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Drug Safety Research Unit

Pharmacovigilance in Products Subject to Licensing Agreements

Practical Information

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


Teaching Methodology:
Face-to-Face


European Fees:
1190 GBP
Scholarship Possibilities:
No

Course Contact

Drug Safety Research Unit

University Accreditation: No

Individual Course

Description

At a time when company strategies increasingly look to strengthen their portfolios through in-licensing, co-development, co-marketing or co-promotion opportunities this course aims to help pharmacovigilance professionals understand the impact of such arrangements on pharmacovigilance activities. The course covers the nature and types of relationships where agreements may be required, the approaches required for different types of relationship and what such agreements should contain. The course will be a balanced mix of presentations and workshops facilitated by people with experience in these areas. You will benefit from inter-professional learning with safety, regulatory and legal colleagues, sharing your experiences and comparing your strategies in this challenging area. Outline: - Nature and type of relationships - Due diligence activities - Content of safety agreements - Challenges with International Sales Teams - Perspectives from a small Pharmaceutical Company - Managing relationships - Legal aspects - Compliance and audit - Regulatory expectations – an inspector’s perspective 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

- Describe some types of agreements and relationships and consider the strengths and weaknesses of such approaches in the context of a safety agreements - Demonstrate a critical awareness of modules for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner

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