GOOD CLINICAL PRACTICE SEMINAR FOR PHARMACEUTICAL AND REGULATORY AFFAIRS PROFESSIONALS (Spanish version here)
Trainer:
Manuel Jesús Guerrero Roy, Technical Director of PKTJEDA S.T.I., has over 30 years experience in the clinical research industry. He has worked for Instituto ILVEM, Institut de Ciencia y tecnologia (IUCT), Oftaltech, etc. and is an expert in implementation and auditing of quality systems in the pharmaceutical sector. He is also an associate professor, teaching a variety of pharmaceutical courses and master programs in several Spanish universities (such as University of Barcelona, IUCT, University of Vic, etc.). Last but not least, he has extensive expertise in System and Process Validation, Industrial Safety, Quality Assurance, GxP, Health and Pharma Regulations, R&D Project Management, etc. For more detailed information, please see the attached Curriculum Vitae.
Course Objective
The objective of the seminar is to discuss key regulations and their practical application as described in the ICH E6 guideline. Our main goal is to ensure success in regulatory compliance, and give all participants the opportunity to exchange valuable experience amongst each other. They will learn about the ethical issues, requirements for subject safety and the key responsibilities of those involved in clinical investigation.
Auxiliary materials would be provided on the spot and, upon the seminar’s completion, each individual would be awarded a certificate of attendance. Different levels of discounts are available for groups of people, depending on their number.
Who should attend?
- All clinical research personnel responsible for implementation of clinical trials such as investigators, sub-investigators, clinical research coordinators, CRAs, monitors, clinical research nurses, etc.
- Ethics committee members
- post graduate students
- personnel from pharmaceutical companies, CROs, SMOs
- everyone who wants to update his knowledge in ICH-GCP
Course Agenda:
- Principles of GCP: Why, Who and How
- ICH concept
- Historical approach
- Objectives of one Clinical Trial
- Drug development process
- GCP principles
- GCP documents (CT documents, SOP’s…)
- Clinical trial “characters”, functions and responsibilities
- Informed Consent
- Protocol
- CRF
- Workshop
Dates:
3 December 2011 Start: 9.00 – Finish: 17.00
Venue:
Novotel Barcelona City
Avenida Diagonal 201
(Entrada por Ciutat de Granada)
08018 BARCELONA
SPAIN
Fee:
270 EUR (early bird booking, until 30 September 2011)
320 EUR (regular booking, until 31 October 2011)
50 EUR discount if you bring a friend with you
The fee includes course documentation as well as mid-session refreshments and lunch. Invoice and confirmation will be forwarded to you.
Discounted Rates
Available on application for personnel from non-profit organizations, research foundations as well as students from Spanish universities.
Group discount available on request.
Contact:
Victoria Norman
