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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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February 24, 2020 |
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CfPA- The Center for Professional Advancement, Paris, France
15-16 June, 2020
Who Should Attend?
The course is designed for people who are considering a career opportunity in GLP study direction or those who are already GLP study directors and wish to refresh or perfect their knowledge about running studies in compliance with GLP. The course will benefit the following individuals:
• Existing Study Directors who wish to upgrade their competence in a
multi-site situation
• The newly appointed Study Director
• Study Supervisors who wish to become Study Directors
• Study Monitors
• Principal Investigators in the field of Preclinical Regulatory R&D
• Coordinators of multi-site projects
Maximize Your Learning!
Attend this course and its Companion Courses:
Good Laboratory Practices (GLP)
8-10 June 2020 • Paris • Course ID #545
GLP and Quality Assurance: Developing a GLP Compliant QA Program
11-12 June 2020 • Paris • Course ID #2564 Course Description
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Organized by:
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CfPA- The Center for Professional Advancement |
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Invited Speakers:
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 David Long, Long and Associates International Consulting Ltd. |
David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône-Poulenc he was Senior Director R&D worldwide for Quality and for Process Improvement. Mr. Long has since worked for CHIMEX, a manufacturing subsidiary of the L’Oreal group and now runs his own consultancy company.
David Long has always shown a keen interest in promoting professional QA activities. He was a founding member and President of the French QA Society and a founding member and President of the European QA Federation. He was also the founder and Chief Editor of the Quality Assurance Journal, an international scientific journal specifically addressing subjects of interest to R&D and QA personnel.
He has lectured and trained widely and has been an active participant in developing training in Good Practices and QA, working with a number of international groups including the OECD and the WHO. His latest contribution through the WHO has been in the co-authoring of a set of guidelines for research performed upstream of the regulatory scene, called “Quality Practices in Basic Biomedical Research”.
| Course Director | | | Philip Withers, GLP training and compliance consultant |
Philip Withers was Director of Quality Assurance at MDS Pharma Services in France and has been involved in preclinical QA for over 35 years. For 25 years he worked in non-clinical contract laboratories in England and France where he set up the quality assurance programme worldwide. Mr. Withers was a member of the organising committee of SoFAQ (the French national QA society), past chairman of the multi-site working party and senior editor of the Quality Assurance Journal. He has presented many papers at international QA meetings and has been involved for several years in developing a variety of training programmes nationally and internationally including OECD training workshops.Twenty years ago he created his own GLP training and compliance consultancy. |
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Deadline for Abstracts:
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N/A
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Registration:
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Please click here for registration information.
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E-mail:
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knee@cfpa.com
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WWW: Kai Garlipp,
Frank S.
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7.0 © 1995- HUM-MOLGEN. All rights reserved.
Liability, Copyright and Imprint. |
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“Tell me and I forget, teach me and I may remember, involve me and I learn”
This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem solving and thus learn about how to run regulatory studies that must be performed in compliance with Good Laboratory Practice (GLP) Regulations.
Overall, the main intent is to review the roles and responsibilities of the STUDY DIRECTOR who is in overall control when running GLP studies. The learning initiative is achieved through short lectures, illustrative answers to FAQs and by collective problem solving workshops. The aim is to ensure that each participant is personally faced with real life situations for which a study director has to find GLP compliant solutions.
To understand GLP study direction you must understand how studies are planned, performed and reported. So the course also includes workshops on protocols (study plans), the implementation of procedures and the importance of the study report within the context of the GLP safety studies. The participants will also be challenged with the issues of study integrity and the problems of study reconstruction.
At every research laboratory, GLP study directors inevitably have problems of GLP implementation. The participants will be challenged to give their own reactions to real-life situations and to solve the issues arising in a way compliant with the regulations.
Involving the participants in GLP decision making processes means that they will learn and understand rather than just receiving information as they would from a standard course.
The course will concentrate on existing OECD and FDA Good Laboratory Practices and their application to the workplace including recent developments such as multi-site and short term studies.
Although there will be ample time for participants to ask questions, the course directors will also hold an optional, free, two-hour “GLP Study Director - Clinic” after the end of the course for those who have detailed or specificc problems that they would like to discuss with them, either privately (if your institute considers the issue to be confidential) or openly with all participants if the topic does not require confidential treatment.