Pharmacovigilance Planning and Risk Management
Venue: Solent Hotel, Whiteley, Fareham
Date: 25 Sep – 26 Sep 2019
Risk management is a systematic approach to identifying, assessing, understanding, acting on, and communicating risk issues. All drugs have risks associated with their use, including adverse reactions, interactions between drugs, and the risk that the product may not work as effectively as expected. Manufacturers, regulators, health professionals, and patients all perform risk management activities.
A proactive approach to risk management of drug safety is vital throughout the whole life-cycle of a medicinal product. Our Pharmacovigilance Planning and Risk Management course will critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product.
Understanding the drivers and relationships between safety specification, pharmacovigilance plans, risk minimisation programmes and pharmacoepidemiology will be a central theme. A panel of industry experts will share their personal experiences in managing the risk of bringing new medicines to market. They will outline new approaches to mitigating risk and improving decision making.
Group interactive sessions will analyse ‘real-world’ challenges faced by marketing authorisation holders and regulators.
Our interactive Pharmacovigilance Planning and Risk Management is designed for experienced staff, working in the pharmaceutical industry (for regulatory authorities or research organisations), to critically explore existing and developing strategies to optimise risk management activities for known and potential risks of a product in its developmental stages, pre-authorisation, and for extending safety knowledge post-authorisation.
*Please note that the course dates and programme may be subject to change.
|Our courses are recognised by PharmaTrain.|
Who should attend?
This course is aimed at:
- Experienced colleagues working in the pharmaceutical industry, for regulatory authorities or research organisations
Aims of course
- To critically appraise the elements of a Risk Management System through evaluation of the relationships between pharmacovigilance and risk management plans
- To prepare for construction of Safety Specification and Risk Management Plans through critical evaluation of the latest concepts in tools and strategies for risk assessment and prevention
- To critically examine current recommendations and practices of managing risk and analyse the implication for decision making
On successful completion of this course delegates should be able to:
- Critically interpret the purposes of Risk Management Systems in drug safety and the challenges that Risk Management represents
- Plan, prepare and justify Safety Specification and Risk Management Plans
- Demonstrate a critical awareness of models for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner
- Current regulation and guidance relevant to global risk management
- Safety specification and pharmacovigilance planning
- Risk management activities and the drug development programme
- Stakeholder perspectives on construction and execution of Risk Management Plans
- Development of best practice techniques
- Management of drug safety after reclassification
Cost Per Delegate:
£775 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£1190 + VAT Standard
Download Course Programme
Click here to download the programme
“Really interesting and experienced speakers. All questions very well answered.”
“Very informative and comprehensive course with good interactive sessions. Good, qualified speakers covered relevant topics in detailed manner.”
“A great course. Would definitely recommend.”
“Experienced speakers with good balance of perspectives. Excellent setting with helpful and friendly organisers.”
“Excellent course. Good mix of industry and pharma speakers. The speakers provided examples/real life examples which were really useful.”