LOC Specific Storyboards

LOC Specific Storyboards
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  • We would like to add an indication to the program. For the existing indication, we will also need to change the submission date.
  • Changes to Strategy
  • LOC
  • I will need to take this to the GRT. You can come help me explain why it is needed. Then we need to escalate to GPT for endorsement.
  • Regional RL
  • Changes to Strategy
  • RPM
  • We have some items to consider based on the Regulatory Project Plan.
  • Regional RL
  • The purpose for these changes are...
  • LOC needs a new indication and change in submission date.
  • LOC
  • I can look at the impact of changing submission date.
  • GRL
  • We will need to go to the GPT. Let us prepare what we need to present.
  • GSM
  • Changes to Strategy
  • GPL
  • Once we go through everything, the GPT will let you know our decision.
  • GRL
  • We have outlined the strategy and plan.
  • The GRT has a new indication and submission date change for discussion.
  • Regional RL
  • We need to review the Long Range Plan to think through scenarios.
  • Global Marketing
  • Let us discuss how this will affect marketing.
  • GPM
  • When the LOC proposes changes to the strategy and plan for a program, the Regional Lead has to take it to the GRT and GPT. Depending on the changes, the Regional Lead may suggest the LOC join ad hoc to the GRT meeting.
  • Changes to Strategy
  • Today we are discussing a proposal to add a new indication to the program.
  • From commercial, a new indication will have these impacts...
  • We have discussed the considerations for the new indication, plus recognized a need to change the submission date for the existing indication.
  • The Regional Lead, and LOC if they join the meeting, explain to the GRT why the change is required and together they evaluate impacts. A strategy and plan need to be created to present to the GPT for endorsement. 
  • Changes to Strategy
  • The new submission date works with our commercial plans, I agree.
  • Commercial
  • At GPT, the GRL presents the strategy and plan from GRT. They may bring the Regional Lead to help explain and defend the changes. Only after the GPT endorses the changes, can they be incorporated into the program.
  • 
  • Medical Writing
  • QA
  • As the LOC is the most knowledgeable on the patient and market needs, they will recognize when changes need to occur for a program, including adding indications or changing timelines to meet Health Authorities commitments.
  • Market Access
  • It will increase our market and I believe impact to pricing will be...
  • Medical Affairs
  • Once we have reviewed and agreed, I will take to the EMRL. 
  • Commercial
  • LOC
  • Once the LOC Governance has agreement on all considerations on changes needed for an asset, they can be brought to Global via the EMRL.
  • Market Access
  • The new indication will help us reach more patients in need, I am in agreement.
  • Medical Affairs
  • Now that we have all the considerations and are in agreement, I can bring to Global via the EMRL.
  • LOC
  • 
  • GSM
  • LOC Mngmt
  • Publishing
  • LOC
  • Clinical Lead
  • GRL
  • CMC
  • Labeling
  • RPM
  • Regional RL
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