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Nov 03, 2015 11:00 AM - Nov 03, 2015 12:00 PM

(Eastern Standard Time)

Online

Safety Operations Expert Panel Discussion: A New Approach to Ensuring Quality Safety Submissions the First Time

Presenters

David J. Balderson, PhD

David J. Balderson, PhD

VP Global Safety Operations, Covance, United States

Worked in Pharmacovigilance for over 17 years, initially at GSK in the UK, followed by nine years at Amgen in the US including roles as Head of Safety Operations and Head of Regulatory Operations prior to joining Sciformix in 2015. Managed significant global changes in safety processes to improve overall business efficiency including the development of an electronic interface for serious adverse event collection in clinical trials and the implementation of a new safety system. Experienced in developing flexible business models while ensuring compliance and quality delivery.

Calin A. Lungu, MD

Calin A. Lungu, MD

CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Mangesh  Kulkarni, MD

Mangesh Kulkarni, MD

Global Drug Safety - Physician and Head of Practice, Tata Consultancy Services, India

Dr Mangesh is MD physician with over 14 years of experience in Clinical Drug Development, Pharmacovigilance and Medical Affairs from diverse set-ups such as Academia, Contract Research Organization (CRO), Pharmaceutical and IT Industry. In his current role as Head of Safety Operations in the Drug Safety & Epidemiology at Novartis Healthcare Pvt Limited, Hyderabad, he is responsible for global ICSRs and Aggregate safety report submissions

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