Unfortunately, given current circumstances, we have had to postpone our June workshop. Please see below for our revised list of workshops.

 

15-16 September, Bogota, Columbia

Effectiveness of the regulatory approval process – moving from performance excellence to operational excellence

Objectives:

    • Discuss what is required beyond measuring just time to
      understand a regulatory authority’s performance and how this can be utilised by agencies to improve their effectiveness
    • Identify comparative measures of effectiveness that could allow for cross agency learning
    • Make recommendations on a common set of key indicators across authorities that could be used as a measure of effectiveness

 

11-12 June, Tyson’s Corner, USA

Digital Technologies: enabling evidence generation in clinical development for regulatory and reimbursement decisions – how are the regulatory and HTA landscapes adapting?

Objectives:

  • Discuss how agencies and companies are currently developing the role of digital technology for evidence generation in clinical development for regulatory and HTA decision making
  • Identify the opportunities and how to reduce potential barriers going forward for evidence generated, by digital technologies for use in the review and reimbursement of medicines
  • Recommend areas of work/research which could enable ways that will allow alignment across jurisdictions to ensure digital technologies maximise their potential within a fit for purpose regulatory and HTA environment

 

Early March 2021, Surrey, UK

Regulatory and HTA interactions in the development space – is this enabling better evidence generation, improved probability of success and patient access?

Objectives:

  • Discuss the current and future of role regulatory/HTA and HTA/HTA initiatives for interactions within and across jurisdictions
  • Identify through case studies the key areas and types of interactions between stakeholders which are seen as effective models
  • Understand the value they bring to enabling improved decision making by stakeholders and what can be learnt across jurisdictions