Pharmacovigilance Planning and Risk Management (Hybrid Event)

Course Overview

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, the course dates and programme may be subject to change.
The in-person session of this course will only proceed when a minimum number of participants is met. Should this number not be reached, the registered participants will be notified at least three weeks prior to the course.

Our courses are recognised by PharmaTrain.

Who should attend

This course is aimed at:

• Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
• Staff from regulatory authorities

How our courses work

• Taught over two days
• A combination of lectures and interactive workshops
• Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)
• Full access to PDFs of the presentations afterwards
• Use this course as part of your Continuing Professional Development (CPD)
• Refreshments and lunch provided (in-person delegates)
• Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time

Aims of the 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

Learning outcomes

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

Key topics

Programmed features:

• 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

Our fees

Please note, VAT is only applicable for delegates based in the UK.

Cost Per Delegate:

• Academic

  £620 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - Virtual

• Academic

  £775 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - In-Person

• Standard

  £952 + VAT

  Virtual

• Standard

  £1190 + VAT

  In-Person

Registration fees include electronic access to all course materials. Lunch and refreshments are provided for those attending in-person.

Book now

• 20 September 2023 - 21 September 2023

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  UK Based International

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