Module D: On the edge of pre- and post-marketing

Finally, module D discusses trends and topics on the edge of the pre- and post-marketing environments. These include (current) developments in HTA; pricing and reimbursement; and use of medicines (e.g. adherence, off-label use and safety monitoring). These trends and topics include marketing, post-authorization studies and pricing.

Learning objectives

After this module you will be able to:

  • Summarize major trends and developments in the pharmaceutical industry including main challenges, companies’ development strategies and key drivers for developments in the future.
  • Describe and illustrate (give examples) of the implications of utilization patterns after marketing authorization (e.g. adherence, off-label use and channeling, rational use of medicines).
  • Describe the key pharmacovigilance processes (including reporting, good vigilance practice [GVP] and post-authorization requirements) and their rationale, from the perspectives of both the marketing authorization holder and the regulator.
  • Discuss the pros and cons of different measures aimed at informing health care providers on emerging new risks of medicines.
  • Have basic insight into patients’ beliefs about drug treatment (health-beliefs model).
  • Discuss the pathway from market authorization to market access.
  • Describe different EU mechanisms for HTA, pricing and cost-containment (e.g. reference-pricing, price-volume agreements, pay-for-performance).