21 AND 22 OCTOBER 2021: PHARMACOVIGILANCE IN CLINICAL TRIALS:
common assessment tools, promoter responsibility, where to optimise activity
1st Module – 21 October 2021 15:00 – 18:00: Pharmacovigilance in Clinical Trials
2nd Module – 22 October 2021 14:00 – 16:30: Focus on surveillance in clinical trials with medical devices
AICRO organizes a seminar with focus on pharmacovigilance/surveillance applied to clinical trials and proposed in 2 modules.
The first module related to drug trials, the second module dedicated to clinical trials with medical devices.
Participants will get a regulatory update on the current obligations in both areas and share practical examples and concerns with expert speakers.
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.
TARGET AUDIENCE:
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.
1ST MODULE – PROGRAMME
21 October 2021 15:00 – 18:00 hours
15:00 – 15:10: INTRODUCTION TO THE TOPIC AND PRESENTATION OF THE SPEAKER – Elena Ottavianelli
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
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)
16:10 – 16:40: Causality and randomness in pharmacovigilance signals: essential evidence for public health decisions
public health decisions
Daniela Maria Gioia
16:40 – 17:10: Examples of optimisation: analysis of a budget
All
17:10 – 18:00
Questions and answers
2ND MODULE – PROGRAMME
22 October 2021 14:00 – 16:30
14:00 – 14:10 INTRODUCTION TO THE TOPIC AND PRESENTATION OF THE SPEAKER – Elena Ottavianelli
Pamela Rossi
14:10 – 14:40 Clinical investigations with medical devices: from mDD/MEDDEV to the Regulation 2017/745
14:40 – 15:00 SAFETY REPORTING PERIOD objectives during the investigation
15:00 – 15:20 Examples of Reporting of Adverse Event/Device Deficiency
15.20 – 15.35 Questions
15:35 – 16.00 Management of special/additional situation (concrete examples)
16.00 – 16.30 Questions and answers
CHAIRMAN – SPEAKERS
Chairman:
- Elena Ottavianelli – AICRO Scientific Director, Business Development Manager Fullcro S.r.l.
Speakers:
- Melissa Bersanelli – Medical Director Specialist in Medical Oncology O.U. Medical Oncology A. O.U. of Parma – Contract Professor School of Specialisation in Oncology Dept. of Medicine and Surgery University of Parma
- Elena Carafelli – CRO Unit FV Responsible CTC Fond. Policlinico Universitario A. Gemelli
- Daniela Maria Gioia – PhD, FVG Responsible at Fondazione Italiana Linfomi (FIL)
- Mariagrazia Felisi – Clinical Research Director CVBF
- Pamela Rossi – Pharmacovigilance safety unit Manager, Angelini
PARTICIPATION FEE
For participants belonging to AICRO, AFI, ASSOMONITOR, EUCROF, FADOI, FICOG, SIMEF members, to employees of public structures and no-profit:
– euro 30.00 for a single module
– euro 50.00 for both modules
The receipt, without application of stamp duty and VAT, will be issued by AICRO, Piazza Meda 3 – 20121 Milan
For external participants
– euro 60,00 + 22% VAT for each module
-euro 100,00 + 22% VAT for both modules.
The invoice will be issued by AICRO, Piazza Meda 3 – 20121 Milano – VAT NO. 05913730965
For all:
Nr. 1 free of charge every 2 (two) paying participants
The fee includes: teaching, use of the platform, teaching documentation and the issue of a certificate of participation at the end of the seminar.
