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Events  » April 27, 2017 - New hope, PA, US - organized by TayganPoint & Bluecrux    

Regulatory Innovation Roundtable

Regulatory Innovation Roundtable

Read the summary on this event.

Learn from industry experts and share in our roundtable discussion how to anticipate capacity roadblocks in regulatory submissions using innovative methodologies. The case study discussion will examine a Global Regulatory Affairs implementation of a new innovative approach as part of its “submit-on-time” improvement program.

Additional topics for discussion include:

  • How to automatically convert submission events into a realistic sequence of trackable tasks.
  • How to communicate and manage the interdependencies between regulatory submissions and supply chain, finance, and artwork activities.
  • How to develop reliable work and lead time estimations and utilize a simple approach using Pareto principles and pairwise comparisons that run through an optimization algorithm.
  • How to gain immediate insights into the root causes of your submission issues and evaluate solution scenarios using a RA Balanced Scorecard.
  • How to capture tangible value through process improvement, project and change management for both resourcing and submission planning.


Registration 2:30pm
Introductions 3:00pm
Presentation by Apostolos Mamakis, Head of Regulatory Operations-GSK Vaccines 3:15pm
Roundtable Discussion and Q&A 4:00pm
Networking Session, Appetizers, and Cocktails 5:00pm

Location: Hotel du Village 2535 River Road, New Hope, PA 18938, U.S.A.

Seats are limited and for regulatory professionals only.


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