CRED Project Management for Regulatory Affairs Professionals

CRED Project Management for Regulatory Affairs Professionals

Speaker biographies

Dipesh Mistry Dipesh Mistry started his regulatory journey after a brief encounter in Pharmacokinetics and has worked in departments such as CMC, Submission Management, Project Management and more recently working in the Oncology space within Pfizer’s Established Health business. He has worked in a variety of organisations including big pharma, generics, CROs and consultancies. Dipesh is a big supporter of education of science, and volunteers as a STEM ambassador for London and the South East of England. Gurdeep Bhangra Gurdeep has more than 15 years’ experience in global Regulatory Affairs. She began her career in the Pharma Industry supporting Marketing Applications and move into the CRO field as Regulatory Project Manager. Responsibilities include provision of strategic regulatory support to plan, build an delivery high quality regulatory clinical trial applications globally to support product development plans for the pharma industry. Joe Cheal Joe Cheal, from Imaginarium Learning and Development, has been training, consulting and coaching since 1993, working with thousands of people from a diverse range of companies over the past 25 years. He is a highly interactive and engaging speaker who focusses on practical solutions for ‘real-world’ implementation.” Sinéad Usher Sinéad Usher has almost 20 years of regulatory experience. She is currently the director of SMART Regulatory Services Limited which provides regulatory expertise to both large Pharma and CRO’s. Assignments have included Regulatory Project Manager roles with responsibility for a range of portfolios such as vaccines (biological), oncology, respiratory and more recently HIV. Other regulatory assignments have included: Labelling Audit Project, Regulatory Intelligence, Common Technical Document conversions and auditing dossiers for submission. Sinéad is a registered pharmacist and has a post graduate diploma in regulatory affairs with distinction.