Description

Clinical Research Related Courses

The course will highlight the mandatory requirements for pharmacovigilance system compliance during medicines products life cycle indicating the main pillars for compliance effectiveness and the relevant key operational processes.

The course is composed of 2 parts*: Day 1 is providing the essential elements in pharmacovigilance, whereas Day 2 consists of practical workshops for the attendees with pharmacovigilance functions.
*Day 1 can be attended as standalone course.

Day 1: Essentials for pharmacovigilance compliance

Morning session: 

  • Pharmacovigilance Systems and sponsors & MAHs responsibilities
  • PV System Quality Management

Afternoon session:

  • Regulatory Intelligence
  • Business Continuity Plan
  • Contractual Agreements 

Day 2: “Advanced course” Pharmacovigilance Business Operations – Key operational Processes

Morning session:

  • Essential / Basic Business Operation processes 
  • PV Tools - EMA go life plan 
  • Medical Monitoring
  • Workshop 

Afternoon session:

  • Signal Management cycle and Risk minimisation strategy 
  • Inspection readiness
  • Workshop 

Q&A - training Closure

Course time
09h00 - 17h0009h00 - 17h00
Who should attend
  • Professionals involved in pharmacovigilance mainly Qualified Persons for Pharmacovigilance (QPPV)
  • Pharmacovigilance Quality Managers
  • PV compliance collaborators 
  • Pharmacovigilance auditors
  • Other stakeholders:
    • CEO, COO of medium to small size companies, as they need to understand the implications and need for compliance in pharmacovigilance
    • Medical Affairs responsible persons
    • Regulatory Intelligence leaders
    • Clinical Operations Staff

 

Programme highlights

The mandatory requirements for pharmacovigilance system compliance during medicines products life cycle

Learning Objectives

Day 1 

  • Understand the essential requirements for PV system compliance
  • Be able to identify the key success factors for Authority Inspections readiness 
  • Be able to self-evaluate PV tasks and management – Risk based approach / gap analysis
  • Become familiar with mandatory pharmacovigilance system compliance including Contractual agreements, expedited and periodic safety reporting in clinical trials and post-marketing  
  • Be familiar with the requirements for Pharmacovigilance system compliance
  • Be acquainted with recent EMA changes that impact Marketing Authorities Holders (MAHs) for 2017 – 2018.

Day 2

  • Know the elements for pharmacovigilance audits and inspections readiness 
  • Understand the principles of signal and Risk management cycles and Risk minimisation strategy
  • Being able to describe the pharmacovigilance quality management – tools for compliance

Book a course

No session currently available.
In case of interest, please contact us.