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Session 6: Am I Compliant Enough?
Session Chair(s)
Angela Van Der Salm, PhD, MSc
Director PV, Managing partner
DADA Consultancy B.V., Netherlands
Elspeth McIntosh, MBA, RN
Director
Castle Pharmacovigilance Ltd, United Kingdom
The actions required to demonstrate compliance may vary depending on company size, products and complexity of processes. This session will look at challenges and potential solutions for small/medium sized companies across a range of activities which affect QPPV oversight.
Speaker(s)
International Infrastructure Challenges (Small vs Large Company)
Peter De Veene, MD
MSD Belgium, Belgium
GQPPV
Small Pharma Challenges and Outsourcing
Angela Van Der Salm, PhD, MSc
DADA Consultancy B.V., Netherlands
Director PV, Managing partner
Challenges in Compliance and Audits
Martijn Van De Leur
Biomapas, Netherlands
COO
Challenges in Computer System Validation
David Stokes
Convalido, United Kingdom
Director and Principal Consultant