Vicky Valla

Regulatory Compliance Lead at Evnia ApS

Speaker

Regulatory Affairs & Intelligence Leadership | Market Access | Strategic Planning for MedTech & Pharma | Driving HealthCare Innovation Programs (EU, US, MENA)

Seasoned professional with ~25 years of experience working with US/EU/MENA MedTech and Pharma organisations with a go‐to‐ market, heads‐on mindset.My core focus is on healthcare innovation and delivering regulatory and clinical value. To serve this purpose, I drive regulatory and clinical evidence strategies and due diligence/remediation projects with a special focus on the support of start‐ups. I support MedTech and BioTech manufacturers in product lifecycle management, providing services such as remediation gap assessments, development of market access pathways, clinical development strategies and post‐market surveillance programs.Since 2018, I am the Regulatory Compliance Lead for Evnia ApS with a focus on development, implementation, direction and overseeing of regulatory compliance policies and procedures and regulatory strategic planning for MedTech and BioTech manufacturers globally.Substantial experience with management of diabetes, combination products, endoscopic devices, orthopedic and cardiovascular implants, bariatric devices, nanomaterials, borderline products and lately I have been working with AI‐based medical systems.My motivation has always been the improvement of care delivery and access to care for non‐privileged populations.Prompted by the potential of real‐world evidence and ongoing digital transformation of healthcare, I support manufacturers to identify optimal market options based on unmet medical needs and to address regulatory requirements with viable and sustainable activities.