When: Available on demand. (Originally presented in March 2016.)

Benefits

After attending this webinar, participants should be able to

• Understand the concepts and processes of Health Technology Assessment, as used to inform the appraisal of new medicines 
• Understand where Regulatory Affairs professionals may become involved in developing evidence for use in HTA submissions

Outline of content

• Rationale for and development of HTA
• Concepts used in HTA
• Process of HTA, including Scientific Advice
• Points of collaboration between HTA and Regulatory Affairs

Target audience

Regulatory Affairs professionals and colleagues working in R&D in Pharma and other Life Science companies who collaborate with specialists (health outcomes, market access) to develop evidence used by reimbursement agencies, including planning evidence generation programmes. This includes the design of clinical trials to meet different stakeholder needs

The primary audience is those working in (global or regional) medicine development teams focusing on health care systems that use HTA. Those working in specific countries and non-regulatory professionals (clinical, medical, strategic marketing) may find it useful, however the session is introductory and not focused on individual country requirements, nor is it targeted at specialists in evidence generation for or communication to payers.

Why should you attend?

The clinical development programme in Pharma R&D is focused on achieving marketing authorisation with regulatory agencies. However access to and uptake of new medicines is driven by reimbursement agencies and health care payers, with their own evidence needs. Most reimbursement organisations have now implemented some form of Health Technology Assessment process to assess the evidence submitted by manufacturers. Regulatory affairs and related professionals need to understand why, how and when to engage with specialists in this area to support the ultimate goal of enabling patients to access medicines of value to them.

CPD

This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Speaker

• Mike Chambers, MC Healthcare Evaluation (formerly GlaxoSmithKline)
  
  

How do I register?

Prices

Discounted Places

A limited number of discounted places are available at the rates below for those:

• in low income countries as defined by the World Bank
• working for agencies, charities or NGOs. 

Please email meetings@topra.org for a discount code before making your booking.

* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.