Shruthi Vidyasagar, GlaxoSmithKline - Qepler Summits And Conferences

Shruthi Vidyasagar

Device Development Technologist, R&D Platform Technology & Science
GlaxoSmithKline
London, United Kingdom
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Shruthi is a Device Lead at GSK (Ware, UK) managing late stage parenteral projects.

Prior to GSK, she worked at Pfizer in North Chicago on differentiated drug delivery systems. She has device development and regulatory experience across multiple platforms - combination products, electromechanical devices and consumable products.

Her recent focus has been on parenteral combination products- syringes, injectors, closed transfer devices, etc supporting all activities from development to launch.

Shruthi holds a BE in Electrical Engineering (VTU, India) and an MS in Biomedical Engineering (University of Michigan, Ann Arbor).

Related Sessions:

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
BLOCK: SIMPLIFYING PROCESS WITHOUT COMPROMISING ON QUALITY.
CASE STUDY: Combination product control strategy.
  • QbD Approach to Control Strategy- Drug Product vs Device
  • Design Space Exploration through Modelling and Mechanistic Understanding
  • Regulatory expectations and industry trends
  • Opportunities and Challenges
  • Case Study - Final Product Release Tests
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