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Virtual

Jul 20, 2023 4:00 PM - Jul 20, 2023 5:30 PM

(India Standard Time)

GMP Inspections - Key FDA, EMA & MHRA Updates Applicable to India

Presenters

Mark  Birse, MBA, MSc

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

Ramesh Dandu

Principal Consultant - Strategic Compliance Consulting, Parexel International, India

Lynne  Ensor, PhD

Lynne Ensor, PhD

Senior Global Director and Vice President, Pharma/Biotech Consulting, NSF, United States

Chris  Middendorf

Chris Middendorf

Vice President, Technical PC, Strategic Compliance Consulting, Parexel International, United States

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