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.

  • 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

  

 

Course time
09:00 - 17:00
Programme highlights

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 

  

 

Learning Objectives
  • 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.