EU GVP: SAFETY PROFILE WITHIN A GOOD PHARMACOVIGILANCE SYSTEM
9-10 April, 2019
Riga, Latvia

In 9-10 April, 2019 Riga, Latvia will happen training course “EU GVP: SAFETY PROFILE WITHIN A GOOD PHARMACOVIGILANCE SYSTEM”

Two-day Training Course
Lecturer: Dr. Irene Fermont

LEARNING OBJECTIVES

  • Comply with EU and international regulation
  • Review all processes focused on safety profile
  • Understand the Risk Management
    approach
  • Coordinate and generate PSUR and RMP
  • Standard Operating Procedures (SOPs)
    according to GVPs requirements

Performance & Knowledge Objectives

    • Expand your global safety knowledge
    • Learn to apply the legislation for ensuring compliance
    • Comply with EU and international regulation
    • Understand the Risk Management approach
    • Standard Operating Procedures (SOPs) according to
      GVPs requirements
    • Set up and follow up CAPA – (Corrective Actions,
      Preventive Actions)
    • Use the PV System Master File
    • Review all processes focused on safety profile
FULL INFORMATION
“An amazing experience to participate in training course led by experienced and knowledgeable expert in the field of pharmacovigilance and regulatory affairs, providing so many examples and hints regarding preparation for audit and inspection.”
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CANCELLATIONS: Confirm your cancellations in writing 3 weeks before the date and receive a 50% refund. Should you cancel between this date and 1 week before the date of the course regrettably you will not receive a refund. Customer may reschedule a booking to another date at a 100% rescheduling fee by advising Rephine Balticum of such rescheduling in writing. It may be necessary for reasons beyond the control and the organiser to alter the content and timing of the program or the identity of the trainers. In the unfortunate event that an event is cancelled Rephine Balticum are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to Latvian Law.