Queries and Responses; Execution of Strategy

Queries and Responses; Execution of Strategy
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  • Queries and Responses
  • Regional RL
  • We just received a query. I selected the response team, however, I will send email to entire GRT in case they want to provide additional input.
  • GRL
  • Queries and Responses
  • We need to get the response out for this query quickly, let's start breaking it down and plan how we are going to respond.
  • Labeling
  • CMC
  • Regional RL
  • Clinical Lead
  • QA
  • Queries and Responses
  • Is the response finalized? Is there anything that will affect the strategy?
  • RPM
  • We can put it on the agenda. Any risks and mitigations should be incorporated into the RPP.
  • GRL
  • There are risks that might impact, it would be good to discuss in the GRT.
  • Regional RL
  • When a query is received, the Regulatory Lead reviews the query, informs those that need to be on the response team, and informs the GRL and GRT.  The GRT members can request to be part of the response team but they must be speedy, proactive, and value added.
  • Execution of Strategy - RPM
  • What is the Plan for China?
  • 
  • Great, I will remind the GRT to get back to you asap if they want to be involved since the response cannot be delayed. I look forward to hearing more about it when the response is submitted.
  • We just received regulatory feedback and are putting together our plans.
  • Regional RL
  • The Response team meets to discuss the query, create action plans, develop the responses, and conduct reviews. Some queries have very short turnaround times and the response team and activities need to be tailored to account for this. 
  • Execution of Strategy - GRL & GSM
  • How was the meeting with EMA? Did we get feedback?
  • CMC
  • 
  • The meeting was great. We received feedback that we need to compare to plans to see the impact.
  • Once a response has been submitted, the Regulatory team makes sure everyone is informed. They will coordinate with the GRL and GRT to review if there is an affect on the strategy, plans, execution promoting risks, GRSP, RPP, etc.
  • Execution of Strategy - GRL
  • How are the upcoming submissions? Are there any variations we need to know about?
  • 
  • The submissions are on track. We are expecting some queries based on previous submissions.
  • The RPM actively manages the RPP, updating per any changes in strategy and providing alerts as needed to the team to remain on track in achieving the goals and the strategy.
  • GSM
  • CMC
  • We are working on creating scenarios for submissions and we may need more resources to be brought to GPT.
  • GRL
  • RPM
  • When there is no RPM assigned, the GRL and GSM work together to manage the GRT Forecast, updating per any changes in strategy and providing alerts as needed to the team to remain on track in achieving the goals and the strategy. 
  • GSM
  • I can update the GRT Forecast to see the impacts to the plan.
  • GRL
  • Regional RL
  • When there is no RPM or GSM assigned, the GRL is responsible to manage the GRT Forecast, updating per any changes in strategy and providing alerts as needed to the team to remain on track in achieving the goals and the strategy. 
  • CMC
  • QA has informed us on a new variation. I will provide details to the team.
  • GRL
  • Regional RL
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