10 OCTOBER 2019: “The production of the drug for experimental use”

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On 5 August 2019
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Regulation: the EudraLex vol. 4 GMP - Annex 13 reference legislation Activities related to the preparation of the IMP, description of the process: The incoming material; Primary packaging: production of capsules, inflation, blistering; Secondary packaging: MLAF and labelling[...]

25 June 2019: BASIC PHARMACOVIGILANCE

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On 23 April 2019
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Basic Pharmacovigilance in Clinical Trials: common evaluation tools, the responsibility of the promoter An interactive seminar during which participants will be able to have a regulatory update on current pharmacovigilance obligations in the field of clinical research and an interaction with specialized professionals in the sector, belonging both to the hospital and to the corporate world, with the aim to verify the common tools available to correctly evaluate the PV activities necessary to conduct a clinical trial[...]

7 June 2018: THE ROLE OF THE CLINICAL PROJECT MANAGER IN THE CRO

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On 7 June 2018
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Speakers: – Gabriella Laurora -Director, Clinical Team Management – Chiara Teruzzi – Associate Director, Clinical Team Management – PRA Health Sciences Target: An interactive workshop during which participants will be able to work on cases and will address the following topics: Definition of Clinical Project Manager Competences of the Clinical Project Manager Operational supervision Competences […]

18 April 2018: THE PRODUCTION OF THE DRUG FOR EXPERIMENTAL USE

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On 13 March 2018
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Speakers: – Marina Farina (Workshop and QP Manager) – Stefano Busti (Manufacturing Manager) – Deborah Mansalvi (QAM) – Lara Felici (QCM) – Andrea Mazzini (Supplier Specialist) Topics: Regulation: the EudraLex vol. 4 GMP – Annex 13 reference legislation Activities related to the preparation of the IMP, description of the process: The incoming material; Primary packaging: […]

7 April 2017: Post Authorisation Safety Studies

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On 22 August 2017
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Speaker: Giovanni Fiori, Scientific Director MediNeos Observational Research The following topics will be covered during the course: Definition of PASS Legal framework Methodological aspects Data collection Data management[...]

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On 21 August 2017
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"European Data Protection Regulation - the impact on the activities of CROs". The purpose of the meeting is to offer participants an update of the legal framework in relation to the European Regulation 2016/679/EU on the protection of personal data.

9 May 2017: INTERNATIONAL PAEDIATRIC CLINICAL TRIAL DAY 2017

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On 20 August 2017
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“Helping children create lives they deserve” This year AICRO organizes a Paediatric Clinical Day together with Ospedale San Raffaele, TEDDY and INCiPiT. TEDDY (the European Network of Excellence for Paediatric Clinical Research) is an independent multidisciplinary and multinational research Network, composed by 48 partners from 19 EU and non-EU countries aimed at facilitating the performance […]

28 September 2017: The flow of the experimental drug

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On 18 August 2017
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“The flow of the experimental drug: What’s going on behind the scenes” Proper management of the experimental drug increasingly contributes to ensuring the quality of data obtained during a clinical trial. In this context, the flow of the drug between doctor and patient is well known and described while the upstream and downstream stages are […]

22 June 2017: The Clinical Project Manager

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On 18 August 2017
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“The role of the Clinical Project Manager in the CRO” An interactive workshop during which participants will be able to work on the cases and will address the following topics: Definition of Clinical Project Manager Competences of the Clinical Project Manager Operational Supervision Financial management Resource management Speakers: – Gabriella Laurora – Director, Clinical Team […]

16 March 2018: INFORMED CONSENT

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On 8 August 2017
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Speakers: Simona Cimbro, Sr Manager Clinical Monitoring Stefano Gregoriani, Sr Director Country Operations – Chiltern International The following topics will be covered during the course: General considerations Ownership Requirements for validity of information and consent Mode of expression (written consent) Consent in vulnerable patients Minors Incapable and psychiatric patients Seniors State of need and […]