Advanced Workshop & Round Table Meeting on Pharmacovigilance Planning and Risk Management
11-12 December 2008
This meeting will be held in the Southampton area
- Understanding of the scientific basis for safety specifications and risk management
- Case studies for risk management for small and large pharmaceutical companies
- Practical workshops with examples on how to write pharmacovigilance safety specifications and risk management plans
Data Safety Monitoring Boards
11-12 February 2009
Meeting to be held in Central London
- Evolution and role of Data Safety Monitoring Boards/Data Safety Monitoring Committees
- Chairmanship, constitution and practical aspects
- Corporate impact of decisions
- Statistical integrity of interim analysis performs
- Regulatory and Clinical Trial Directive requirements
- Worked examples in high mortality conditions
- DAMOCLES Project
Monitoring Safety in Clinical Trials and Drug Development
25-26 February 2009
Meeting will be held in the Southampton area
- Objectives of pharmacovigilance planning and monitoring in drug development programmes
- Pharmacovigilance in clinical trials - a regulatory perspective
- Pre-registration pharmacovigilance planning
- Assessing safety issues in the Common Technical Document
- Planning for pharmacovigilance in the new ICH programme
- Implementation of the Clinical Trials Directive and the detailed guidance
- Eudravigilance and proposed DRA tracking of investigational adverse events under the Clinical Trial Directive
- CIOMS VI issues
- Communication for the protection of the trial population
- Monitoring safety with an investigational agent in co-development
- Development of labelling from Development Core Safety Information through to CCSI and the SPC
- SAEs in high mortality conditions
- Unravelling the unexpected
Compliance in Pharmacovigilance and the role of the EU qualified person
13-14 May 2009
Meeting will be held in central London
- Regulatory requirements in Europe and the USA
- Operational and IT aspects
- How to design compliance friendly systems during clinical development and postmarketing
- Audits
- Planning and coping with inspections