use this route. SANTE added that the use of VHP is not covered in the survey. EFPIA will
reinforce the possibility of using VHP to its membership. CTFG asked for specific
examples where dis-harmonisation has the biggest negative impact.
Actions:
-
EFPIA: provides more data (breaking down data for COVID-19 developers vs. all responders)
most importantly regarding direct to patient drug delivery (issues related to site accessibility and
consequent protocol deviations); use (including best approaches also outside EU/EEA) and
hurdles of rSDV, use of VHP, concrete examples for recurrent issues stemming from dis-
harmonisation. Some additional data will be available next week.
-
EFPIA shares its response to the survey on rSDV
-
EFPIA: feeds-back to its network that VHP is the encouraged route for better harmonisation
(also in the C19 guidance)
-
GCP-IWG agrees on next steps for collecting information on rSDV from DPAs. SANTE supports
GCP-IWG with this task through CTEG.
-
Post-meeting: follow-up discussion with this group can be planned for early 2021
Thank you for the open discussion today. Let me know if you have any comments regarding the
summary and list of actions.
Kind regards,
European Commission
Directorate-General for Health and Food Safety
Unit B4- Medical products: quality, safety, innovation