Theoretical course for the acquisition of ICH-GCP_rev2 certification

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What is it?

ICH-GCP_rev2 Course in divided in two days, the first day is devoted to the theoretical part and the second one to the final examination. Once the course is passed, the ICH-GCP_rev2 certificate will be issued.

To whom the course is addressed?

The ICH-GCP_rev2 course is addressed to all staff working in clinical research and needing to document the GCP training (it is advised to renew it at least every two years), as required by Italian MD 15/11/2011 and by the GCP itself.It is also recommended in order to improve your CV with documented GCP knowledge.

Program

The course in cludes the GCP history presentation focusing on the reason of creation and steps of evolution. Further more, detailed presentation of eight chapters constituting GCP guideline, will be introduced:

1. Glossary: definition of all terms related to clinical research.

2. The ICH-GCP_rev2 Principles: general principles that underpin the Good Clinical Practice.

3. Institutional Review Board / Independent Ethics Committee (IRB / IEC): procedures and responsibilities of Ethics Committees.

4. Investigator: qualifications, responsibilities and requirements of the experimental centers components.

5. Sponsor: qualifications, responsibilities and requirements of the Sponsor components.

6. Clinical Trial Protocol and Protocol Amendment(s): requirements for the drafting of an experimental protocol.

7. Investigator's Brochure: requirements for the drafting of all collected information regarding the investigational product.

8. Essential Documents for the conduct of aclinical trial: collection and management of the minimum records to be produced before, during and after the clinical trial conduct.

NOTE: Once all lessons have been studied, the test must be performed to obtain the certificate of competence. It becomes available within 1-2 working days after the test completion.

Why should I register for the course?

The GCP certificate is required for all professionals working in clinical research. For those who would like to enter into the world of clinical research, the GCP skills enrich the CV in case of applying for a job at CROs and pharmaceutical companies.

How the courseis performed?

The course will be available on the next day after your registration. Final test to certify the acquired skills will be available 24 hours after admission to the course. Maximum time for obtaining the GCP certificate is three months, after that you will have to proceed with a new registration.