Clinical Research Related Courses
Part of a STAR Programme

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 one is providing the essential elements in pharmacovigilance, whereas day two consists of practical workshops for the attendees with pharmacovigilance functions. Day one 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
2 day: 09h00 - 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


Programme highlights
  • The mandatory requirements for pharmacovigilance system compliance during medicines products life cycle.
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.
  • Know the elements for pharmacovigilance audits and inspections readiness
  • Understand the principles of signal and Risk management cycles and Risk minimisation strategy
  • Be able to describe the pharmacovigilance quality management – tools for compliance



This course covers competencies that are part of the ECCRT Competency Framework

  • Scientific Concepts & Research Design (1)
  • Ethical & Participants Safety Considerations (0)
  • Investigational Product Development and Regulation (7)
  • Clinical Studies Operations (GCPs or ISO 14155) (7)
  • Study and Site Management (1)
  • Data Management and Informatics (4)
  • Leadership and Professionalism (0)
  • Communication (0)
  • Teamwork (0)
  • Business acumen (0)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Book a course

Date Lang Location
Proceeding your application may take up to 24 working hours. In case of question, contact

Booking is desired 1 week before F2F session in order to allow the participant to go through pre-read materials.
1 500,00 € excl. VAT (if applicable)