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Drug Safety Research Unit

Global Pharmacovigilance Regulatory Requirements: What's New?

Practical Information

Commencing Date:
tba
Language:
English
Location:
London United Kingdom


Teaching Methodology:
Blended Learning


European Fees:
1190 British Pound (GBP)
Scholarship Possibilities:
No

Course Contact

Drug Safety Research Unit

University Accreditation: No

Individual Course

Description

Programme features - Compliance in the US - how to satisfy the FDA and the US 'Tome' - Compliance in the EU - a regulator's perspective - Volume 9A and the new EU Commission Pharmacovigilance package - The QPPV in the EU - Legal aspects - The use of Electronic Data Standards in supporting compliance - Compliance in licensing and due diligence - Preparing for and surviving a compliance inspection This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.

Outcomes

On successful completion of this course delegates should be able to: - Critically review and interpret current rules and guidelines pertinent to ensuring compliance with relevant pharmacovigilance regulations - Plan and prepare for pharmacovigilance regulatory inspections - Optimise company procedures and processes subject to regulatory inspection

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered