This is a 3-day training programme which spans over three half-days.
Attending the full 3 days is mandatory.

Fee: from € 250.00 per person

11.00 am – 13.30 pm (London, UK)

What you will learn:

• To critically appraise the elements of a Risk Management System and understand the relationships with Pharmacovigilance System processes
• Practical tools for construction of Safety Specification and Risk Management Plans, through critical evaluation of the latest concepts and strategies for risk assessment and prevention
• To critically examine current recommendations and practices of managing risk and analyse the implication for decision making throughout the lifecycle

Day 1 – Tuesday 5th April

11.00am – 11.05am Welcome and introduction to the course   

11.05am – 11.35am Introduction to Therapeutic Risk Management  

• Risk Management Objectives  
• Risk management and Pharmacovigilance 
• Principles and Concepts 
• Introductory Case Studies and Examples 

11.35am – 11.40am Q & A  

11.40am – 12.10pm Global Risk Management Regulations & Guidance 

• Current regulations and guidance relevant to global risk management 
• Risk management guidance 
• Principles of the Core RMP 

12.10pm – 12.15pm Q & A  

12.15pm – 12.25pm Refreshment Break   

12.25pm – 13.10pm The EU RMP – an Overview 

• Introduction to the EU RMP Template 
• Creating an EU RMP  
• RMPs for different product types (new chemical entities; biologics; generics; biosimilars) 
• Introduction to Safety Specification, PV Plan and Risk Minimisation 
• Practicalities and considerations 
• Case Studies and Examples 

13.10pm – 13.30pm Interactive Q & A  

Day 2  – Wednesday 6th April

11.00am – 11.05am Recap of learning so far! 

11.05am – 11.35am In-depth review of Safety Specification, PV Plan and Risk Minimisation 

• Part II: Safety Specification 
• Part III: PV Plan: Routine and Additional Pharmacovigilance  
• Part V: Routine and Additional Risk Minimisation  
• Examples and Case Studies 

11.35am – 11.40am Q & A  

11.40am – 12.10pm Risk Management throughout the Lifecycle 

• Core RMP  
• Development risk management plans 
• Risk Management Plan lifespan and updates 
• Examples and Case Studies 

12.10pm – 12.15pm Q & A  

12.15pm – 12.25pm Refreshment Break   

12.25pm – 12.55pm Practical Considerations from Industry/ Regulatory perspectives 

• Risk Management Interaction between industry and regulators  
• Case Studies and Examples 

12.55pm – 13.00pm Q & A  

13.00pm - 13.25pm Risk Management Processes and Inspection readiness 

• Global to Local & Cross Functional Collaborations 
• Risk Management and Signal detection 
• Risk Management and PSMF 

13.25pm – 13.30pm Interactive Q & A   

Day 3 – Thursday 7th April

11.00am – 11.05am Recap 

11.05am – 11.35am Risk management for special populations and situations 

• Holistic view of therapeutic risk management 
• Risk Management in special populations e.g. paediatrics, elderly  
• Medication Errors 
• Risk Overdose, Abuse, Misuse, Diversion 
• Case Studies & Examples 

11.35am – 11.40am Interactive Q & A  

11.40am – 12.10pm Pharmacovigilance Planning  

• Further Characterisation of Safety Concerns 
• Post Authorisation Safety Studies  
• Case Studies & Examples 

12.10pm – 12.15pm Q & A  

12.15pm – 12.25pm Refreshment Break   

12.25pm – 12.55pm Additional Risk Minimisation & Evaluation of Effectiveness 

• Design & implementation of risk minimisation measures 
• Global to Local adaptations and modifications 
• Challenges & Practicalities  
• Evaluating Risk minimisation measures 
• Case Studies & Examples 

12.55pm – 13.00pm Q & A  

13.00pm - 13.25pm Future Considerations for Risk Management 

• Putting it all together 
• Challenges and Opportunities  
• Review of Key Take Home messages 

13.25pm – 13.30pm Interactive Q & A