Presenters
Mark Birse, MBA, MSc
Vice President, Technical, Parexel International, United Kingdom
Mark is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Prior to joining Parexel, Mark previously worked at the MHRA where held a number of leadership roles, including Deputy Director Inspection, Enforcement & Standards Division and Head of MHRA Inspectorate. In these roles, Mark worked extensively with international regulators including FDA, EMA and TGA developing compliance and risk-based inspection methodologies with a focus on inspection collaboration and reliance. He was an Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and has also assessed the capability and performance of international regulators
Ramesh Dandu
Principal Consultant - Strategic Compliance Consulting, Parexel International, India
Lynne Ensor, PhD
Senior Global Director and Vice President, Pharma/Biotech Consulting, NSF, United States
Chris Middendorf
Vice President, Technical PC, Strategic Compliance Consulting, Parexel International, United States
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