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: production of capsules, inflation, blistering;
Secondary packaging: MLAF and labelling
Shipping, pickup and destruction;
The Quality System: Quality Control and Quality Assurance;
The release of QP
Visit of the ECLISSE Workshop in small groups with activities

Audience Target: Training and updating for professionals working in the field of clinical research, in particular CRA, CQA, Project Managers. In addition to (newly)graduated scientists who want to pursue a professional career in the field of clinical research.

Location: Eclisse Euromed Clinical Supply Services srl – Cantù, Via Como 5

Timetable: 9:30-13:15 and 14:15-16:00

The registration fee is per person:

Share equal to € 100,00 + revenue stamp (total € 102,00) is payable by participants belonging to AICRO member companies (without application of VAT);
A fee equal to € 180,00 + VAT (total € 219,60), is payable by participants who are not members of the AICRO.
25% discount on the registration fee from the fourth member and 40% discount on the registration fee from the sixth member.

Registration Form