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.
|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.
RSVP to firstname.lastname@example.org
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