolidate their knowledge on the subject through the experience of AICRO speakers.<\/p>\n

TARGET AUDIENCE:<\/p>\n

Training and updating for professionals working in the field of clinical research, in particular independent promoters, CTCs, CRAs, Clinical Team Leaders, Lead CRAs and Clinical Project Managers, researchers in general.<\/p>\n

1ST MODULE – PROGRAMME<\/strong><\/p>\n

21 October 2021 15:00 – 18:00 hours<\/p>\n

15:00 – 15:10: INTRODUCTION TO THE TOPIC AND PRESENTATION OF THE SPEAKER – Elena Ottavianelli<\/p>\n

15:10 – 15:40: Regulatory highlights: focus on promoter liability (Reg 536\/2014, the role of users in Eudravigilance and the delegation process, medical monitoring (when and how to document it) – Mariagrazia Felisi<\/p>\n

15:40 – 16:10: Non-profit studies, the double role of the investigator\/promoter: suggestions on how to set up an effective pharmacovigilance system (optimisation examples) – Elena Carafelli and Melissa Bersanelli (constructive dialogue)<\/p>\n

16:10 – 16:40: Causality and randomness in pharmacovigilance signals: essential evidence for public health decisions
\npublic health decisions<\/p>\n

Daniela Maria Gioia<\/p>\n

16:40 – 17:10: Examples of optimisation: analysis of a budget<\/p>\n

All<\/p>\n

17:10 – 18:00<\/p>\n

Questions and answers<\/p>\n

 <\/p>\n

2ND MODULE – PROGRAMME<\/strong><\/p>\n

22 October 2021 14:00 – 16:30<\/p>\n

14:00 – 14:10 INTRODUCTION TO THE TOPIC AND PRESENTATION OF THE SPEAKER – Elena Ottavianelli<\/p>\n

 <\/p>\n

Pamela Rossi<\/p>\n

14:10 – 14:40 Clinical investigations with medical devices: from mDD\/MEDDEV to the Regulation 2017\/745<\/p>\n

14:40 – 15:00 SAFETY REPORTING PERIOD objectives during the investigation<\/p>\n

15:00 – 15:20 Examples of Reporting of Adverse Event\/Device Deficiency<\/p>\n

15.20 – 15.35 Questions<\/p>\n

15:35 – 16.00 Management of special\/additional situation (concrete examples)<\/p>\n

16.00 – 16.30 Questions and answers<\/p>\n

 <\/p>\n

CHAIRMAN – SPEAKERS<\/strong><\/p>\n

Chairman:<\/p>\n