Intermediate Level Adverse Event Reporting
Course Objectives
100,000 deaths annually in the US due to ADRs
10% of all inpatients experience a serious ADR
5% of all hospital admissions are due to ADRs
Can you afford to ignore these figures?
The growing awareness of the size and severity of adverse drug reactions, especially with the global use of medicines, has highlighted the need to streamline adverse event reporting and get the right information in the right format as quickly as possible.
This advanced-level course will provide decision-makers with the training and knowledge essential to cope with the demands of pharmacovigilance. Packed full with practical exercises and case studies, there can be no better way to ensure that you and your colleagues act competently and confidently throughout the drug safety process.
What Will You Learn?
- Confidently submit ADR data to global regulators and avoid delays
- Implement FDA/EMEA–compliant eSubmissions of adverse events
- Clarify the effect of the EU Clinical Trials Directive and CIOMS VI on your ADR reporting
- Prepare to meet MedDRA changes and map your databases to MedDRA requirements
- Increase the accuracy of your causality assessments
- Exercise advanced crisis management control
Why should you attend?
Join us to gain essential information and key advice on:
Advanced techniques to enhance your pharmacovigilance preparation and reporting skills
Specific focus on the role of safety monitoring during clinical trials
Clarify the effect of the latest FDA and EMEA guidelines on adverse event reporting
Proactive crisis management skills
Who Should Attend?
Pharmaceutical, Biotechnology and Medical Devices companies, especially within the fields of:
• Regulatory Affairs
• Pharmacovigilance
• Drug Safety
• Product Safety
• Drug Surveillance
• Medical Information
• Post-Marketing Surveillance
• Medical Affairs
• Clinical Safety
• Data Management
Reviews
"Very good course"
"Very good interactive presentation. All interesting aspects were covered"
Related Events
Dates and Venues
15 Apr 2010 - 16 Apr 2010
Regus Trafalgar Square, London, UK
21 Jul 2010 - 22 Jul 2010
Regus Poultry, London, UK
08 Dec 2010 - 09 Dec 2010
Regus Trafalgar Square, London, UK
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
