avatar for Heike Reinstaedtler

Heike Reinstaedtler

Head, Clinical and Medical Quality
Heike serves as Head of Clinical and Medical Quality at GSK Vaccines, a global team responsible for quality oversight and support enabling proactive, integrated and risk-based quality management throughout the clinical and epidemiology study processes. Her focus is to partner with the business in ensuring the compliance of clinical and epidemiology studies as well as support the development of a strong quality culture and mindset throughout the organization.

In 2015, she transitioned from Novartis, where she led the Global Clinical Quality Assurance team accountable to monitor and verify regulatory compliance in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Vigilance Practice (GVP) regulated areas as well as provide guidance to non-regulated areas in Research. Prior to joining Novartis in 2006, Heike spent 15 years in different companies in the area of Regulatory Affairs and GCP Auditing.

During her career, Heike has managed various HA inspections in the clinical and pharmacovigilance area facing inspectors from different health authorities including EMA, FDA and PMDA.

My Speakers Sessions

Monday, February 24

1:15pm PST

Tuesday, February 25

10:45am PST