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Tapes Library
Adverse Event Reporting: What’s new in European Clinical Safety Surveillance / Pharmacovigilance
Speaker:
 Dr. Elliot Brown, Managing Director, EB Consulting
Date of Briefing:
 February 15, 2005
Approximate length:
 One hour
Description:

This briefing will review key aspects of EU Pharmacovigilance such as: newly expanded EU with new regulations affecting pharmacovigilance; new guidelines on clinical trials and requirements for electronic reporting of individual case safety reports; and FDA and EU regulators and formal agreements for exchange of information on safety, including inspection findings.
Price:
 $225 Tape
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Tapes Library
Adverse Event Reporting: Comparability Protocols
Speaker:
 Elizabeth Leininger, Ph.D., Biologics Consulting Group
Date of Briefing:
 January 13, 2004
Approximate length:
 One hour
Description:
 This is the assessment of Elizabeth Leininger, Ph.D., Senior Consultant, Biologics Consulting Group. Dr. Leininger says the bottom line is to “demonstrate the lack of adverse effect on safety and efficacy…Early on manufacturers need to define process and product, scale- up and process optimization. If there are changes, it’s critical to show the products are comparable.” If you or your clients are responsible for comparability protocols or similar activities, buy this CD now for this information-packed and most timely audio advisory by Dr. Leininger.
Price:
 $195 Tape
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Tapes Library
Adverse Event Reporting: Safety Reports on Human Drugs and Biologics
Speaker:
 Stuart Kim, Regulatory Counsel, Abbott Laboratories
Date of Briefing:
 July 31, 2003
Approximate length:
 One hour
Description:
 The Food and Drug Administration (FDA) recently published an extensive rule intended to improve the monitoring and safe use of human drug products, both during clinical trials and once they are on the market. The proposed rule would implement certain international standards for safety reporting, including terminology, format, and timing. These standards were developed by the International Conference on Harmonization (ICH) to improve the quality, consistency, and usefulness. The proposed rule also would require a company to submit to the FDA -- within 15 calendar days -- all reports it receives of actual and potential medication errors. Industry representatives have indicated the proposed rule goes well beyond international standards.
Price:
 $195 Tape
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Go to the Order Form

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