Speaker Details
PCMG is delighted to welcome a diverse range of speakers from across the global clinical development outsourcing landscape to join us in Berlin for PCMG26.
Gabriele Schwarz
GCP Strategy Expert, German Federal Institute for Drugs and Medical Devices
Gabriele is a graduate pharmacist who joined Germany’s Federal Institute for Drugs and Medical Devices (BfArM) in 2001.
She currently serves as BfArM’s GCP Strategy Expert, represents the EU in the ICH E6(R3) Expert Working Group, and contributes to ACT EU priority actions aimed at modernising the European clinical research landscape.
Until end-2022, she headed BfArM’s GCP Inspection Unit for over 15 years, having established it from inception, overseeing international pre-approval GCP inspections supporting EMA-coordinated and national marketing authorisation procedures across diverse therapeutic areas worldwide.
She has shaped key European and international regulatory guidance, including
ICH E6(R2), ICH E19, EMA Reflection Paper on Risk-Based Quality Management, EMA Guideline on Clinical Trial Master Files, EU Recommendations on Decentralised Elements in Clinical Trials, and the OECD Recommendation on Clinical Trial Governance.
Register now for PCMG26
As the leading event for professionals in Clinical Development and Clinical Research Outsourcing, PCMG26 brings together sponsors, service providers, and industry experts to exchange insights, explore practical solutions, and strengthen partnerships shaping the future of outsourcing.