Common use of Joint Inspections Clause in Contracts

Joint Inspections. The HTA and HFEA will endeavour to carry out joint inspections of organisations that require a licence from both Regulators, where possible, to reduce regulatory burden. Both organisations will work together to maintain an up to date list of organisations suitable for joint inspections to facilitate the inspection of these establishments where possible. Joint inspections will require the HTA and HFEA to meet prior to and following an inspection, via teleconference or in person, to discuss: - background information about the organisation concerned and its compliance history - information about any regulatory action taken to date and the effect it has had - any areas of concern - the scope of the inspection - which inspectors from the HTA and HFEA will lead on certain areas of the inspection to avoid duplication (e.g. quality management system, consent, etc.) - general observations and any areas of concern - the need to monitor compliance, or follow up areas that require improvement or enforcement actions - where there are areas of co-regulation, which inspection report will note the outcomes of inspection findings (including any non-conformities) - where there are areas of co-regulation, whether the HTA or HFEA will lead on following up the areas that require improvement or enforcement actions (including liaising with the organisation and receiving assurance that actions have been, or are being, taken)

Joint Inspections. The HTA and HFEA will endeavour to carry out joint inspections of organisations that require a licence from both Regulatorsregulators, where possible, to reduce regulatory burden. Both organisations will work together to maintain an up to date list of organisations suitable for joint inspections to facilitate the inspection of these establishments where possible. Joint inspections will require the HTA and HFEA to meet prior to and following an inspection, via teleconference or in person, to discuss: - background information about the organisation concerned and its compliance history - information about any regulatory action taken to date and the effect it has had - any areas of concern - the scope of the inspection - which inspectors from the HTA and HFEA will lead on certain areas of the inspection inspection, to avoid duplication (e.g. quality management system, consent, etc.) - general observations and any areas of concern - the need to monitor compliance, or follow up areas that require improvement or enforcement actions - where there are areas of co-regulation, which inspection report will note the outcomes of inspection findings (including any non-conformities) - where there are areas of co-regulation, whether the HTA or HFEA will lead on following up the areas that require improvement or enforcement actions (including liaising with the organisation and receiving assurance that actions have been, or are being, taken)

Joint Inspections. The HTA and HFEA will endeavour to carry out joint inspections of organisations that require a licence from both Regulators, where possible, to reduce regulatory burden. Both organisations will work together to maintain an up to date list of organisations suitable for joint inspections to facilitate the inspection of these establishments where possible. Joint inspections will require the HTA and HFEA to meet prior to and following an inspection, via teleconference or in person, to discuss: - • background information about the organisation concerned and its compliance history - • information about any regulatory action taken to date and the effect it has had - • any areas of concern - • the scope of the inspection - • which inspectors from the HTA and HFEA will lead on certain areas of the inspection to avoid duplication (e.g. quality management system, consent, etc.) - • general observations and any areas of concern - • the need to monitor compliance, or follow up areas that require improvement or enforcement actions - • where there are areas of co-regulation, which inspection report will note the outcomes of inspection findings (including any non-conformities) - • where there are areas of co-regulation, whether the HTA or HFEA will lead on following up the areas that require improvement or enforcement actions (including liaising with the organisation and receiving assurance that actions have been, or are being, taken)