Spring Intro 2023

23/03/2023

• Lack of awareness and understanding of HTA in teams (focussed on regulatory requirements) • Organizational structures (resulting silos) – Regulatory in R&D, Market Access in commercial • Getting the right expertise at the right time – Market Access not always member of the development team. – Resourcing • Global Development • US led development and lack of focus on EU Improving communication and cooperation: the hurdles

The Organisation for Professionals in Regulatory Affairs

33

• Education, training and developing common understanding e.g. TOPRA/NICE meetings and internal awareness • Contribution to initiatives and pilots which aim at a policy and practical level to facilitate convergence • Break down silos ● Market Access colleague networked into development team and/ or Regulatory sub-team ● Integrated Development/Regulatory/Market Access strategy Possible Solutions

The Organisation for Professionals in Regulatory Affairs

34

17