The purpose of the webinar was for UKHSA/ CTDA to discuss the lessons learned and observations on the process from their perspective with a view to looking and improvements and determining the next steps.
Dame Sue Hill took part in this and set out the reasons and her thoughts.
The feedback from members was overwhelmingly that of frustration and disappointment at the approach with muted questions and comments and the single-minded view of those involved.
BIVDA has been asking for CTDA to be more transparent and speak directly to members since the inception of this legislation in July last year. This webinar is a huge step forward and for those listening carefully there was a humble acceptance from the CTDA that they could have done it better and a lot of the comments and lessons they presented during their slides took on board the comments that we have fed back through the past months. The communication that we get from the key team at CTDA is much better and they are positively trying to do the best they can for us.
ABHI hosted this webinar, as both BIVDA and ABHI take turns in the administration – BIVDA hosted the last webinar when we went through the technical applications and guidance notes.
The management of this webinar meant that there was very little opportunity to put forward anything critical, as the approach ABHI decided to take was one of facilitation of CTDA.
However, BIVDA was tasked with providing the feedback on “What our members are telling us…”
I only had a minute and talked around 3 keys points.
- Transparency on the application process.
- Individual dialogue on applications.
- Understanding of significant changes.
I pointed out the following, the majority of these were touched upon by Laura Fellowes, so there was no need to dwell on them in detail. We have been consistently feeding back the same for some time.
- Companies were asked to send in data in any format and this was an issue, the changes to the data requirements and guidance in retrospect were unhelpful.
- As the process is not competitive, members would have expected it to be more open and faster.
- Applicants do not know where they are in the process and this has a significant commercial impact.
- The evolving guidance documents mean that previous responses may not be applicable.
- Members have expressed that it is difficult to get responses in good time and calls with CTDA would have been more efficient.
- Transparency and understanding of the process of changes to approved products on the approved and protocol lists need to be determined and informed to membership.
BIVDA have since been in touch with CTDA as members who attended will have realised that CTDA are completely invested in this process and BIVDA are ensuring that they are aware that everything isn’t Rosy whilst being as supportive as we can to ensure continued engagement which is paramount.