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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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September 22, 2010 |
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GlobalCompliancePanel, Online Training Webinar
2010-10-19
Why should you attend:
Large and small pharmaceutical companies face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The regulatory framework in Europe presents complex challenges to meeting international requirements effectively.
Areas Covered in the Session: - International Conference on Harmonization (ICH)
- Regulatory Framework
- European Medicines Evaluation Agency (EMEA)
- Eudravigilance
- Electronic submission of ICSRs
- EVWEB
- EUDRA CT Database
- EU clinical trials directive
- SUSARs
- Periodic reporting
- Clinical trial safety reporting
- UK clinical trial regulations
- Eudralex Volume 10
- Eudralex Volume 9A
- Typical Clinical Safety Process Model
- Best Practice Approach to Clinical Safety
- Achieving Best Practices through the Pharmacovigilance Audit
- Required Company Documentation
- Clinical Safety Case Study
- Pharmacovigilance Risk Profile
- Pharmacovigilance Concepts
- Example of an Effective Supporting Information Architecture
- Example of How Signaling Supports Good Pharmacovigilance Practice
- Signaling Fundamentals
- The Pharmacovigilance Audit
Who Will Benefit: - Clinical Safety/Pharmacovigilance
- Regulatory Affairs
- Quality management
- Clinical research & development
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.
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Deadline for Abstracts:
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2010-10-18
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Registration:
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Live live online training only for one participant Price: $245.00 Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
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E-mail:
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webinars@GlobalCompliancePanel.com
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