Portfolio Assessment Completed (required)

We have not assessed the impact of JCA regulations on our portfolio

We have mapped out which assets are within scope of the JCA regulations and when

We have undertaken PICO prediction to assess probable consolidated PICOs

We have planned additional evidence activites to address probable consolidated PICOs

Development Plan Updated (required)

We have not updated the product development plan(s) to incorporate JCA implications

We have started to discuss the implications of JCA for oncology and ATMPs in our portfolio

We have started to discuss the implications for all assets in our portfolio

We have updated our Development Plans to include broad integrated evidence to meet JCA requirements

Roles Clarified including decision rights (required)

We have not assessed roles and responsibilities regarding JCA implementation

We have assigned a JCA implementation lead who will clarify roles and responsiblities

Roles and responsibilities have been agreed within function/region but not rolled out to all

Roles and responsibilities have been fully agreed and rolled out across functions and geographies

Resourcing Planned and Secured (required)

We have not planned any resourcing for JCA implementation

We have assessed the anticipated workload associated with JCA implementation and are building our resource requirements

We have requested the resources required aligned with our budget planning cycle

We have the resources in place to be able to generate additional evidence and to deliver our JCA submission

Cross functional teams aligned (required)

We have not assessed awareness of JCA within our organisation

We have run cross functional JCA awareness sessions within our organisation

Functions are individually plannning for the implementation of JCA

We have cross functional alignment on how JCA will impact current practices and who is responsible for which element

Processes updated and embedded (required)

We have not reviewed our existing SOPs

We have drafted new SOPs to incorporate JCA for relevant assets whilst maintaining existing process for out of scope products

We have approved new SOPs to incorporate JCA for relevant assets whilst maintaining existing process for out of scope products

We have embedded new SOPs to incorporate JCA for relevant assets whilst maintaining existing process for out of scope products

Name (required)

First Name

Last Name