Speakers:

– Marina Farina

– Andrea Mazzini

– Sonia Moiola

– Pierpaolo Cascino/Davide Mastroieni

– Daniele Pintaudi

Program:

9:30 – 10:00 participants registration

10:00 – 11.30

Introduction:

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;

11:30 – 12.00 Coffee Break

12:00 – 13.15

Shipping, pickup and destruction;
The Quality System: Quality Control and Quality Assurance;
The release of QP.

13:15 – 14:15 Lunch break

14:15 – 16.00

Visit of the workshop to small groups with activities of:
label production;
capsules production;
blistering;

Target Audience:

Training and update for professionals working in the field of clinical research, in particular CRA, CQA, Project Managers. In addition to (new) graduates in scientific disciplines who want to pursue a professional career in the field of clinical research.

Location:

STM – PHARMA PRO, Via Abruzzi, Snc – GREZZAGO (MI)

Entry fee:

€ 150,00

Timetable: 9:30 – 16:00

Estimated: light lunch

AICRO Secretariat:

Antonella Minervini Cell. +39 393 3516898

• Agenda
• Registration form